1

歐盟新版機械指令200642EC介紹

2

Speaker Introduction

George Shih石 緯 杰

ManagerProduct Certification

TUumlV NORD Taiwan Taichung Branch

4F No8 Huasin St North DistrictTaichung 404 Taiwan

TEL (04) 2202 7929 Ext 207Mobile 0912 795 035gshihtuv-nordcom

3

4

歐盟頒布第200642EC號「機械」指令並修正第9516EC號「電梯」指令之規定

資料來源及日期歐盟本（2006）年6月9日第L15724號歐盟公報

為符合當前科技水準提升對人類安全及健康之保護歐盟於2006年6月9日頒

布新訂定之第200642EC號「機械」指令廢止第9837EC號「機械」指令並

修正第9516EC號「電梯」指令之規定

Machinery Directive 9837EC -gt 200642ECLow Voltage Directive 200695ECEMC Directive 2004108EC

5

200642EC號「機械」指令大綱第1條（產品範圍）第11條規定本旨令「適用」之產品範圍為

(a) machinery(b) interchangeable equipment(c) safety components(d) lifting accessories(e) chains ropes and webbing(f) removable mechanical transmission devices(g) partly completed machinery第12條則規定本指令「排除適用」之產品範圍包括從(a) safety components

intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery至 (l) the following types of high-voltage electrical equipment

switch gear and control gear transformers等12項之產品均排除於本旨令之適用範圍

第2條（名詞定義）本條規定相關「名詞定義」

6

200642EC號「機械」指令大綱

第3條（特定指令）本指令附件1所列機械之「危險」（Hazards）倘同時為其

他指令（部分或全部）更精確之所涵蓋者則適用該等其他「特定指令」

（Specific Directives）

第4條（市場監督）會員國應指定權責機關負責「市場監督」並確保機械產品

之「符合性」

第5條（進入市場或提供服務）在產品進入市場或提供服務之前製造商或授權

代表應（a）確保該產品符合本旨令附件1有關基本健康及安全規範之要求（b）建立技術檔案（c）提供必要資訊（d）進行符合性評估（e）為符合性之聲

明（f）黏貼CE標示

第6條（自由流通）各會員國對於符合本旨令之產品不得禁止流通進入市場

第7條（符合性推定及調合標準）凡依規定有CE標誌及符合性聲明之機械產品應

被認為符合本指令之規定（第71條）機械之製造符合調合標準者應被推定符

合基本健康及安全規範之要求（第72條）

7

200642EC號「機械」指令大綱

第8條至第10條（特定措施）第8條係規定有關禁止「不符合規定產品」之上市以及更新「安全零組件清單」（indicative list of safety components）等之措施第9條係規定有關「危險機械」之特別措施第10條則規定調合標準「爭議處理」程序第11條（防衛條款）當產品有損及健康及安全之要求時各會員國應採取必要措施將產品自市場上「回收」並通知執委會

第12條（符合性評估程序）製造商或授權代表應確保機械產品符合本指令之規定並於第122條第123條或第124條等3種符合性評估「模組」中選擇ㄧ種適用之第（122條）

第13條（半成品程序）機械半成品（partly completed machinery）之製造商或授權代表應建立備置（a）附件Ⅶ B部分之技術文件（b）附件Ⅵ之assembly instructions」（c）附件Ⅱ（part 1 Section B）之「declaration of incorporation」

8

200642EC號「機械」指令大綱

第14條（認證機構）各會員國應將其所指定之「認證機構」(符合性評鑑機構)（the notified bodies）通知執委會及其他會員國並依據附件Ⅵ之標準評估「認證機構」第16條及第17條（CE標示）第16條規定應依附件Ⅲ之規定黏貼「CE標示」第17條則係「不符合CE標示」之相關規定第18條至第23條係有關「資料機密性」（Confidentiality）「會員國合作」（Cooperation between Member States）「法定救濟」（Legal remedies）「資訊散佈」（Dissemination of information）「委員會」（Committee）「處罰」（Penalties）等之規定第24條本條修正第9516EC號「電梯」指令第12條及第13條有關「電梯」（lift）之規定第25條本條規定「廢止」第9837EC「機械」指令

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

2

Speaker Introduction

George Shih石 緯 杰

ManagerProduct Certification

TUumlV NORD Taiwan Taichung Branch

4F No8 Huasin St North DistrictTaichung 404 Taiwan

TEL (04) 2202 7929 Ext 207Mobile 0912 795 035gshihtuv-nordcom

3

4

歐盟頒布第200642EC號「機械」指令並修正第9516EC號「電梯」指令之規定

資料來源及日期歐盟本（2006）年6月9日第L15724號歐盟公報

為符合當前科技水準提升對人類安全及健康之保護歐盟於2006年6月9日頒

布新訂定之第200642EC號「機械」指令廢止第9837EC號「機械」指令並

修正第9516EC號「電梯」指令之規定

Machinery Directive 9837EC -gt 200642ECLow Voltage Directive 200695ECEMC Directive 2004108EC

5

200642EC號「機械」指令大綱第1條（產品範圍）第11條規定本旨令「適用」之產品範圍為

(a) machinery(b) interchangeable equipment(c) safety components(d) lifting accessories(e) chains ropes and webbing(f) removable mechanical transmission devices(g) partly completed machinery第12條則規定本指令「排除適用」之產品範圍包括從(a) safety components

intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery至 (l) the following types of high-voltage electrical equipment

switch gear and control gear transformers等12項之產品均排除於本旨令之適用範圍

第2條（名詞定義）本條規定相關「名詞定義」

6

200642EC號「機械」指令大綱

第3條（特定指令）本指令附件1所列機械之「危險」（Hazards）倘同時為其

他指令（部分或全部）更精確之所涵蓋者則適用該等其他「特定指令」

（Specific Directives）

第4條（市場監督）會員國應指定權責機關負責「市場監督」並確保機械產品

之「符合性」

第5條（進入市場或提供服務）在產品進入市場或提供服務之前製造商或授權

代表應（a）確保該產品符合本旨令附件1有關基本健康及安全規範之要求（b）建立技術檔案（c）提供必要資訊（d）進行符合性評估（e）為符合性之聲

明（f）黏貼CE標示

第6條（自由流通）各會員國對於符合本旨令之產品不得禁止流通進入市場

第7條（符合性推定及調合標準）凡依規定有CE標誌及符合性聲明之機械產品應

被認為符合本指令之規定（第71條）機械之製造符合調合標準者應被推定符

合基本健康及安全規範之要求（第72條）

7

200642EC號「機械」指令大綱

第8條至第10條（特定措施）第8條係規定有關禁止「不符合規定產品」之上市以及更新「安全零組件清單」（indicative list of safety components）等之措施第9條係規定有關「危險機械」之特別措施第10條則規定調合標準「爭議處理」程序第11條（防衛條款）當產品有損及健康及安全之要求時各會員國應採取必要措施將產品自市場上「回收」並通知執委會

第12條（符合性評估程序）製造商或授權代表應確保機械產品符合本指令之規定並於第122條第123條或第124條等3種符合性評估「模組」中選擇ㄧ種適用之第（122條）

第13條（半成品程序）機械半成品（partly completed machinery）之製造商或授權代表應建立備置（a）附件Ⅶ B部分之技術文件（b）附件Ⅵ之assembly instructions」（c）附件Ⅱ（part 1 Section B）之「declaration of incorporation」

8

200642EC號「機械」指令大綱

第14條（認證機構）各會員國應將其所指定之「認證機構」(符合性評鑑機構)（the notified bodies）通知執委會及其他會員國並依據附件Ⅵ之標準評估「認證機構」第16條及第17條（CE標示）第16條規定應依附件Ⅲ之規定黏貼「CE標示」第17條則係「不符合CE標示」之相關規定第18條至第23條係有關「資料機密性」（Confidentiality）「會員國合作」（Cooperation between Member States）「法定救濟」（Legal remedies）「資訊散佈」（Dissemination of information）「委員會」（Committee）「處罰」（Penalties）等之規定第24條本條修正第9516EC號「電梯」指令第12條及第13條有關「電梯」（lift）之規定第25條本條規定「廢止」第9837EC「機械」指令

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

3

4

歐盟頒布第200642EC號「機械」指令並修正第9516EC號「電梯」指令之規定

資料來源及日期歐盟本（2006）年6月9日第L15724號歐盟公報

為符合當前科技水準提升對人類安全及健康之保護歐盟於2006年6月9日頒

布新訂定之第200642EC號「機械」指令廢止第9837EC號「機械」指令並

修正第9516EC號「電梯」指令之規定

Machinery Directive 9837EC -gt 200642ECLow Voltage Directive 200695ECEMC Directive 2004108EC

5

200642EC號「機械」指令大綱第1條（產品範圍）第11條規定本旨令「適用」之產品範圍為

(a) machinery(b) interchangeable equipment(c) safety components(d) lifting accessories(e) chains ropes and webbing(f) removable mechanical transmission devices(g) partly completed machinery第12條則規定本指令「排除適用」之產品範圍包括從(a) safety components

intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery至 (l) the following types of high-voltage electrical equipment

switch gear and control gear transformers等12項之產品均排除於本旨令之適用範圍

第2條（名詞定義）本條規定相關「名詞定義」

6

200642EC號「機械」指令大綱

第3條（特定指令）本指令附件1所列機械之「危險」（Hazards）倘同時為其

他指令（部分或全部）更精確之所涵蓋者則適用該等其他「特定指令」

（Specific Directives）

第4條（市場監督）會員國應指定權責機關負責「市場監督」並確保機械產品

之「符合性」

第5條（進入市場或提供服務）在產品進入市場或提供服務之前製造商或授權

代表應（a）確保該產品符合本旨令附件1有關基本健康及安全規範之要求（b）建立技術檔案（c）提供必要資訊（d）進行符合性評估（e）為符合性之聲

明（f）黏貼CE標示

第6條（自由流通）各會員國對於符合本旨令之產品不得禁止流通進入市場

第7條（符合性推定及調合標準）凡依規定有CE標誌及符合性聲明之機械產品應

被認為符合本指令之規定（第71條）機械之製造符合調合標準者應被推定符

合基本健康及安全規範之要求（第72條）

7

200642EC號「機械」指令大綱

第8條至第10條（特定措施）第8條係規定有關禁止「不符合規定產品」之上市以及更新「安全零組件清單」（indicative list of safety components）等之措施第9條係規定有關「危險機械」之特別措施第10條則規定調合標準「爭議處理」程序第11條（防衛條款）當產品有損及健康及安全之要求時各會員國應採取必要措施將產品自市場上「回收」並通知執委會

第12條（符合性評估程序）製造商或授權代表應確保機械產品符合本指令之規定並於第122條第123條或第124條等3種符合性評估「模組」中選擇ㄧ種適用之第（122條）

第13條（半成品程序）機械半成品（partly completed machinery）之製造商或授權代表應建立備置（a）附件Ⅶ B部分之技術文件（b）附件Ⅵ之assembly instructions」（c）附件Ⅱ（part 1 Section B）之「declaration of incorporation」

8

200642EC號「機械」指令大綱

第14條（認證機構）各會員國應將其所指定之「認證機構」(符合性評鑑機構)（the notified bodies）通知執委會及其他會員國並依據附件Ⅵ之標準評估「認證機構」第16條及第17條（CE標示）第16條規定應依附件Ⅲ之規定黏貼「CE標示」第17條則係「不符合CE標示」之相關規定第18條至第23條係有關「資料機密性」（Confidentiality）「會員國合作」（Cooperation between Member States）「法定救濟」（Legal remedies）「資訊散佈」（Dissemination of information）「委員會」（Committee）「處罰」（Penalties）等之規定第24條本條修正第9516EC號「電梯」指令第12條及第13條有關「電梯」（lift）之規定第25條本條規定「廢止」第9837EC「機械」指令

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

4

歐盟頒布第200642EC號「機械」指令並修正第9516EC號「電梯」指令之規定

資料來源及日期歐盟本（2006）年6月9日第L15724號歐盟公報

為符合當前科技水準提升對人類安全及健康之保護歐盟於2006年6月9日頒

布新訂定之第200642EC號「機械」指令廢止第9837EC號「機械」指令並

修正第9516EC號「電梯」指令之規定

Machinery Directive 9837EC -gt 200642ECLow Voltage Directive 200695ECEMC Directive 2004108EC

5

200642EC號「機械」指令大綱第1條（產品範圍）第11條規定本旨令「適用」之產品範圍為

(a) machinery(b) interchangeable equipment(c) safety components(d) lifting accessories(e) chains ropes and webbing(f) removable mechanical transmission devices(g) partly completed machinery第12條則規定本指令「排除適用」之產品範圍包括從(a) safety components

intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery至 (l) the following types of high-voltage electrical equipment

switch gear and control gear transformers等12項之產品均排除於本旨令之適用範圍

第2條（名詞定義）本條規定相關「名詞定義」

6

200642EC號「機械」指令大綱

第3條（特定指令）本指令附件1所列機械之「危險」（Hazards）倘同時為其

他指令（部分或全部）更精確之所涵蓋者則適用該等其他「特定指令」

（Specific Directives）

第4條（市場監督）會員國應指定權責機關負責「市場監督」並確保機械產品

之「符合性」

第5條（進入市場或提供服務）在產品進入市場或提供服務之前製造商或授權

代表應（a）確保該產品符合本旨令附件1有關基本健康及安全規範之要求（b）建立技術檔案（c）提供必要資訊（d）進行符合性評估（e）為符合性之聲

明（f）黏貼CE標示

第6條（自由流通）各會員國對於符合本旨令之產品不得禁止流通進入市場

第7條（符合性推定及調合標準）凡依規定有CE標誌及符合性聲明之機械產品應

被認為符合本指令之規定（第71條）機械之製造符合調合標準者應被推定符

合基本健康及安全規範之要求（第72條）

7

200642EC號「機械」指令大綱

第8條至第10條（特定措施）第8條係規定有關禁止「不符合規定產品」之上市以及更新「安全零組件清單」（indicative list of safety components）等之措施第9條係規定有關「危險機械」之特別措施第10條則規定調合標準「爭議處理」程序第11條（防衛條款）當產品有損及健康及安全之要求時各會員國應採取必要措施將產品自市場上「回收」並通知執委會

第12條（符合性評估程序）製造商或授權代表應確保機械產品符合本指令之規定並於第122條第123條或第124條等3種符合性評估「模組」中選擇ㄧ種適用之第（122條）

第13條（半成品程序）機械半成品（partly completed machinery）之製造商或授權代表應建立備置（a）附件Ⅶ B部分之技術文件（b）附件Ⅵ之assembly instructions」（c）附件Ⅱ（part 1 Section B）之「declaration of incorporation」

8

200642EC號「機械」指令大綱

第14條（認證機構）各會員國應將其所指定之「認證機構」(符合性評鑑機構)（the notified bodies）通知執委會及其他會員國並依據附件Ⅵ之標準評估「認證機構」第16條及第17條（CE標示）第16條規定應依附件Ⅲ之規定黏貼「CE標示」第17條則係「不符合CE標示」之相關規定第18條至第23條係有關「資料機密性」（Confidentiality）「會員國合作」（Cooperation between Member States）「法定救濟」（Legal remedies）「資訊散佈」（Dissemination of information）「委員會」（Committee）「處罰」（Penalties）等之規定第24條本條修正第9516EC號「電梯」指令第12條及第13條有關「電梯」（lift）之規定第25條本條規定「廢止」第9837EC「機械」指令

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

5

200642EC號「機械」指令大綱第1條（產品範圍）第11條規定本旨令「適用」之產品範圍為

(a) machinery(b) interchangeable equipment(c) safety components(d) lifting accessories(e) chains ropes and webbing(f) removable mechanical transmission devices(g) partly completed machinery第12條則規定本指令「排除適用」之產品範圍包括從(a) safety components

intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery至 (l) the following types of high-voltage electrical equipment

switch gear and control gear transformers等12項之產品均排除於本旨令之適用範圍

第2條（名詞定義）本條規定相關「名詞定義」

6

200642EC號「機械」指令大綱

第3條（特定指令）本指令附件1所列機械之「危險」（Hazards）倘同時為其

他指令（部分或全部）更精確之所涵蓋者則適用該等其他「特定指令」

（Specific Directives）

第4條（市場監督）會員國應指定權責機關負責「市場監督」並確保機械產品

之「符合性」

第5條（進入市場或提供服務）在產品進入市場或提供服務之前製造商或授權

代表應（a）確保該產品符合本旨令附件1有關基本健康及安全規範之要求（b）建立技術檔案（c）提供必要資訊（d）進行符合性評估（e）為符合性之聲

明（f）黏貼CE標示

第6條（自由流通）各會員國對於符合本旨令之產品不得禁止流通進入市場

第7條（符合性推定及調合標準）凡依規定有CE標誌及符合性聲明之機械產品應

被認為符合本指令之規定（第71條）機械之製造符合調合標準者應被推定符

合基本健康及安全規範之要求（第72條）

7

200642EC號「機械」指令大綱

第8條至第10條（特定措施）第8條係規定有關禁止「不符合規定產品」之上市以及更新「安全零組件清單」（indicative list of safety components）等之措施第9條係規定有關「危險機械」之特別措施第10條則規定調合標準「爭議處理」程序第11條（防衛條款）當產品有損及健康及安全之要求時各會員國應採取必要措施將產品自市場上「回收」並通知執委會

第12條（符合性評估程序）製造商或授權代表應確保機械產品符合本指令之規定並於第122條第123條或第124條等3種符合性評估「模組」中選擇ㄧ種適用之第（122條）

第13條（半成品程序）機械半成品（partly completed machinery）之製造商或授權代表應建立備置（a）附件Ⅶ B部分之技術文件（b）附件Ⅵ之assembly instructions」（c）附件Ⅱ（part 1 Section B）之「declaration of incorporation」

8

200642EC號「機械」指令大綱

第14條（認證機構）各會員國應將其所指定之「認證機構」(符合性評鑑機構)（the notified bodies）通知執委會及其他會員國並依據附件Ⅵ之標準評估「認證機構」第16條及第17條（CE標示）第16條規定應依附件Ⅲ之規定黏貼「CE標示」第17條則係「不符合CE標示」之相關規定第18條至第23條係有關「資料機密性」（Confidentiality）「會員國合作」（Cooperation between Member States）「法定救濟」（Legal remedies）「資訊散佈」（Dissemination of information）「委員會」（Committee）「處罰」（Penalties）等之規定第24條本條修正第9516EC號「電梯」指令第12條及第13條有關「電梯」（lift）之規定第25條本條規定「廢止」第9837EC「機械」指令

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

6

200642EC號「機械」指令大綱

第3條（特定指令）本指令附件1所列機械之「危險」（Hazards）倘同時為其

他指令（部分或全部）更精確之所涵蓋者則適用該等其他「特定指令」

（Specific Directives）

第4條（市場監督）會員國應指定權責機關負責「市場監督」並確保機械產品

之「符合性」

第5條（進入市場或提供服務）在產品進入市場或提供服務之前製造商或授權

代表應（a）確保該產品符合本旨令附件1有關基本健康及安全規範之要求（b）建立技術檔案（c）提供必要資訊（d）進行符合性評估（e）為符合性之聲

明（f）黏貼CE標示

第6條（自由流通）各會員國對於符合本旨令之產品不得禁止流通進入市場

第7條（符合性推定及調合標準）凡依規定有CE標誌及符合性聲明之機械產品應

被認為符合本指令之規定（第71條）機械之製造符合調合標準者應被推定符

合基本健康及安全規範之要求（第72條）

7

200642EC號「機械」指令大綱

第8條至第10條（特定措施）第8條係規定有關禁止「不符合規定產品」之上市以及更新「安全零組件清單」（indicative list of safety components）等之措施第9條係規定有關「危險機械」之特別措施第10條則規定調合標準「爭議處理」程序第11條（防衛條款）當產品有損及健康及安全之要求時各會員國應採取必要措施將產品自市場上「回收」並通知執委會

第12條（符合性評估程序）製造商或授權代表應確保機械產品符合本指令之規定並於第122條第123條或第124條等3種符合性評估「模組」中選擇ㄧ種適用之第（122條）

第13條（半成品程序）機械半成品（partly completed machinery）之製造商或授權代表應建立備置（a）附件Ⅶ B部分之技術文件（b）附件Ⅵ之assembly instructions」（c）附件Ⅱ（part 1 Section B）之「declaration of incorporation」

8

200642EC號「機械」指令大綱

第14條（認證機構）各會員國應將其所指定之「認證機構」(符合性評鑑機構)（the notified bodies）通知執委會及其他會員國並依據附件Ⅵ之標準評估「認證機構」第16條及第17條（CE標示）第16條規定應依附件Ⅲ之規定黏貼「CE標示」第17條則係「不符合CE標示」之相關規定第18條至第23條係有關「資料機密性」（Confidentiality）「會員國合作」（Cooperation between Member States）「法定救濟」（Legal remedies）「資訊散佈」（Dissemination of information）「委員會」（Committee）「處罰」（Penalties）等之規定第24條本條修正第9516EC號「電梯」指令第12條及第13條有關「電梯」（lift）之規定第25條本條規定「廢止」第9837EC「機械」指令

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

7

200642EC號「機械」指令大綱

第8條至第10條（特定措施）第8條係規定有關禁止「不符合規定產品」之上市以及更新「安全零組件清單」（indicative list of safety components）等之措施第9條係規定有關「危險機械」之特別措施第10條則規定調合標準「爭議處理」程序第11條（防衛條款）當產品有損及健康及安全之要求時各會員國應採取必要措施將產品自市場上「回收」並通知執委會

第12條（符合性評估程序）製造商或授權代表應確保機械產品符合本指令之規定並於第122條第123條或第124條等3種符合性評估「模組」中選擇ㄧ種適用之第（122條）

第13條（半成品程序）機械半成品（partly completed machinery）之製造商或授權代表應建立備置（a）附件Ⅶ B部分之技術文件（b）附件Ⅵ之assembly instructions」（c）附件Ⅱ（part 1 Section B）之「declaration of incorporation」

8

200642EC號「機械」指令大綱

第14條（認證機構）各會員國應將其所指定之「認證機構」(符合性評鑑機構)（the notified bodies）通知執委會及其他會員國並依據附件Ⅵ之標準評估「認證機構」第16條及第17條（CE標示）第16條規定應依附件Ⅲ之規定黏貼「CE標示」第17條則係「不符合CE標示」之相關規定第18條至第23條係有關「資料機密性」（Confidentiality）「會員國合作」（Cooperation between Member States）「法定救濟」（Legal remedies）「資訊散佈」（Dissemination of information）「委員會」（Committee）「處罰」（Penalties）等之規定第24條本條修正第9516EC號「電梯」指令第12條及第13條有關「電梯」（lift）之規定第25條本條規定「廢止」第9837EC「機械」指令

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

8

200642EC號「機械」指令大綱

第14條（認證機構）各會員國應將其所指定之「認證機構」(符合性評鑑機構)（the notified bodies）通知執委會及其他會員國並依據附件Ⅵ之標準評估「認證機構」第16條及第17條（CE標示）第16條規定應依附件Ⅲ之規定黏貼「CE標示」第17條則係「不符合CE標示」之相關規定第18條至第23條係有關「資料機密性」（Confidentiality）「會員國合作」（Cooperation between Member States）「法定救濟」（Legal remedies）「資訊散佈」（Dissemination of information）「委員會」（Committee）「處罰」（Penalties）等之規定第24條本條修正第9516EC號「電梯」指令第12條及第13條有關「電梯」（lift）之規定第25條本條規定「廢止」第9837EC「機械」指令

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

9

200642EC號「機械」指令大綱

第26條 (轉換)各會員國應於2008年6月29日前將本指令「轉換」為其國內法並自

2009年12月29日起正式「實施」

第27條在2011年6月29日前各會員國得允許「portable cartridge operated fixing and other impact machinery」等產品之行銷上市

第26條本指令自公告日起20天內「生效」

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

10

Introduction

Machinery Directive 200642EC becomes applicable on 29 December 2009superseding the existing Machinery Directive 9837EC While the two are broadlysimilar there are significant differences that will affect machine builders those performing final assembly and CE marking of machinery and those placing imported machinery on the market in the European Economic Area

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

11

Background

From 29 December 2009 Directive 200642EC regulates the placing on the market and the putting into service of machinery in the European Union replacing the existing Directive 9837EC This recasting of the Machinery Directive which is a comprehensive amendment is intended to extend the scope improve clarity remove some of the acknowledged flaws that existed in the old Directive provide an optional route to conformity assessment through quality assurance for manufacturers of some types of machinery especially prototype and bespoke machinery and introduce provisions for market surveillance EU Member States are required to implement the Directive through national legislation and theGovernment will do this by introducing new Machinery Regulations

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

12

TimescalesThis is not the first time that the Machinery Directive has undergone changes It was originally known as Directive 89392EEC then it was amended by Directives 91386EEC and 9368EEC Directive 9837EC was created to consolidate the original Directive and its amendments

In 2001 the European Commission proposed to amend Directive 9837EC and following protracted negotiations an agreed text was published in late 2005Directive 200642EC was published in the Official Journal of the European Union on 9 June 2006 as the third amendment of the Machinery Directive

Member States have until 29 June 2008 to transpose the Directive into their domestic legislation Government is to publish new Machinery Regulations in June 2008which will come into force in December 2009 in accordance with the Directive The Machinery Regulations 2008 will replace the Supply of Machinery (Safety) Regulations 1992 as well as the 1994 and 2005 amendments

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

13

Directive in the new Machinery Regulations and not the text of the Machinery Directive itselfCEN (the European standards organisation) has until 29 December 2009 to adapt approximately 650 Harmonised standards to the new Directive which it admits will be a challengeOn 29 December 2009 the new Directive will become applicable and the old Directive will be repealed There is no transition period the old Directive and Regulations continue to apply until the new Directive becomes applicable andthe new Regulations come into forceFor cartridge-operated fixing tool (槍彈推動打釘工具)and other impact machinerywhich were previously excluded from the Machinery Directive there is a transition period until 29 June 2011

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

14

ScopeChanges to the scope of the Directive and the fact that Article 24 of the new Machinery Directive also amends the Lifts Directive 9516EC mean that construction site hoists are now included and lifts with a travel speed no greater than 015ms are now excluded from the Lifts Directive these are now subject to the Machinery Directive insteadCartridge-operated fixing and other impact machinery are no longer excluded from the Machinery DirectiveWhereas the old Directive stated that the Low-Voltage Directive (LVD 7323EEC)should be applied in situations where the risks are mainly electrical Article 1 of the new Directive identifies specific types of equipment to which the LVD (now 200695EC) should be applied Note however that the EHSRs of the LVD willbecome part of the MachineryDirective requirements for electrical equipmentAs with other New Approach EU Directives the new Machinery Directive applies to machinery placed on the market and put into service throughout the EEA ndash which consists of the EU Member States plus Iceland Norway and Liechtenstein

General overview

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

15

Partly completed machinery

Whereas the old Directive referred to machinery which cannot function independently the new Directive introduces - and more clearly explains - the concept of partly completed machinery Under the new Directive a manufacturer of partly completed machines or his authorised representative must prepare the relevant technical documentation assembly instructions and declaration of incorporation Note that authorities can perform market surveillance on partly completed machinery though Article 11 is not applicable this being the Safeguard clause that provides for unsafe machinery to be withdrawn from the market or prohibited from being placed on the market or put into service

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

16

Exclusions

The new Directive removes the exclusion relating to machinery for which the only power source is directly applied human effortMedical devices are no longer specifically excluded but note that these are covered by the Medical Devices DirectiveThe new Directive excludes weapons including firearms whereas the old Directive excluded firearmsThere is a clearer definition of the means of transport excludedThe following are now excluded as they are covered by the Low-Voltage Directivebull Household appliances intended for domestic usebull Audio and video equipmentbull Information technology equipmentbull Ordinary office machinerybull Low-voltage switchgear and controlgearbull Electric motorsIn addition high-voltage switchgear controlgear and transformers are excluded

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

17

Definitions

In comparison with the old Directive formal definitions areprovided for many more terms2(c) There is now a clearer definition of safety component withinthe body of the Directive plus there is now an indicative list ofsafety components in Annex V

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

18

Article 13 - Procedure for partly complete machineryThis new Article explains what a manufacturer of partly completedmachinery or his authorised representative must do before thepartly completed machinery is placed on the marketArticle 24 - Amendment of Directive 9516ECThis new Article amends the Lifts Directive defines lift andcarrier and makes it far easier to identify which Directive shouldbe applied

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

19

At the heart of the Directive are the Essential Health and Safety Requirements (EHSRs) and these have been clarified and placed in a more logical order Because of the inclusion of construction site hoists and slow-moving lifts in therevised scope there are new EHSRs relating to risks associated with lifts serving fixed landingsManufacturers that choose to adopt the new Directive before it comes into force will find that by doing so they automatically fulfil the old EHSRs However the change to the EHSRs means that it cannot be assumed that the harmonisedstandards will be the same so there is currently no list of harmonised standards with which to comply if claiming conformity with the new Directive (the Commission is due to publish a list before the Directive comes into force) In practical and technical terms working to the existing harmonised standards will result in conformance with the EHSRs of 200642EC though that will not give legal compliance Because of this issue with the EHSRs and the fact that the oldDirective remains in force until the new one supersedes it manufacturers must continue claiming conformity with 9837EC until 29 December 2007 After that date machinery can only be placed on the market withreference to Directive 200642EC

Essential Health and Safety Requirements (1)

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

20

Change in Essential Health and Safety Requirements (1)

117 Operating positions (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 321 for mobile machinery and EHSR 4211 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

118 Seating (ldquonewrdquo EHSR)Incorporates elements from the previous EHSR 322 and EHSR 323 for mobile machinery and EHSR 4212 for lifting machineryThese requirements are now generally applicable and not only to mobile machinery or machines for lifting

1 Essential Health and Safety Requirements11 General Remarks

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

21

Change in Essential Health and Safety Requirements (2)

The following additional requirementsldquoThe parameters of the machinery must not change in an uncontrolled way where such change may lead to hazardous situationsrdquoldquoThe safety-related parts of the control system must apply in a coherent way to the whole of an assembly of machinery andor partly completed machineryrdquoldquoFor cable-less control an automatic stop must be activated when correct control signals are not received including loss of communicationrdquo

12 Control systems (previously ldquoControlsrdquo)121 Safety and reliability of control systemsNew elements (besides smaller modifications of the formulation)

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

22

Change in Essential Health and Safety Requirements (3)

The preference for pictograms for marking of devices has been added Concerning the possibility that persons can be in a danger zone during starting without being observed by the operatorAddition of a technical alternative for (direct or indirect) observation design of the control system in such a way that ldquostarting is prevented while someone is in the danger zonerdquoThis requirement is now applicable to ldquoeach control positionrdquo (in the past only to the main control position)A new provision is added for ensuring that if necessary machinery can only be controlled from control positions located in one or more predetermined zones or locationsldquoNewrdquo provisions incorporating elements from previous 321 and thus making their application general and not only to mobile machineryMeasures for ensuring that in case of more than one control position the use of one of them precludes the use of the others (except for stop controls and emergency stops)When machinery has two or more operating positions the presence of all required devices at each position and the designlocation of these devices without the operators hindering or putting each other into danger

122 Control devices

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

23

Change in Essential Health and Safety Requirements ()

New requirement ldquoIf safety requires that starting andor stopping must be performed in a specific sequence there must be devices which ensure that theseoperations are performed in the correct orderrdquo

The effect of the devices for normal stop is now expressed in terms of ldquofunctionsrdquo (previously in terms of ldquomoving partsrdquo)

ldquoWhere for operational reasons a stop control that does not cut off the energy supply to the actuators is required the stop condition must be monitored and maintainedrdquo

123Starting

124 Stopping (previously ldquoStopping devicerdquo)1241 Normal stop (new numbering)

1242 Operational stop (new requirement)

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

24

Change in Essential Health and Safety Requirements ()

ldquoThe emergency stop function must be available and operational at all times regardless of the operating moderdquoldquoEmergency stop devices must be a back-up to other safeguarding measures and not a substitute for themrdquo

Besides limited reformulation the requirement concerning the (4)conditions in the control or operating modes for interventions with certain safety provisions disabled is completed with the following

ldquoIf these four conditions cannot be fulfilled simultaneously thecontrol or operating mode selector must activate other protective measures designed and constructed to ensure a safe intervention zonerdquo

1243 Emergency stop (new numbering)New elements

125 Selection of control or operating modes (previously ldquoMode selectionrdquo)

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

25

Change in Essential Health and Safety Requirements ()

Addition of the following criterion in case of a failure of the power supplyldquothe parameters of the machinery must not change in an uncontrolled way when such change can lead to hazardous situationsrdquo

Explicit extension of the requirement to the different ldquophases of liferdquo of the machinery ldquotransportation assembly dismantling and any other action involving the machineryrdquo(see also 112a)

126 Failure of the power supply

13 Protection against mechanical hazards131 Risk of loss of stability (new heading)

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

26

Change in Essential Health and Safety Requirements ()

This is in fact part of the previous EHSR 341 concerning mobile machinery ldquoWhen a part of the machinery has been stopped any drift away from the stopping position for whatever reason other than action on the control devices must be prevented or must be such that it does not present a hazardrdquoThe modification makes the requirement generally applicable instead of only to mobile machinery

ldquoNewrdquo requirement that guards and protective devices must ldquobe securely held in placerdquo previously in 1421 for fixed guards (and thus made more general)ldquoNewrdquo requirement that ldquowhere possible guards must protect against the ejection or falling of materials and objectsrdquo previously in 1422 for ldquotype Brdquomovable guards intended for moving parts directly involved in the process and in 1423 for adjustable guards (and thus made more generalNew requirement adding to the previous point that where possible guards must protect against emissions generated by the machinery

139 Risks of uncontrolled movements (new requirement)

14 Required characteristics of guards and protective devices141 General requirements

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

27

Change in Essential Health and Safety Requirements ()

Additional requirement ldquoTheir fixing systems must remain attached to the guards or to the machinery when the guards are removedrdquo

Addition of the following text ldquoThe level of noise emission may be assessed with reference to comparative emission data for similar machineryrdquo

Addition of the following text ldquoThe level of vibration emission may be assessed with reference to comparative emission data for similar machineryrdquo

1421 (Special requirements for guards) Fixed guards

15 Risks due to other hazards158 Noise

159 Vibrations

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

28

Change in Essential Health and Safety Requirements ()

Addition concerning parts of machinery where persons are liable to move about or stand ldquoWhere appropriate these parts must be fitted with handholds that are fixed relative to the user and that enable them to maintain their stabilityrdquo

This is the text of the previous EHSR 4128 concerning machinery with lifting hazards ldquoMachinery in need of protection against the effects of lightning while being used must be fitted with a system for conducting the resultant electrical charge to earthrdquoThe modification makes the requirement generally applicable instead of only to machinery for lifting

1515 Risk of slipping tripping or falling

1516 Lightning (ldquoNewrdquo requirement)

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

29

Change in Essential Health and Safety Requirements ()

the business name and full address of the manufacturer and where applicable his authorised representativedesignation of the machinerythe year of construction that is the year in which the manufacturing process is completedIt is prohibited to pre-date or post-date the machinery when affixing the CE marking

Besides the new rules concerning languages and the message of previous 174h) we find here the follow new provision (ldquocrdquo) ldquoThe contents of the instructions must cover not only the intended use of the machinery but also take into account any reasonably foreseeable misuse thereofrdquo See also comments to 112a)

17 Information (previously ldquoIndicatorsrdquo)173 Marking of machinery

1741 General principles for the drafting of instructions

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

30

Change in Essential Health and Safety Requirements ()

The list of subjects that must be included in the instructions is restructured and completed with the explicit or more explicit citation of a number of additional itemsBesides this restructuring and completion some particular changes are mentioned below

Concerning the information on airborne noise emissions to be given by the manufacturer we find the following new elementsThe limit for the obligation to inform about the sound power level has been reduced from 85 to 80 dB(A)ldquoWhenever sound emission values are indicated the uncertainties surrounding these values must be specifiedrdquoldquoWhere specific Community Directives lay down other requirements for the measurement of sound pressure levels or sound power levels those Directives must be applied and the corresponding provisions of this section shall not applyrdquo

1742 Contents of the instructionsGeneral

Particular information on noise emissions

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

31

Change in Essential Health and Safety Requirements ()

Item g) of the old EHSR 174 concerning the specific information for machinery intended for use in a potentially explosive atmosphere is deletedA new item has been added concerning the emission of non-ionising radiation ldquo(v) where machinery is likely to emit non-ionising radiation which may cause harm to persons in particular persons with active or non-active implantable medical devices information concerning the radiation emitted for the operator and exposed personsrdquo

Some other particular modifications

Extension of the scope of this chapter 21 to machinery for cosmetics or pharmaceutical products

2 Supplementary EHSR for certain categories of machinery21 Foodstuffs machinery and machinery for cosmetics or pharmaceutical products (previously ldquoAgri-foodstuffs machineryrdquo)

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

32

Change in Essential Health and Safety Requirements ()

New element in 221 Additional requirement for the design of handles for making starting and stopping straightforwardConcerning the information on vibrations to be given by the manufacturer we find the following changes and new elements in 2211The value to be given becomes ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methodsNew 222 with additional general requirements for portable fixing and other impact machinery and specific requirements for cartridge operated portable fixing and other impact machinery

22 Portable hand-held andor hand-guided machinery

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

33

Change in Essential Health and Safety Requirements ()

The requirement for a ldquorestraint systemrdquo (previously rdquosafety belt or equivalent devicerdquo) for the persons in case of ROPS is reformulated and also extended to TOPS and FOPSIt applies now to ldquomachinery equipped withrdquo such system(s) instead of machinery ldquowith provision for a ROPSrdquoSuch ldquorestraint systemrdquo is no longer required if this system ldquoincreases the riskrdquo

The requirement in b) about the ldquorisk of ejection of pieces of woodrdquo has been made more general by reformulation into ldquothe risk of ejection of work pieces and parts of themrdquo

23 Machinery for working wood and material with similar physical characteristics

3 Supplementary EHSR to offset hazards due to mobility322 Seating

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

34

Change in Essential Health and Safety Requirements ()

Detailed general requirements concerning remote control

The requirement from EHSR 122 concerning acoustic andor visual warning signals before starting if the operator can not observe persons in the danger zone in the past not applicable to the mobility function applies now in the case of reversing

More detailed requirements concerning remote control

33 Control systems (previously ldquoControlsrdquo)Introduction added containing among others following elements

331 Control devices

333 Travelling function

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

35

Change in Essential Health and Safety Requirements ()

Extension of the scope of this requirement to ldquotipping overrdquoThe requirement is now for a ROPS or TOPS (previously for ldquoanchorage pointsrdquo) and exception from it in cases where the ROPS or TOPS ldquoincreases the riskrdquoDeletion of the list with examples of machines for which ROPS is required

More general formulation concerning the persons to be protected (now including also ldquoother person(s)rdquo)The requirement is now for FOPS (previously for ldquoanchorage pointsrdquo)

Addition of a rule concerning the design of the guard of the driving device (ldquoit must be possible to open this guardhelliprdquo)

343 Roll-over and tip-over (previously ldquoRolloverrdquo)

344 Falling objects

347 Transmission of power between self-propelled machinery (or tractor) and recipient machinery

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

36

Change in Essential Health and Safety Requirements ()

As for the exemption from the 2nd and 3rd paragraph of 1513 where the main function of the machinery is the spraying of products the text has been completed with the obligation of protecting the operator against the emissions

Addition of a requirement as follows ldquowhere necessary there must be an appropriate connection between a trailer and the machinery for the operation of signalsrdquo

3631 Vibrations (title added to this item that was previously numbered a))Concerning the information on vibrations to be given by the manufacturer we find here the following changes and new elementsThe values to be given become ldquothe vibration total value to which the hand-arm system is subjectedrdquoldquothe highest root mean square value of weighted acceleration to which the whole body is subjectedrdquoldquothe uncertainty of measurementrdquo must be givenAdditional rules for the measurement methods are formulated

353 Emissions of hazardous substances (previously ldquoEmissions of dust gases etcrdquo)

361 Signs signals and warnings (previously ldquoSigns and warningrdquo)

363 Instructions (previously ldquoInstruction handbookrdquo)

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

37

Change in Essential Health and Safety Requirements ()

New definitionsldquoLifting operationrdquoldquoCarrierrdquo

4128 Machinery serving fixed landings (New requirement previously very limited dealing with aspects concerning the extension of the scope of the Directive eg to construction site hoists slow moving lifts)41281 Movements of the carrier41282 Access to the carrier (including some elements from previous EHSR 423)41283 Risks due to contact with the moving carrier41284 Risks due to the load falling off the carrier41285 Landings

4 Supplementary EHSR to offset hazards due to lifting operations411 Definitions

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

38

Change in Essential Health and Safety Requirements ()

The previous requirement 424 applicable to powered lifting machinery has been relocated under ldquo41 Generalrdquo and is now applicable to all lifting machinery This is also confirmed by the reformulation including now a more explicit requirement that ldquoThe static and dynamic tests must be performed on all lifting machinery ready to be put into servicerdquo

Besides some other reformulation the term ldquonominal loadrdquo has been changed into ldquoworking loadrdquo

Additionally the instructions must give ldquothe static test coefficient usedrdquo

433 Lifting machinery (previously ldquoMachineryrdquo)

44 Instructions441 Lifting accessories

The information about the maximum working load is brought in line with the reformulation of EHSR 433Additional element in the instructions a record of the fitness for purpose testing ldquowhere appropriate a test report detailing the static and dynamic tests carried out by or for the manufacturer or his authorised representativerdquo

442 Lifting machinery (previously ldquoMachineryrdquo)

413 Fitness for purpose

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

39

Change in Essential Health and Safety Requirements ()

Old 53 LightingThis old EHSR containing an exception from the requirement of EHSR 114 concerning lighting of internal parts requiring frequent inspection and adjustment and of maintenance areas has been deleted

The old requirement on space and strength of the floor of the carrier is now extended to the complete ldquocarrier including any trapdoorsrdquoAdditional details in the requirements concerning the ldquosuspension or supporting systemrdquoIf ropes or chains are used an additional more explicit requirement for at least two independent ropes or chains each with their own anchorage

The exception from the obligation for a ldquohold-to-run control devicerdquo(previously called ldquomaintained command type control devicerdquo) applies now ldquowhere the carrier itself is completely enclosedrdquo (instead of ldquoin the case of machinery serving specific levelsrdquo) (old 621)

5 Suppl EHSR for machinery intended for underground work

6 Supplementary EHSR for machinery presenting particular hazards due to the lifting of persons611 Mechanical strength (previously ldquo612rdquo)

62 Control devices (previous 62)

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

40

Change in Essential Health and Safety Requirements ()

This ldquonewrdquo requirement corresponds practically to the old EHSR 623 and 642 (ldquoexcess speedsrdquo has been deleted)

A requirement has been added concerning the stability of the carrier and the prevention of dangerous movements when the carrier is designed as a work stationThe requirement of old EHSR 632 has been reformulated by adding the need for prevention of inadvertent opening of trapdoors

ldquoWhere there is a risk of objects falling on the carrier and endangering persons the carrier must be equipped with a protective roofrdquo

64 Machinery serving fixed landings (new)

Newrdquo 631 Risks due to movements of the carrier

632 Risk of persons falling from the carrier (previously ldquo63rdquo)

633 Risk due to objects falling on the carrier (new requirement)

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

41

Change in Essential Health and Safety Requirements ()

Precautions against contact of persons with fixed or moving elements If necessary the carrier shall be enclosed with interlocking doors with lockingMeasures and devices against uncontrolled upward or downward movements of the carrier Devices must be able to stop the carrier at maximum load and speedPrevention of harmful decelerations during stopping actions

Controls at the landings other than for emergency use shall not initiate movements when control devices in the carrier are operated or when the carrier is not at a landing

Guarding at the landings and on the carrier must ensure a safe transfer of goods and persons to and from the carrier

Additional requirement for including in the marking of the carrierldquothe number of persons permitted on the carrierrdquoldquothe maximum working loadrdquo

65 Markings

641 Risks to persons in or on the carrier

642 Controls at landings

643 Access to the carrier

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

42

Fixed guards

Something that will affect virtually all machine builders is thechange to the way fixed guards must be fastened to the machineFixings can no longer be loose the new Directive states that theymust remain attached to either the guards or machinery when theguards are removed

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

43

Conformity assessment

One of the key changes in the new Directive is the liberalisation of the conformity assessment procedures for some types of machinery (listed inAnnex IV) Manufactures can either request EC type-examination by a Notified Body or have a Notified Body approve a full quality assurancesystem covering design manufacture final inspection and testingThere are changes relating to the Technical File and Declaration ofConformity and a new Declaration of Incorporation of partly completed machinery

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

44

Market surveillance

The new Directive is more explicit about the duties of the MemberStates to organise market surveillance Obligations include cooperationbetween the market surveillance (enforcement) authorities and respect for confidentiality and transparency In addition the new Directive draws on material in General ProductSafety Directive enabling the European Commission to adopt adecision after consultation of the Machinery Committee to prohibitor restrict the placing on the market of a category of machinespresenting risks to health and safety due to shortcomings in therelevant harmonised standard(s) or by virtue of their technicalcharacteristics or to make such machinery subject to special conditions

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

45

Certification

Manufacturers that have obtained EC type-examination certificatesfor their machinery under the existing Directive will need to requesta review of the certification by the Notified Body as new certificates issued in accordance with the new Directive will need to be in place when the machinery is placed on the market after 29 December 2009For machinery certified in accordance with Article 8(2)(c) of the old Directive (ie Annex VI machinery for which a technical file has been sent to a Notified Body or a certificate of adequacy issued) manufacturers will need to apply one of the procedures from Article 12(3) and (4) of the newDirective as the old route to certification no longer exists in the new

Directive

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

46

Annex II - Declarations1 A EC Declaration of Conformity of the machineryThe EC Declaration of Conformity must now state the place and date of the declarationThe name and address of the person authorised to compile the technical file whomust be established in the Community

1 B Declaration of Incorporation of partly completed machineryThis is new as partly completed machinery was not part of the old Directives scopeNote that there is no longer a separate declaration of conformity for safety components

2 CustodyThere is a new requirement for the manufacturer of the machinery (or partly completed machinery) or his authorised representative to keep the original EC declaration of conformity (or declaration of incorporation) for at least 10 years from the last date of manufacture of the machinery (or partly completed machinery)

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

47

Annex III - CE marking

This Annex now states that the CE mark must be affixed in the immediate vicinity of the name of the manufacturer or his authorised representative using the same techniqueIn addition where the full quality assurance procedure referred to in Article 12(3)(c) and 12(4)(b) has been applied the CE marking must be followed by the notified bodys identification number

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

48

Annex IV - Categories of machinery to which one of theprocedures referred to in Article 12(3) and (4) must be applied

Some items are reworded for clarity but other more significantchanges are as followsbull Internal combustion engines for underground working are no longer listedbull Bimanual controls are no longer listedbull Logic units to ensure safety functions are now includedbull Portable cartridge-operated fixing and other impact machinery are now includedbull Machinery for the manufacture of pyrotechnics is no longer listed

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

49

Annex V - Indicative list of the safety components referred toin Article 2(c)

This new Annex includes some of the items from Annex IV (such as guards for removable mechanical transmission devices protective devices designed to detect the presence of persons roll-over protective structures and falling object protective structures) plus various types of guard valves extraction systems monitoring devices restraint systems energy limiters noisevibration reduction systems and various lift components Note that the list of items is indicative so other products can be defined as safety components by reference to Article 2(c) the list can also be updated by the Commission in accordance with Article 8(1)(a)

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

50

Annex VIIPart A - Technical file for machineryThe information contained in this new Annex was previously incorporated within the old Annex V EC Declaration of Conformity Note however that the new Directive states that the technical file must contain a general description of the machinery even though this is also required in the instructions a copy of which must be included in the technical fileWhereas the old Directive only implied that a copy of the risk assessment should be included in the technical file the new Directive states it explicitly The new Directive states that a copy of the EC Declaration of Conformity must be included in the technical file (the old Directive states that the technical construction file must be compiled before the Declaration of Conformity can be drawn up) For partly completed machinery the technical file must contain both the declaration of incorporation and the relevant assembly instructions In the case of series manufactured machinery the technical file must contain the internal measures that will be implemented to ensure that the machinery remains in conformity with the Directive

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

51

Part B - Relevant technical documentation for partlycompleted machinery

This part of the Annex is new and its contents are broadly similarto Part A

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

52

Annex VIII - Assessment of conformity with internal checks onthe manufacture of machinery

This new Annex relates to series machines In essence it statesthat for each machine a technical file shall be drawn up and themanufacturer must take all measures necessary to ensure that themanufactured machinery complies with the technical file

Annex IX - EC type-examinationThis new Annex is similar to the old Annex VI but section 92states that the manufacturer has the ongoing responsibility ofensuring that the said machinery meets the corresponding state ofthe artIn addition section 93 states that the manufacturer shall requestfrom the notified body the review of the validity of the EC type examinationcertificate every five years

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

53

Annex X - Full quality assurance

This new Annex describes the conformity assessment of Annex IVmachinery manufactured using a full quality assurance system and the procedure whereby a notified body assesses and approves the quality system and monitors its applicationThis has the potential to be a more cost-effective route to compliance than EC type-examination though whether or not this is the case will have to be determined by the manufacturer

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

54

Annex XI - Minimum criteria to be taken into account byMember States for the notification of bodies

This new Annex is very similar to the old Annex VII but there aretwo new sections Section 8 states that notified bodies shallparticipate in co-ordination activities and be involved directly orrepresented in the European standardisation process in order thatthey know the situation in respect of relevant standardsSection 9 states that Member States must take all necessary stepsto ensure that a notified bodys customer files are handed over toanother notified body or made available to the Member State in theevent of the notified body ceasing its activities

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

55

Thank you for your attention

Any question

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15726 EN 歐盟官方期刊 962006

第 1 條

範圍

1 本指令適用於下列產品

(a) 機器

(b) 可互換的設備

(c) 安全零組件

(d) 升降配件

(e) 鏈條繩索及帶子

(f) 可拆卸之機械傳動裝置

(g) 部分完成之機器

(1) 以規範 (EC) No 18822003 (OJ L 28431102003 p1) 修訂 OJ

L 213 791995 p1 指令 (2) OJ C 321 31122003 p1 (3) OJ L 184 177 1888 p23

2 下列項目不適用本指令

(a) 作為備用零件用以更換相同零組件且由機器原

廠供應之安全零組件

(b) 露天市集及或遊樂園的專用設備

(c) 在設計上專門用於核子用途且在故障時可能造

成輻射外洩的機器

(d) 武器包括火器

(e) 下列運輸工具

－ 為承受指令 200337EC 規定之風險而使用

農林牽引機但不包括安裝在車輛上的機

器

－ 1970年2月6日理事會指令70156EEC（有

關會員國針對機動車輛及其掛車之類型核

准的法律）規定之機動車輛及其掛車(1)但

不包括安裝在車輛及掛車上的機器

(1)以執委會指令 200628EC (OJ L 65732006 P27) 修訂 OJ L 42 2321970 P1 指令

－ 歐洲議會指令 200224EC 及 2002 年 3 月

18 日理事會指令（有關雙輪或三輪機動車

輛(2)之類型核准）規定之車輛但不包括安

裝在車輛上的機器

－ 僅為競標製造之機動車輛及

－ 運用空中水面及鐵路網之運輸工具但

不包括安裝在運輸工具上的機器

(f) 遠洋船舶及機動性近海船舶以及安裝在遠洋及

或近海船舶上的機器

(g) 專為軍用或警用目的所設計製造的機器

(h) 專為實驗室臨時研究之用而設計製造的機器

(i) 礦井捲揚式升降機

(j) 藝術表演時用來移動演出者的機器

(2)以執委會指令 200530EC (OJ L 1062742005 P17) 修訂 OJ L 124 952002 P1 指令

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15727 EN 歐盟官方期刊 962006

(k) 屬於下列領域之電氣和電子產品但以適用1973年 2 月 19 日理事會指令 7323EEC（有關在一

定電壓極限範圍(3)內使用電氣設備的會員國法

律條文）者為限

－ 僅供家務使用之家庭電氣用品

－ 音響設備

－ 資訊科技設備

－ 一般事務機器

－ 低電壓開關及控制設備

－ 電動馬達

(l) 以下類型之高壓電氣設備

－ 開關及控制設備

－ 變壓器

第 2 條

定義

為符合本指令之宗旨「機器」係指第 1 條(1)(a)至(f)所稱之產品

下列定義應予適用

(a) 「機器」係指

－ 已安裝或計劃安裝於驅動系統而非直接

施用人力或獸力之總成件該驅動系統包

含多個聯結零件或組件至少一個零件或

組件作動且各零件或組件係為特定用途

而相互連接

－ 上述第一項所稱之總成件但僅缺乏將其

連接至現場或能量及動力源之組件

－ 上述第一及第二項所稱之總成件已準備

好可隨時安裝且必須安裝在運輸工具

建築物或結構體才能發揮功能

－ 上述第一第二及第三項所稱之機器總成

件或(g)項所稱之部分完成之機器經安

排和控制後可發揮整合功能進而達成相

(3)以執委會指令 9368EEC (OJ L 2203081993 P17) 修訂 OJ L

77 2631973 P29指令

同目的

－ 聯結零件或組件之總成件其中至少有一

個零件或組件進行作動相互連接以舉升

裝載物且以直接施加人力作為動力的來

源

(b) 「可互換的設備」係指一種裝置在機器或牽引

機投入服務後即由作業員將其與該機器或牽引

機組裝在一起以改變其功能或賦予其新的功

能 但若此設備為一種工具即不適用此定義

(c) 「安全零組件」係指符合下列條件之零組件

－ 以發揮安全功能為目的

－ 可單獨在市場上銷售

－ 發生故障及或異常時會危及人員安全

且

－ 無需此零組件機器亦可發揮功能或者以

一般零組件替換後機器仍可發揮功能

附錄 V 提供一份安全零組件表內容得依第

8(1)(a)條而更新

(d) 「升降配件」係指未固定在升降機上可讓負載

獲得支撐放置在機器和負載之間或放置在負載

上或其目的在於構成負載整體的一部分且可

單獨在市場上銷售之組件或設備吊索及其組件

亦視為升降配件

(e) 「鏈條繩索及帶子」係指在設計和結構上用於

舉升目的屬於升降機或升降配件之一部分的鏈

條繩索及帶子

(f) 「可拆卸之機械傳動裝置」係指將自驅動機器或

掛車與另一機器連接於第一固定軸承藉此在連

接之兩機器間進行動力傳輸的可拆式組件 若此裝置連同護蓋上市銷售則應視為一種產品

(g) 「部分完成之機器」係指已幾乎組成機器但因

驅動系統僅部分完成而無法自行執行特定功能

的總成件 部分完成之機器僅會用於併入或裝

入其他機器或其他部分完成之機器或設備以組

成適用本指令之機器

(h) 「在市場上銷售」係指為經銷或使用目的首次

在歐盟境內推出之機器或部分完成之機器至於

是否取得價金或免費提供則非所問

(i) 「製造商」係指設計及或製造本指令規定之機

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15728 EN 歐盟官方期刊 962006

器或部分完成之機器的任何自然人或法人 機器或部分完成之機器將以製造商之名義或商標

在市場上銷售或是由製造商自行使用 製造

商應負責確保該機器或部分完成之機器符合本

指令之規定 若無任何製造商符合上述定義

則依本指令規定將機器或部分完成之機器上市

銷售或投入服務之任何自然人或法人皆視同本

指令所稱之製造商

(j) 「授權代表」係指接受製造商書面授權依本指

令規定為製造商履行全部或部分義務或完成全

部或部分手續之任何自然人或法人惟法人應以

在歐盟境內成立者為限

(k) 「投入服務」係指依預定用途首次在歐盟境內

使用本指令規定之機器

(l) 「調合標準（Harmonised standard）」係指由歐洲

標 準 化 委 員 會 （ European Committee for Standardisation CEN）歐洲電氣技術標準化委

員會（European Committee for Electrotechnical Standardisation CENELEC）或歐洲電信標準協

會 （ European Telecommunications Standards Institute ETSI）等標準化機構採用之一種無約束

力）的技術規範其採用係以歐盟執委會依歐洲

議會指令 9834EC規定之程序及 1998年 6月 22日之理事會指令（有關提供技術標準規範及資

訊社會服務領域相關資訊的程序）所發出的訓令

為依據(1)

第 3 條

特別指令

如其他歐盟指令對附錄 I 之全部或部分機器危險訂有

更詳盡之規定自該其他指令實施之日起本指令就

相關危險部分即不得再適用於該機器或應停止適用

第 4 條

市場監督

1 會員國應採取措施確保僅在符合本指令之相關

規定下以及於正確安裝保養及依預定用途或

在合理可預見之條件下使用時不會對人員的安

全衛生馴養之動物（若適用）或財產造成危害

(1)以 2003 加盟法修訂 OJ L 204 2171998 p 37指令

其後方可將機器上市銷售及或投入服務

2 2 會員國應採取所有措施確保僅在符合本

指令之相關規定時才能將部分完成之機器上市

銷售

3 會員國應成立或指定主管機關對機器及部分完

成之機器進行監督以確保符合第 1 及第 2 項之

規定

4 會員國應明定第 3 項主管機關之任務組織與權

責並將其規定及後續修訂內容通知歐盟執委會

和其他會員國

第 5 條

上市銷售及投入服務

1 機器上市銷售及或投入服務前製造商或其授

權代表應

(a) 確保機器符合附錄 I 之安全衛生相關規定

(b) 確保提供附錄 VII 第 A 篇所稱之技術檔案

(c) 尤其須提供如說明書等必要之資訊

(d) 依第 12 條規定正確完成符合性評估程序

(e) 依附錄 II 第 1 篇 A 節草擬 EC 符合聲明書（EC declaration of conformity）並確保隨機器提供

(f) 依第 16 條規定黏貼 CE 標誌

2 製造商或其授權代表應於部分已完成機器上市

之前完成第 13 條規定之程序

3 為符合第 12 條程序之宗旨製造商或其授權代

表應擬定或應有管道可採取必要之措施確保機

器符合附錄 I 中必要的安全衛生規定

4 若機器亦應適用其他指令中有關黏貼CE標誌和

其他項目的規定則 CE 標誌應指出機器亦符合

其他指令之相關規定

若一或多項指令允許製造商或其授權代表在過渡期間

選擇將適用之指令則 CE 標誌上僅可指出符合製造

商或其授權代表決定所適用的指令規定 製造商或其

授權代表應在 EC 符合聲明書中列明所選指令的詳細

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15729 EN 歐盟官方期刊 962006 內容且該指令應以歐盟官方期刊出版的指令為準

第 6 條

移動自由

1 會員國不得禁止限制或妨礙符合本指令之機器

在其國內上市銷售及或投入服務

2 如製造商或其授權之代表依附錄 II 第 1 篇 B 節

提出合併聲明書表示部分完成之機器將併入其

他機器或和其他部分完成之機器組裝而形成完

整之機器者會員國即不得禁止限制或妨礙該

部分完成機器之上市銷售

3 在商業博覽會商展展示或其他類似場合會

員國不得禁止展出不符合本指令之機器或部分

完成之機器但若有明顯跡象清楚指出其與本指

令不符且在符合本指令之規定前不會提供予使

用者則得禁止展出 在展出不符合之機器或

部分完成之機器期間應採取足夠的安全措施

確保人員安全

第 7 條

符合性推定與調合標準

1 會員國應將黏貼 CE 標誌且隨附 EC 符合聲明書

（內容詳見附錄 II 第 1 篇 A 節）之機器視為符

合本指令

2 依調合標準（相關參考文獻已於歐盟官方期刊出

版）製造之機器應推定為符合該調合標準之必

要安全衛生規定

3 歐盟執委會在歐盟官方期刊中列明調合標準的

參考文獻

4 會員國應採取相關措施在國家層級上賦予社會

夥伴之影響力使其能影響調合標準之研擬與監

督流程

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15730 EN 歐盟官方期刊 962006

第 8 條

特別措施

1 歐盟執委會得依第 22(3)條之程序採取相關措

施執行與下列項目有關之各項規定

(a) 更新附錄 V 有關第 2 條(c)之安全零組件表

(b) 限制第 9 條所稱機器之上市銷售

2 歐盟執委會得依第 22(2)條之規定採取與本指

令之執行及實務應用有關的任何措施包括依第

19(1)條規定採取措施確保會員國彼此間以及

與歐盟執委會之間的合作

第 9 條

處理潛在危險機器之特別措施

1 若歐盟執委會依第 10 條規定認為調合標準不

能完全滿足其本身及附錄 I 規定之必要安全衛

生需求且機器的技術特徵因該項調合標準的此

一瑕疵而產生風險時則執委會得依本條第 3

項採取措施要求會員國禁止或限制該機器上市

銷售或要求該機器適用相關特別條款之規定

若歐盟執委會依第 11 條之程序認為會員國採

取之措施係屬合法且機器因其技術上之特徵而

產生相同風險時則執委會得依本條第 3 項採取

措施要求會員國禁止或限制該機器上市銷售

或要求該機器適用相關特別條款之規定

2 任何會員國皆得要求執委會審查採取第 1 項措

施之必要性

3 於第 1 項之情形下執委會應就其將採取的措施

徵詢會員國及其他利害關係國之意見確保在歐

盟層級上對人員的安全衛生提供高度保護

執委會應依據徵詢結果依第 22(3)條之規定採取必要

的措施

第 10 條

調合標準之爭議程序

若會員國或歐盟執委會認為調合標準並不能完全滿足

其本身及附錄 I 規定之必要安全衛生需求則執委會

或會員國得檢具理由將此事提交依指令 9834EC 所

成立之委員會 委員會應於期限內表示意見不得延

遲執委會得依據委員會的意見決定是否出版不

出版附帶條件出版維持附帶條件維持或是撤

銷歐盟官方期刊中有關調合標準的參考文獻

第 11 條

保障條款

1 若會員國確信本指令規定之機器即使已黏貼 CE

標誌附隨 EC 符合聲明書且依其預定用途或

在合理可預見之條件下使用仍可能對人員的安

全衛生馴養之動物（若適用）或財產造成危害

則其得採取所有相關措施從市場撤回機器禁

止機器上市銷售及或投入服務或限制機器之

自由移動

2 會員國應將其採取之措施立即通知執委會和其

他會員國並述明決定的理由尤其應述明不符

合事項是否因下列因素所造成

(a) 不符合第 5(1)(a)條之規定

(b) 不當使用第 7(2)條之調合標準

(c) 調合標準本身具有第 7(2)條之瑕疵

3 執委會應立即與相關當事國諮商

執委會應在完成諮商後確認會員國採取的措施是否

適當合法並應將其決定傳遞給發起行動之會員國

其他會員國以及製造商或其授權代表

4 若第 1 項之措施係肇因於調合標準之瑕疵且發

起行動的會員國堅持其立場則執委會或會員國

即應啟動第 10 條之程序

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15731 EN 歐盟官方期刊 962006

5 機器不符規定卻黏貼 CE 標誌者負責的會員國

應對黏貼 CE 標誌的任何人採取相關措施並應

通知執委會執委會並應通知其他會員國

6 執委會應確保將程序的進度和結果通知會員國

第 12 條

評估機器符合性的程序

1 為了證明機器符合本指令規範製造商或授權代

表應適用 234 項所述之其中一種程序來評估

符合性

2 對於附錄 IV 未指稱之機器製造商及其授權代

表應依循附錄 VIII 的符合性評估程序以及機

器製造之內部檢查程序

3 若機器明列於附錄 IV依照第 7(2)條的調合標

準製造且這些標準涵蓋所有必要的安全衛生規

定則製造商及其授權代表應適用下列其中一種

程序

(a) 附錄 VIII 的符合性評估程序以及機器製造之內

部檢查程序

(b) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(c) 附錄 X 的完整品質保證程序

4 若機器明列於附錄 IV但未依第 7(2)條的調合

標準進行製造或僅部分符合該標準或調合標

準未涵蓋所有必要的安全衛生規定或該機器並

無適用的調合標準則製造商或其授權代表應適

用下列其中一種程序

(a) 附錄 IX 的 EC 類型驗證程序以及附錄 VIII 第

3 點的機器製造之內部檢查程序

(b) 附錄 X 的完整品質保證程序

第 13 條

部分完成之機器適用程序

1 部分完成之機器的製造商或其授權代表應先確

保下列事項方可上市銷售機器

(a) 備妥附錄 VII 第 B 篇規定的相關技術文件

(b) 備妥附錄 VI 規定的組裝說明書

(c) 制訂附錄 II 第 1 篇 B 節規定的合併聲明書

2 部分完成之機器在併入最終機器之前應隨附組

裝說明書及合併聲明書此等文件將成為機器技

術檔案的一部分

第 14 條

驗證機構

1 會員國在指定機構進行第 12(3)及(4)規定的上市

銷售符合性評估後應將指定之機構通知執委會

及其他會員國並告知確定的符合性評估程序

評估機構受託評估之機器類別以及執委會之前

發給各機構的識別號碼 會員國應將所有後續

修正內容通知執委會及其他會員國

2 會員國應確保定期監督驗證機構並確認這些機

構是否隨時符合附錄 XI 規定之標準驗證機構

應在要求下提供包括預算文件在內的所有相關

資訊以確保符合附錄 XI 之需求

3 會員國應依據附錄 XI 的標準評估將指定及已

指定的機構

4 執委會應在歐盟官方期刊中公布驗證機構的名

單識別號碼及任務以便提供參考 執委會

應確保持續更新此名單

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15732 EN 歐盟官方期刊 962006 5 機構符合相關調合標準之評估準則者應納入歐

盟官方期刊之參考文獻且應推定為符合相關標

準

6 若驗證機構發現製造商不符或不再符合本指令

的相關規定或發現不應向其頒發 EC 類型驗證

證書或品質保證系統核准書驗證機構應在考量

比例原則後述明詳細理由暫停或撤銷已頒發之

證書或核准書或是限制證明文件的用途惟製

造商已採取相關矯正措施並確保遵守前述規定

者得不適用前述處分規定如有暫停或撤銷證書

或核准書或限制其用途或事實證明主管機關有

介入之必要者驗證機構應依第 4 條規定通知主

管機關會員國應立即通知其他會員國及執委

會不得延遲此外亦應制定申訴程序

7 對於負責安排指定和監督會員國境內驗證機構

的主管機關執委會應訂定規範為主管機關和

驗證機構舉行經驗交流活動以協調本指令之統

一適用

8 會員國在指定機構後如發現有下列情事應立即

撤銷指定

(a) 該機構不再符合附錄 XI 的標準或

(b) 該機構怠忽職責且情節重大

會員國應依此立即通知執委會與其他會員國

第 15 條

安裝與使用機器

如會員國認為有必要制定規範確保人員（尤其是工

人）在使用機器時受到保護則在不違反歐盟法律之

前提下本指令不得影響會員國制定相關規範之權

利惟此並不表示該機器係依據本指令以外之其他方

法改裝過

第 16 條

CE 標誌

1 CE 符合性標誌應包含以「CE」為開頭的字樣

如附錄 III 所示

2 應依據附錄 III 將 CE 標誌黏貼於機器上易於目

視讀取且不會遭到清除的位置

3 禁止在機器上黏貼可能對CE標誌之意義及或

形式方面造成第三方誤解的任何其他標誌標示

或描述若欲在機器上黏貼其他任何標誌該等

標誌不得影響CE標誌的可視性可讀性及涵義

第 17 條

不符合標準之標誌

1 會員國應將下列標誌視為不符合規定

(a) 產品不適用本指令但卻放置本指令規定之 CE標誌

(b) 機器上沒有CE標誌及或沒有能證明機器符合

性的 EC 聲明

(c) 在機器上放置第 16(3)條所禁止的其他標誌而

非 CE 標誌

2 會員國證實標誌不符合本指令的相關規定時製

造商或其授權代表有義務在會員國指定的條件

下使產品符合規定並終止侵權之行為

3 若依舊不符合規定會員國應依據第 11 條規定

之程序採取所有相關措施限制或禁止相關產品

上市銷售或確保從市場撤回產品

第 18 條

機密性

1 在不影響有關機密性之現有國家規範及實務

下會員國應確保其與執行本指令的所有相關當

事人及人員皆會將執行任務時所取得的資訊視

為機密 特別是商業專業及交易祕密尤應

視為機密 惟為保護人員安全衛生而必須洩漏

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15733 EN 歐盟官方期刊 962006

此類資訊者得不適用前述之規定

2 第 1 項之規定不得影響會員國及驗證機構之間

的資訊交流與發布警訊的義務

3 應公布會員國或執委會依據第 9 及第 11 條規定

所達成的所有決議

第 19 條

會員國彼此合作

1 會員國應採取相關措施確保第 4(3)條之主管機

關彼此之間以及與執委會之間能協同合作並相

互傳送必要之資訊以確保在一致的基礎上適用

本指令

2 執委會應訂定規範為負責市場監督的主管機關

舉行經驗交流活動以協調本指令之統一適用

第 20 條

法定救濟

依據本指令之規定對適用本指令之機器採取措施

限制其上市銷售及或投入服務者皆應述明其理

由並立即將該等措施通知相關當事人 前述通知應

包括當事人依會員國現行法得採取之法律救濟手段

以及各救濟手段之消滅時效

第 21 條

資訊的傳播

執委會應採取必要措施讓相關人員取得執行本指令

所需的相關資訊

第 22 條

委員會

1 歐盟執委會應設有一委員會（以下簡稱「委員

會」）提供協助

2 凡提及本條文者應適用 1999468EC 決議第 3

及第 7 條並參照第 8 條之規定

3 凡提及本條文者應適用 1999468EC 決議第 5及第 7 條並參照第 8 條之規定

1999468EC 決議第 5(6)條中所述之期限應設定為三

個月

4 委員會應採用其程序規定

第 23 條

懲罰

會員國應針對為執行本指令而制定的國內法就違法

行為制定罰則並採取所有必要之措施以確保實施

所制定之罰則應為有效符合比例原則且具有阻嚇性 會員國應於 2008 年 6 月 29 日前將罰則通知執委會

若有修改亦應立即通知不得遲延

第 24 條

指令 9516EC 的修訂

指令 9516EC 修訂如下

1 第 1 條的第 23 項應以下列條文取代

2 「為符合本指令之宗旨『升降機』係指可

舉升至一明確高度的升降設備附有載具沿

著導軌移動而導軌係由堅硬材質製成且

相對於水平面傾斜 15 度以上此機器可用

來輸送以下項目

mdash 人員

mdash 人員及貨物

mdash 單純貨物（若可出入載具）亦即人員可輕

鬆進入載具且控制器係安裝在載具內部

或是設於載具內部人員可取得的位置

沿著固定路線的升降設備即使無剛性導軌亦應

視為本指令規定之升降機

「載具」係升降機的一部分可用來承載人員及

或貨物進行升起或下降

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf

L 15734 EN 歐盟官方期刊 962006

3 本指令不適用於下列項目

mdash 速度低於 015ms 的升降設備

mdash 建築工地的起重機

mdash 空中索道包括纜線軌道

mdash 專為軍用或警用目的而設計的升降機

mdash 可直接在機器上執行任務的升降設備

mdash 礦井捲揚式升降機

mdash 藝術表演中吊起演出者的升降設備

mdash 安裝在運輸工具上的升降設備

mdash 連接機器且專門用來進出工作站（包括機

器上的維修及檢查點）的升降設備

mdash 齒條及小齒輪傳動系統

mdash 電扶梯及機械式通道

2 附錄 I 的第 12 點應以下列條文取代

12 「載具」

所有升降設備的載具應為吊艙此吊艙在

設計及結構上所提供的空間及強度應符合

安裝廠商設定的升降設備之最大承載人數

及額定負重

升降設備若用來運輸人員且尺寸許可其

吊艙的設計及結構特性不得妨礙或影響殘

障人士進出或使用並應能使這些人員進

行適當調整以利使用

第 25 條

廢除

指令 9837EC 茲此廢除

若參考資料指示參閱的指令現已廢除則視為其應參

閱本指令並依據附錄 XII 的關聯表參閱

第 26 條

過渡期

1 會員國應在 2008年 6月 29日前制訂並公布符合

本指令之規範並立即通知歐盟執行委員會

會員國應從 2009年 12 月 29日起實施這些規範

會員國採用這些規範時應在參考資料中納入本

指令或在官方出版物的參考資料中加入這些規

範會員國應決定參閱資料的方法

2 會員國應將符合本指令的國內法條文呈報歐盟

執行委員會並附表指出本指令規定與國內法規

定之間的相符關係

第 27 條

法律限制

會員國在 2011 年 6 月 29 日之前仍可將符合國內法

的可攜帶匣式定型機和其他衝擊機上市銷售與投入服

務惟該國內法應於採用本指令時有效

第 28 條

生效

本指令在歐盟官方期刊內公布後第 20 天開始生效

第 29 條

收件人

本指令應寄至各會員國

2006 年 5 月 17 日於 Strasbourg 完成制訂

歐洲議會 歐盟理事會

主席 主席

J BORRELL FONTELLES H WINKLER

• 1-1石緯杰-TUV NORD 新機械指令introduction 1pdf
• 1-2石緯杰-2006-42-EC 新版機器指令摘譯 - _0603_pdf