기업명 :

발표자 :

Robot

Regulatory requirement in EU

DNVGL BA Korea

이장섭jang.sup.lee@dnvgl.com

1

DNV GL GROUP

2

OIL & GASMARITIME ENERGY BUSINESS

ASSURANCE

SOFTWARE

RESEARCH & INNOVATION

CYBERNETICS

Global Network

3

400offices

100countries

16,000employees

150years

▪ 1864년 노르웨이 오슬로 설립▪ 2013년 독일 GL과 합병▪ 그룹본사 : 노르웨이 오슬로 위치▪ 인증 본사 : 영국 런던 위치

인증 & 검증(Certification & Verification)

교육훈련(Training)

평가(Assessment)

SUSTAINABLE BUSINESS PERFORMANCE

DNV GL Business Assurance

지속가능 자문(Sustainability Advisory)

산업별 특별 서비스(Industry specific services)

4

글로벌 인증기관

5

Top 4세계 4대 T.I.C 기관(매출기준)

Top 3세계 3대 인증기관(매출기준)

People전세계 2,000여명의 전문가네트워크 보유

Partnership전세계 180개국에서 70,000 여 고객사와 파트너십 보유

80,00080개 이상의 인정기구의승인을 받은 80,000여 개의경영시스템 인증

국내 인증기관 평가

6

1st

국내외 인증기관 중 최다우수심사원상 9회 수상

1st

2017년 6월 기준 해외 유명인증기관 중 ISO 9001,ISO 14001, OHSAS 18001 최다 인증 발행

AAA2008~2014년 인증기관평가에서 해외 유명 인증기관중최다 최우수 인증기관 평가

7

EU Product Directive

▪ A Law of the EU that must be implemented by all EEA member states. The

Directive is binding upon the member state as to the objective to be achieved,

with limited leeway as to how to achieve it.

▪ Intended to remove technical trade barriers by establishing a commonly

accepted level of safety.

8

EU Product Directive

▪ European Community (EC):

▪ European Economic Area (EEA):

▪ European Union (EU)

▪ European Land Transport Agreement (LTA)

▪ European Mutual Recognition Agreement (MRA)

▪ 28 EU Countries + Norway, Liechtenstein, Switzerland, Turkey

Machinery

Directive

2006/42/EC

Pressure Equipment Directive

2014/68/EU

ATEX

Directive

2014/34/EU

EMC

Directive

2004/30/EU

Low Voltage

Directive

2014/35/EU

0434

Related EU Directives

Others

Slide 11

• ‘Notified’ by the National or Competent Authority of an EEA member state, for a particular Directive

• National authorities are not obliged, under Community law, to notify all bodies who apply.

• Must remain third parties

• Must remain independent of their clients and other interested parties

• Accreditation of Notified Body is not a requirement (certificates contribute to presumption of conformity through EN 45001)

Notified Body

The marking CE, denoting:

“Communautés Européennes”

confirms that a product complies

with all relevant EU Product Directives except;

CE marking

Interoperability Directive, MED which do not bear CE mark

Covers all machines defined as: “ an assembly of linked parts, at least one of which moves, including actuators and control circuits, for the processing , package, moving of a material”

Machine must be powered by external energy source, i.e. electrical, hydraulic, pneumatic, weight, spring, etc.

▪ Main Directive for most robots but do not require NoBo certificate/involvement for DoC (Declaration of Conformity) by Directive itself.

▪ Some suppliers abuse this self-DoC scheme without full compliance.

▪ Not easy for yard to inspect DoC for all supplied equipment.

– 500 more EN harmonized standard under Machinery Directive

Machinery Directive 2006/42/EC

MD DoC Route

Robot per purpose

• Robot

– Actuated mechanism programmable in two or more axes with a degree of autonomy moving within its environment, to perform intended tasks.

• Industrial robot

– Automatically controlled, reprogrammable multipurpose manipulator, programmable in three or more axes, which can be either fixed in place or mobile for use in industrial automation applications

• Service robot

– Robot that performs useful tasks for humans or equipment excluding industrial automation applications

14

Industrial robot

• Industrial robot

– The manipulator, including actuators

– The controller, including teach pendant and any communication interface (hardware and software)

– Hand-guided robots

– The manipulating portions of mobile robots

– Collaborating robots

15

Personnel care robot

Personnel care robot is Service Robot that performs

actions contributing directly towards improvement in the quality of life of humans, excluding medial applications

•Mobile servant robot

– Personnel care robot that is capable of travelling to perform serving tasks in interaction with humans, such as handling objects or exchanging information

•Physical assistance robot

– Personnel care robot that physically assists a user to

perform required tasks by providing supplementation or augmentation of personnel capabilities

•Person carrier robot

– Personnel care robot with purpose of transporting

humans to an intended destination

16

Standards

• Industrial robot – EN ISO 10218-1, -2

– Does not apply to non-industrial robots, although the safety principles established in ISO 10218 can be utilized for these other robots.

– Examples of non-industrial robot applications include, but are not limited to, undersea, military and space robots, tele-operated manipulators, prosthetics and other aids for the physically impaired, micro-robots (displacement less than 1 mm), surgery or healthcare, and service or consumer products.

17

ISO/TS 15066 Collaborating robot

Safety-rated monitored stopHand guidingSpeed and separation monitoring

*Minimum separation distanceAnd Power and force limiting

*Biomechanical limits

Standards

• Personal care robot – EN ISO 13482:2014

Does not apply to

–Faster than 20km/h

–Robot toys

–Water-borne and flying robots

–Industrial robots

–Robots as medical devices

–Military and public forces application

18

Robotic battery powered electrical lawnmowers

EN 50636-2-107:2015 - Safety of household and similar appliances - Part 2-107: Particular requirements same with IEC 60335-2-107:2012

EU approach

• Machinery Directive 2006/42/EC covers both industrial and personnel care robots

• Type A, B and C standards

19

Type A

Type B

Type C

basic safety standards – Risk Assessment & Reduction

safety distance protective device

electrical safety pneumatic safety guards

machine safety

Functional Safetynoise

EHSRs

EN ISO 12100

EN ISO 14120,EN ISO 13849, others

EN ISO 10218EN ISO 13482

Example Type A, B and C standards

20

All directives have to be applied in parallel

▪ In principal if a product is within the scope of other directives at the same time, all directives have to be applied in parallel to fulfill the provisions of each directive.

0434EuP replaced by 2009/125/EC

CE marking step

STEP 1 – Identify the directive(s) and harmonised standards applicable to the product.

▪There are more than 20 directives setting out the product categories requiring CE marking.

▪The essential requirements that products have to fulfill (e.g. safety)

STEP 2 – Verify the product-specific requirements

▪Full compliance of a product to the harmonised standards gives a product the “presumption of conformity”with the relevant essential requirements.

▪The use of harmonised standards remains voluntary.

STEP 3 – Identify whether an independent conformity assessment is required from a NoBo

▪Each directive covering your product specifies whether an authorised third party (Notified Body)must be involved in the conformity assessment procedure necessary for CE marking

STEP 4 – Test the product and check its conformity

▪Testing the product and checking its conformity to the EU legislation (Conformity Assessment Procedure) is the responsibility of the manufacturer.

STEP 5 – Draw up and keep available the required technical documentation

STEP 6 – Affixation of the CE marking to your product and EC Declaration of Conformity

Safety related control system – Functional Safety

23

• Freedom from unacceptable risk – IEC 61058

• Avoid Systematic Failure – SW and Process

• Reduce Random Hardware Fault to acceptable level – HW

• Dealing with SIL, PL, ASIL

• PL is popular in the robot world

Functional Safety in Robot

24

Safety of Machinery Application independent

EN ISO 12100

Safety of machinery General principles for design

Risk assessment and risk reduction

EN ISO 13849-1

Safety of machinery

Safety-related parts of control systems Part 1: General principles for design

EN IEC 62061

Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems

IEC 61508

Functional safety of electrical/electronic/programmable electronic safety-related systems

compatible

Functional Safety

25

Term MIL-STD-882DIEC61508, IEC61511,

ISO13489EN50129/EN51028 ISO26262

Safety

Freedom from those conditions that can cause death, injury,occupational illness, damage to or loss of equipment or property, or damage to the environment.

freedom from unacceptable risk

freedom from unacceptable levels of risk of harm

absence of unreasonable risk

Hazard

Any real or potential condition that can cause injury, illness, or death to personnel; damage to or loss of a system, equipment or property; ordamage to the environment

potential source of harm a condition that could lead to an accident

potential source of harm caused by malfunctioning behaviour of the item

Harm Not specified.

physical injury or damage to the health of people or damage to property or the environment

Not specified.

physical injury or damage to health of persons

Risk Not specified.

combination of the probability of occurrence of harm and the severity of that harm

the combination of the frequency, or probability, and the consequence of a specified hazardous event

combination of the probability of occurrence of harm and the severity of that harm

IEC 62061 and ISO 13849-1

26

Technology implementing the safety-related control function(s)

ISO 13849-1 IEC 62061

A Non-electrical, e.g. hydraulics X Not covered

B Electromechanical, e.g. relays, and/or non complex electronics

Restricted to designated architectures a

and up to PL = eAll architectures and up to SIL 3

C Complex electronics, e.g. programmable

Restricted to designated architectures a

and up to PL = dAll architectures and up to SIL 3

D A combined with B Restricted to designated architectures a

and up to PL = eX c

E C combined with B Restricted to designated architectures (see Note 1) and up to PL = d

All architectures and up to SIL 3

F C combined with A, or C combined with A and B

X b X c

X indicates that this item is dealt with by the International Standard shown in the column heading.

a Designated architectures are defined in 6.2 in order to give a simplified approach for quantification of performance level.b For complex electronics: use designated architectures according to this part of ISO 13849 up to PL = d or any architecture according to IEC 62061.c For non-electrical technology, use parts in accordance with this part of ISO 13849 as subsystems.

27

Safety functions and PLs in the standards

• Industrial robot– EN ISO 10218-1 requires PL D and category 3 structure (shall be applied to cooperative robots)

• Major safety functions with PL D

- Emergency stop

- Protective stop (Comm. loss, enabling device input, mode change, etc)

- Speed control (monitoring, reducing, reduced when Teaching, etc)

- Singularity protection (warning, reducing speed =<250mm/s)

- Power limit, momentum limit, torque limit, position limit, etc

• General robot controls example