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DDD 38 2018 2018-09-17 Page 1

CEN System - Delegated Decisions Dispatch 38:2018

1 CEN/TC 127 ............................................................................................................................. 1 2 CEN/TC 140 ............................................................................................................................. 2 3 CEN/TC 149 ........................................................................................................................... 10 4 CEN/TC 152 ........................................................................................................................... 10 5 CEN/TC 180 ........................................................................................................................... 11 6 CEN/TC 203 ........................................................................................................................... 11 7 CEN/TC 216 ........................................................................................................................... 12 8 CEN/TC 230 ........................................................................................................................... 16 9 CEN/TC 286 ........................................................................................................................... 29 10 CEN/TC 305 ........................................................................................................................... 32 11 CEN/TC 339 ........................................................................................................................... 36 12 CEN/TC 441 ........................................................................................................................... 38 13 CEN/TC 458 ........................................................................................................................... 39 14 CEN/TC 350 ........................................................................................................................... 39

1 CEN/TC 127 DECISION 985 taken by CEN/TC 127 on 2018-08-30 Subject: CEN/TC 127 - Appointment of Chairperson The CEN/TC 127 'Fire safety in buildings',

- considering the CEN/CENELEC Internal Regulations - Part 2, subclause 3.2.2, which lays down the rules for nomination, appointment and responsibilities of Chairpersons;

- noting the nomination by the Technical Committee Secretariat; - noting the commitment of the applicant to the responsibilities and duties of a

Technical Committee Chairperson as given in the CEN BOSS; (Option 1 ) decides to appoint name of person as Chairperson of CEN/TC number for a period of number of years years starting on CCYY-MM-DD. (Option 2 ) decides to re-appoint Debbie Smith, as Chairman of CEN/TC 127 for a period of 3 years starting on 2018-11-10, noting that Debbie Smith is Chairperson of the Technical Committee since 2009-11-10. The decision was taken by unanimity.

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2 CEN/TC 140 Decision CEN/TC 140 24/2018 taken on 2018-08-15

Subject: Adoption of a Preliminary Work Item

CEN/TC 140 In vitro diagnostic medical devices

Secretariat: DIN Proposal documented in N 1200

1. Deliverable TS

2. This item corresponds to A new project

3. Explain the purpose and give a justification for this proposal Molecular in vitro diagnostics has enabled a significant progress in medicine. Further progress is expected by new technologies analyzing profiles of nucleic acids, proteins, and metabolites in human tissues and body fluids. However, the profiles of These molecules can change drastically during the pre-examination process, including the specimen collection, transport, storage and processing. Consequently, this makes the outcome from diagnostics or research unreliable or even impossible because the subsequent examination might not determine the real situation in the patient but an artificial profile generated during the pre-examination processes. Besides cell free circulating nucleic acids, circulating tumour cells (CTCs) and other rare cells, exosomes and other extracellular vesicles represent another key component of liquid biopsies. There is therefore a strongly increasing interest in research and emerging diagnostics in exosomes and other extracellular vesicles. The pre-examination process described in this document results in isolated RNA, DNA and proteins from enriched exosomes and other extracellular vesicles. New additional exosomes can be formed and existing exosomes can be lost after blood collection, thus changing the overall exosome RNA/DNA/protein profile. Also different anticoagulants can influence the release of exosomes from different cells present in blood, including those being derived from platelets. Several additional factors can also influence the post collection changes of the entire blood exosome composition. These include the presence of drugs, physical exercise as well as pre-analytical variables (temperature, centrifugation, tubes, etc.).

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Standardization of the entire workflow from venous whole blood collection to the RNA, DNA and protein examination from exosomes and other extracellular vesicles is therefore needed. Studies have been undertaken to determine the important influencing factors. This document draws upon such work to codify and standardize the steps of RNA, DNA and protein examination from exosomes and other extracellular vesicles in what is referred to as the pre-examination phase. RNA, DNA and protein examination from exosomes and other extracellular vesicles belongs to a strongly growing application field of liquid biopsies. For example, exosome examinations count for about 2% of all liquid biopsies analysis showing a high double digit growth rate. This document will contribute to an entire molecular diagnostics and research market for exosomes/ccfRNA of more than US$ 112.000.000/year by 2021. The compound annual growth rate (CAGR) is expected to be 47% from 2016 to 2021. [Exosomes Diagnostics and Therapeutics: Global Markets, 2016].

4. Stakeholder categories immediately affected by the proposal Industry and commerce Standards application SMEs Non-governmental organization (NGO) Government Academic and research bodies Consumers

5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? Biomedical research including the diagnostic and pharmaceutical industry is heavily affected by pre-analytical variables, thus “limiting at least performance and safety of products and services”, but also innovation and progress in industry and academic research. Studies indicate that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28B/year being wasted on preclinical research that is not reproducible - in the USA alone. Samples, biological reagents and reference material, as one category of errors, contribute to this by about 36% (Freedman et al., 2015). Although it is probably impossible to eliminate all pre-analytical errors, “compliance with harmonized pan-European and International Standards documents and accompanying Quality Assurance Schemes can significantly reduce their incidence”, as demonstrated by the SPIDIA Consortium (e.g. Malentacchi F. et al., PLoS One. 2014-11); The pre-analytical phase accounts for 46% to 68% of the errors observed during the diagnostic examination process (Medical Laboratory Observer (MLO), 2014-05). The pre-analytical phase thus remains the most error-prone part of laboratory testing (MLO, 2014-05). On average, pre-analytical errors costs represent between 0.23% and 1.2% of total hospital operating costs. This unnecessary expenditure can be extrapolated to a typical U.S. hospital with approximately 650 beds to US$1.2M/year (Green SF. Clin Biochem. 2013). Similar numbers are estimated for European hospitals (e.g. Frost & Sullivan 2011). This new TS will become part of a broad already running initiative of CEN and ISO documents addressing the pre-examination phase thus becoming a key contribution to improve the numbers shown above. This TS is of specific importance as it addresses a fast growing research and diagnostic field of tissue biopsies for industries, incl. SMEs, pharmaceutical/biotechnology and IVD companies as well as for academic research and biobanks.

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6. Document developed in drafting body Existing drafting body

7. Title Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood — Isolated RNA, DNA and proteins

8. Scope This document specifies requirements and recommendations for the pre-examination phase for RNA, DNA and protein examination from exosomes and other extracellular vesicles from venous whole blood collection. The pre-examination phase includes but is not limited to specimen collection, handling, storage, processing and documentation. The pre-examination process described in this document results in isolated RNA, DNA and proteins from enriched exosomes and other extracellular vesicles. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures need to be taken during the pre-examination phase for venous whole blood circulating cell free RNA (ccfRNA) examination without prior enrichment of exosomes and other extracellular vesicles. These are not described in this document but are covered in CEN/PWI Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Isolated circulating cell free RNA from plasma. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

9. Proposed Project Leader (including contact details) - optional Kalle Guenther ([email protected]), Uwe Oelmueller ([email protected])

10. Accessibility aspects Accessibility aspect are not relevant for this NWI. There is no issue for handicapped people to use this standard. By this standard addressed institutions and so forth which are usually easily accessible by handicapped people.

11. Environmental aspects None of the above This new standard addresses human specimen by improving their qualities. These will result in a reduction of errors in diagnostics and research. Patients will benefit from this error reduction by improved diagnosis and treatment, resulting in better disease outcome. This does not lead to any impacts to the above mentioned environmental aspects.

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12. How do you plan to address these environmental aspects? OtherDoes not need to be addressed as no impacts are described in 11.

13. Link with European Research and/or Innovation project Yes Research and/or Innovation project code:733112 (Horizon2020 program) Research and/or Innovation project acronym:SPIDIA4P Research and/ or Innovation project title:SPIDIA for Personalized Medicine - Standardisation of generic Pre-analytical procedures for In vitro diagnostics for Personalized Medicine

14. Track Vote on TS/TR by correspondence

15. Please provide the target date for the below key stage Activation of the preliminary WI (10.90): 2019-10-15

16. Related standardization request(s) (formely mandate) No

17. Related directive(s)/regulation(s) No

18. Relation to other legislation or established public policy. Yes REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, e.g. Annex II, 6.1. Information on analytical performance of the device, 6.1.1. Specimen type: This Section shall describe the different specimen types that can be analysed, including their stability such as storage, where applicable specimen transport conditions and, with a view to time-critical analysis methods, information on the timeframe between taking the specimen and its analysis and storage conditions such as duration, temperature limits and freeze/thaw cycles.

19. Is the proposed project covered by Intellectual Property Rights (IPR)? No

20. The decision was taken by Simple majority Number of positive votes: 13 Number of negative votes: 0 Number of abstentions: 10

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Decision CEN/TC 140 25/2018 taken on 2018-08-15


CEN/TC 140 In vitro diagnostic medical devices


1. Deliverable TS


3. Explain the purpose and give a justification for this proposal Molecular in vitro diagnostics has enabled a significant progress in medicine. Further progress is expected by new technologies analyzing profiles of nucleic acids, proteins, and metabolites in human tissues and body fluids. However, the profiles of these molecules can change drastically during the pre-examination process, including the specimen collection, transport, storage and processing. Consequently, this makes the outcome from diagnostics or research unreliable or even impossible because the subsequent examination might not determine the real situation in the patient but an artificial profile generated during the pre-examination processes. Besides cell free circulating DNA, circulating tumour cells (CTCs) and other rare cells, cell free circulating RNA (ccfRNA) represents another key component of liquid biopsies. There is therefore a strongly increasing interest in research and emerging diagnostics in cell free circulating RNA. In blood, ccfRNA is composed of extracellular RNA present in and/or outside of exosomes and other extracellular vesicles. The pre-examination process described in this document results in cell free circulating RNA (ccfRNA) isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles. ccfRNA profiles can change significantly after blood collection (e.g., release and/or loss of RNA containing exosomes and other extracellular vesicles, ccfRNA degradation and ccfRNA quantity change). Therefore, special measures have to be taken to secure good quality specimens for ccfRNA examination. Standardization of the entire workflow from specimen collection to the ccfRNA examination is therefore needed. Studies have been undertaken to determine the important influencing factors. This document draws upon such work to codify and standardize the steps of ccfRNA examination in what is referred to as the pre-examination phase. ccfRNA examination belongs to a strongly growing application field of liquid biopsies.

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This document will contribute to an entire molecular diagnostics and research market for exosomes/ccfRNA of more than US$ 112.000.000/year by 2021. The compound annual growth rate (CAGR) is expected to be 47% from 2016 to 2021. [Exosomes Diagnostics and Therapeutics: Global Markets, 2016].

4. Stakeholder categories immediately affected by the proposal Industry and commerce Standards application SMEs Non-governmental organization (NGO) Government Academic and research bodies Consumers

5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? Biomedical research including the diagnostic and pharmaceutical industry is heavily affected by pre-analytical variables, thus “limiting at least performance and safety of products and services”, but also innovation and progress in industry and academic research. Studies indicate that the cumulative (total) prevalence of irreproducible preclinical research exceeds 50%, resulting in approximately US$28B/year being wasted on preclinical research that is not reproducible - in the USA alone. Samples, biological reagents and reference material, as one category of errors, contribute to this by about 36% (Freedman et al., 2015). Although it is probably impossible to eliminate all pre-analytical errors, “compliance with harmonized pan-European and International Standards documents and accompanying Quality Assurance Schemes can significantly reduce their incidence”, as demonstrated by the SPIDIA Consortium (e.g. Malentacchi F. et al., PLoS One. 2014-11); The pre-analytical phase accounts for 46% to 68% of the errors observed during the diagnostic examination process (Medical Laboratory Observer (MLO), 2014-05). The pre-analytical phase thus remains the most error-prone part of laboratory testing (MLO, 2014-05). On average, pre-analytical errors costs represent between 0.23% and 1.2% of total hospital operating costs. This unnecessary expenditure can be extrapolated to a typical U.S. hospital with approximately 650 beds to US$1.2M/year (Green SF. Clin Biochem. 2013). Similar numbers are estimated for European hospitals (e.g. Frost & Sullivan 2011). This new TS will become part of a broad already running initiative of CEN and ISO documents addressing the pre-examination phase thus becoming a key contribution to improve the numbers shown above. This TS is of specific importance as it addresses a fast growing research and diagnostic field of tissue biopsies for industries, incl. SMEs, pharmaceutical/biotechnology and IVD companies as well as for academic research and biobanks.

6. Document developed in drafting body Existing drafting body

7. Title Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Isolated circulating cell free RNA from plasma

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8. Scope This document recommends the handling, storage, processing and documentation of venous whole blood specimens intended for circulating cell free RNA (ccfRNA) examination during the pre-examination phase before a molecular assay is performed. This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in cell free circulating RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles. These are not described in this document but are covered in CEN/PWI Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood — Isolated RNA, DNA and proteins. Different dedicated measures need to be taken for stabilizing blood cellular RNA, which are not described in this document. Blood cellular RNA is covered in ISO 20186-1, Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for venous whole blood — Part 1: Isolated cellular RNA. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

9. Proposed Project Leader (including contact details) - optional Kalle Guenther ([email protected]), Uwe Oelmueller ([email protected])

10. Accessibility aspects Accessibility aspect are not relevant for this NWI. There is no issue for handicapped people to use this standard. By this standard addressed institutions and so forth which are usually easily accessible by handicapped people.

11. Environmental aspects None of the above This new standard addresses human specimen by improving their qualities. These will result in a reduction of errors in diagnostics and research. Patients will benefit from this error reduction by improved diagnosis and treatment, resulting in better disease outcome. This does not lead to any impacts to the above mentioned environmental aspects.

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12. How do you plan to address these environmental aspects? OtherDoes not need to be addressed as no impacts are described in 11.

13. Link with European Research and/or Innovation project Yes Research and/or Innovation project code:733112 (Horizon2020 program) Research and/or Innovation project acronym:SPIDIA4P Research and/ or Innovation project title:SPIDIA for Personalized Medicine - Standardisation of generic Pre-analytical procedures for In vitro diagnostics for Personalized Medicine

14. Track Vote on TS/TR by correspondence




18. Relation to other legislation or established public policy. Yes REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, e.g. Annex II, 6.1. Information on analytical performance of the device, 6.1.1. Specimen type: This Section shall describe the different specimen types that can be analysed, including their stability such as storage, where applicable specimen transport conditions and, with a view to time-critical analysis methods, information on the timeframe between taking the specimen and its analysis and storage conditions such as duration, temperature limits and freeze/thaw cycles.



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3 CEN/TC 149 DECISION 02/2018 taken by CEN/TC 149 on 2018-08-29 Subject: CEN/TC 149 "Power-operated warehouse equipment" - Appointment of Chairperson The CEN/TC 149, - considering the CEN/CENELEC Internal Regulations - Part 2, subclause 3.2.2, which lays down the rules for nomination, appointment and responsibilities of Chairpersons; - noting the nomination by the Technical Committee Secretariat; - noting the commitment of the applicant to the responsibilities and duties of a Technical Committee Chairperson as given in the CEN BOSS; (Option 1 X) decides to appoint Prof. Dr.-Ing. habil. Thorsten Schmidt as Chairperson of CEN/TC 149 for a period of 3 years starting on 2019-01-16. (Option 2 ) decides to re-appoint name of person, as Chairman of CEN/TC number for a period of number of years years starting on CCYY-MM-DD , noting that name of person is Chairperson of the Technical Committee since CCYY-MM-DD. The decision was taken by simple majority with 10 positive votes, 0 negative votes and 9 abstentions.

4 CEN/TC 152 DECISION N 75 taken by CEN/TC 152 on 2018-08-31 Subject: CEN/TC 152 – Re-Appointment of Chairperson The CEN/TC 152 Fairground and amusement park machinery and structures - Safety,

- considering the CEN/CENELEC Internal Regulations - Part 2, subclause 3.2.2, which lays down the rules for nomination, appointment and responsibilities of Chairpersons;

- noting the nomination by the Technical Committee Secretariat; - noting the commitment of the applicant to the responsibilities and duties of a

Technical Committee Chairperson as given in the CEN BOSS; decides to re-appoint Michele Bertazzon, as Chairman of CEN/TC 152 for a period of 3 years starting on 2019-01-02, noting that Michele Bertazzon is Chairperson of the Technical Committee since 2006-03-09. The decision was taken by simple majority with 12 positive votes, 0 negative vote(s) and 8 abstentions

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5 CEN/TC 180 DECISION 3/2018 taken by CEN/TC 180 on 2018-09-11 Subject: CEN/TC 180 – Appointment of Chairman CEN/TC 180 « Decentralized gas heating » The CEN/TC 180, - considering the CEN/CENELEC Internal Regulations - Part 2, subclause 3.2.2, which lays down the rules for nomination, appointment and responsibilities of Chairpersons; - noting the nomination by the Technical Committee Secretariat; - noting the commitment of the applicant to the responsibilities and duties of a Technical Committee Chairperson as given in the CEN BOSS; decides to appoint Danny Packham as Chairperson of CEN/TC 180 for a period of three years starting on 2018-12-01. The decision was taken by unanimity.

6 CEN/TC 203 Decision CEN/TC 203 C02/2018 taken on 2018-09-12 Subject: 3 year time-frame for the development of WI 00203055 - 9 month Tolerance Request. CEN/TC 203 Cast iron pipes, fittings and their joints

• considering Resolution BT 34/2002 by which BT decided that any work item to result in an EN, registered after 2002-10-31, shall normally result in an EN after 3 years and set maximum times between well identified stages, as well as Resolution BT 42/2003 deciding on variant timeframes;

• considering Resolution BT 42/2008 allowing the CEN/TCs, for well identified and justified reasons, to claim one tolerance of 9 months, applicable to the target dates for submission of a draft to CCMC (or ISO/CS in case of Vienna Agreement – CEN Lead) for the relevant procedure(s) (i.e. CEN Enquiry and/or Formal Vote, UAP, TCA);

• considering that for work item 00203055 - prEN 598 - Coated and lined ductile iron pipes, fittings and their joints for sewerage and drainage applications - Products characteristics and test and assessment methods, it proves impossible to Dispatch FV draft to CMC by 2018-08-12;

• claims a tolerance of 9 months (i.e. a postponement of 9 months of the deadlines for all the stages not yet reached) for the following reasons: 2nd CEN enquiry

• confirms that CEN/TC 203 will Dispatch FV draft to CMC (or ISO/CS in case of Vienna Agreement - CEN Lead) by 2019-05-12 at the latest.

The decision was taken by simple majority with 14 positive vote(s), 0 negative vote(s) and 6 abstention(s).

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Subject: Adoption of a New Work Item

CEN/TC 216 - Chemical disinfectants and antiseptics

Secretariat: AFNOR Proposal documented in N 1174

1. Deliverable EN


3. Explain the purpose and give a justification for this proposal This Europaen standard is needed for safe hand disinfection against viruses. This European Standard specifies a test for establishing whether a chemical disinfectant for use on hands has a virucidal activity in the fields described in the scope. The laboratory test closely simulates practical conditions of application including pre-drying viruses on hands, contact time, temperature, test organisms and interfering substances, i.e. conditions which may influence the action of chemical disinfectants in practical situations. Each utilization concentration of the chemical disinfectant found by this test corresponds to defined experimental conditions. This document completes the serial of hand phase 2/step 2 tests, e.g. EN 1499, EN 1500, EN 12791

4. Stakeholder categories immediately affected by the proposal Industry and commerce Standards application SMEs Government Academic and research bodies Consumers

5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? All producers and users of chemical disinfections are affected. This standard fulfils especially requirements e. g. Consumer protection and welfare, Innovation, Health/Safe and support also to: public policy and European legislation/ regulation.”

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6. Document developed in drafting body Existing drafting body CEN/TC 216/WG 1 - Human medicine

7. Title Chemical disinfectants and antiseptics — Hygienic handrub virucidal — Test method and requirements (phase 2, step 2) Désinfectants chimiques et antiseptiques — Traitement hygiénique virucide de mains par frictions — Méthode d'essai et prescriptions (phase 2, étape 2) Chemische Desinfektionsmittel und Antiseptika — Viruzide hygienische Händedesinfektion — Prüfverfahren und Anforderungen (Phase 2, Stufe 2)

8. Scope This European Standard specifies a test method simulating practical conditions for establishing whether a product for hygienic handrub reduces the release of virus contamination on hands when rubbed onto the artificially contaminated hands of volunteers. NOTE 1 Attention is drawn to the fact that tests on human volunteers are the subject of legal provisions in certain European countries/regions. This European Standard applies to products for hygienic handrub for use in areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: – in hospitals, in community medical facilities and in dental institutions; – in clinics of schools, of kindergardens and of nursing homes. and may occur in the workplace and in the home. It may also include services such as laundries and kitchens supplying products directly for the patient. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”. NOTE 2 This method corresponds to a phase 2, step 2 test.

9. Proposed Project Leader (including contact details) - optional Dr. Maren Eggers Labor Prof. Gisela Enders & Kollegen, MVZ Rosenbergstr. 85 70193 Stuttgart, Germany Phone: +49 711 6357-130 e-mail: [email protected]

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10. Accessibility aspects Accessibility aspect are not relevant for this NWI. Not relevant for a testing standard

11. Environmental aspects Discharges to soil Emissions to air Use of land Use of water Discharges to water Waste

12. How do you plan to address these environmental aspects? OtherDecision taken during CEN/TC 216 plenary meeting (2010) regarding the forward that have been added to EN 14885:2015.

13. Vienna Agreement No or expected CEN lead

14. The project is based in No document from another organization

15. Link with European Research and/or Innovation project No

16. Track Enquiry + Formal Vote (ENQ+FV)

17. Please provide the target dates for the below key stages Dispatch of 1st Working Draft (20.60): 2019-01-01 Dispatch of Enquiry Draft (30.99): 2019-05-01 Dispatch of Formal Vote Draft (45.99): 2020-06-16


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20. Relation to other legislation or established public policy. Yes BPR 528/2012


22. Commitment The following CEN members (at least five) are committed to participate in the development of the project: SFS SIS BSI DIN NEN

23. The decision was taken by Weighted majority (min. 65%) and unweighted majority (min. 55%) Percentage of positive weighted votes:81.818 Number of positive votes: 9 Number of negative votes: 2 Number of abstentions: 11

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CEN/TC 230 Water analysis


1. Deliverable EN


3. Explain the purpose and give a justification for this proposal In many regions over the world, ground water may show high activity concentrations of radon (Rn-222), especially water from drilled well. Monitoring of Rn-222 in ground water for health protection purpose is herefore important. In Europe and North America, the need for Rn-222 volumic activity concentration etermination is justified by the protection of the public against exposure to Rn-222 in drinking water supplies. Remedial actions are recommended when the radon concentration exceeds 1000 Bq/l in public or commercial distribution in Europe or as low as 10 Bq/l as proposed by the US-EPA. The need of standard on Rn-222 measurement in water samples is thus justified for laboratory carrying out these measurements, required by national authorities, as they have to get a spectific accreditation for Rn-222 measurement in water sample.

4. Stakeholder categories immediately affected by the proposal Industry and commerce SMEs Labour Government Consumers

5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? Knowledge of the quantity of radon in water is an important element in policies relating to the health risks caused by this gas.

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6. Document developed in drafting body Existing drafting body CEN/TC 230 - Water analysis

7. Title Water quality -- Radon-222 -- Part 1: General principles Qualité de l'eau -- Radon 222 -- Partie 1: Principes généraux

8. Scope This part of ISO 13164 gives general guidelines for sampling, packaging, and transporting of all kinds of water samples, for the measurement of the activity concentration of radon-222. The test methods fall into two categories: a) direct measurement of the water sample without any transfer of phase (see ISO 13164-2); b) indirect measurement involving the transfer of the radon-222 from the aqueous phase to another phase (see ISO 13164-3). The test methods can be applied either in the laboratory or on site. The laboratory is responsible for ensuring the suitability of the test method for the water samples tested.

9. Proposed Project Leader (including contact details) - optional Ameon Roselyne Mme

10. Accessibility aspects Accessibility aspect are not relevant for this NWI. No need for accessibility features recognized.

11. Environmental aspects Other This standard specifies a method to investigate environmental parameters.

12. How do you plan to address these environmental aspects? Bring in environmental expertise to the WG


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14. The project is based in An ISO document (not covered by a parallel procedure) Identical ISO project reference: ISO 13164-1 Issue year: 2013 ISO project ID: 53405






20. Relation to other legislation or established public policy. Yes WHO Guidelines for Drinking Water Quality


22. Commitment The following CEN members (at least five) are committed to participate in the development of the project:

23. The decision was taken by Weighted majority (min. 65%) and unweighted majority (min. 55%) Percentage of positive weighted votes:100 Number of positive votes: 13 Number of negative votes: 0 Number of abstentions: 12

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1. Deliverable EN


3. Explain the purpose and give a justification for this proposal Radioactivity from several naturally occurring and human-made sources is present throughout the environment. Thus, water bodies (surface waters, groundwaters, sea waters) can contain radionuclides of natural and origin human-made origin. — Natural radionuclides, including potassium-40, and those of the thorium and uranium decay series, in particular radium-226, radium-228, uranium-234, uranium-238, lead-210, can be found in water for natural reasons (e.g. desorption from the soil and wash-off by rain water) or releases from technological processes involving naturally occurring radioactive materials (e.g. the mining and processing of mineral sands or phosphate fertilizer production and use). — Human-made radionuclides such as transuranium elements (americium, plutonium, neptunium, curium), tritium, carbon-14, strontium-90 and gamma-emitting radionuclides can also be found in natural waters as they can be authorized to be routinely released into the environment in small quantities in the effluent discharged from nuclear fuel cycle facilities and following their used in unsealed form in medicine or industry. They are also found in water due to the past fallout of the explosion in the atmosphere of nuclear devices and the accidents at Chernobyl and Fukushima. Drinking-water can thus contain radionuclides at activity concentration which could present a risk to human health. In order to assess the quality of drinking-water (including mineral waters and spring waters) with respect to its radionuclide content and to provide guidance on reducing health risks by taking measures to decrease radionuclide activity concentrations, water resources (groundwater, river, lake, sea, etc.) and drinking water are monitor for their radioactivity content as recommended by the World Health Organization (WHO). Standard test methods for radon-222 activity concentrations in water samples are needed by test laboratories carrying out such measurements in fulfillment of national authority requirements. Laboratories may have to obtain a specific accreditation for radionuclide measurement in drinking water samples. The radon activity concentration in surface water is very low, usually below 1 Bq l−1. In groundwater, the activity concentration varies from 1 Bq l−1 up to 50 Bq l−1 in sedimentary rock aquifers, from 10 Bq l−1 up to 300 Bq l−1 in wells, and from 100 Bq l−1 up to 1 000 Bq l−1 in crystalline rocks. The highest activity concentrations are normally measured in rocks with high concentration of uranium (Reference [7]). High variations in the activity concentrations of radon in aquifers have been observed. Even in a Region with relatively uniform rock types, some well water may exhibit radon activity

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concentration greatly higher than the average value for the same region. Significant seasonal variations have also been recorded (see Annex A). Water may dissolve chemical substances as it passes from the soil surface to an aquifer or spring waters. The water may pass through or remain for some time in rock, some formations of which may contain a high concentration of natural radionuclides. Under favourable geochemical conditions, the water may selectively dissolve some of these natural radionuclides. Guidance on radon in drinking-water supplies provided by WHO in 2008 suggests that controls should be implemented if the radon concentration of drinking-water for public water supplies exceeds 100 Bq l−1. It also recommended that any new, especially public, drinking-water supply using groundwater should be tested prior to being used for general consumption and that if the radon concentration exceeds 100 Bq l−1, treatment of the water source should be undertaken to reduce the radon levels to well below that level (Reference [8]). This International Standard is one of a series dealing with the measurement of the activity concentration of radionuclides in water samples. The origin of radon-222 and its short-lived decay products in water and other measurement methods are described generally in ISO 13164-1.

4. Stakeholder categories immediately affected by the proposal Industry and commerce SMEs Government Consumers

5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? This test method can be used successfully with drinking water samples.


7. Title Water quality -- Radon-222 -- Part 2: Test method using gamma-ray spectrometry Qualité de l'eau -- Radon 222 -- Partie 2: Méthode d'essai par spectrométrie gamma

8. Scope This part of ISO 13164 specifies a test method for the determination of radon-222 activity concentration in a sample of water following the measurement of its short-lived decay products by direct ammaspectrometry of the water sample (see Annex A). The radon-222 activity concentrations, which can be measured by this test method utilizing currently available gamma-ray instruments, range from a few becquerels per litre to several hundred thousand becquerels per litre for a 1 l test sample. This test method can be used successfully with drinking water samples. The laboratory is responsible for ensuring the validity of this test method for water samples of untested matrices. Annex B gives indication on the necessary counting conditions to meet the required sensitivity for drinking water monitoring.

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1. Deliverable EN


3. Explain the purpose and give a justification for this proposal Standard test methods for radon-222 activity concentrations in water samples are needed by test laboratories carrying out measurements in fulfillment of national authority requirements.


5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? This test method is used successfully with drinking water samples.


7. Title Water quality — Radon-222 — Part 3: Test method using emanometry Qualité de l’eau — Radon 222 — Partie 3: Méthode d’essai par émanométrie

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8. Scope This part of ISO 13164 specifies a test method for the determination of radon-222 activity concentration in a sample of water following its transfer from the aqueous phase to the air phase by degassing and ist detection. It gives recommendations for rapid measurements performed within less than 1 h. The radon-222 activity concentrations, which can be measured by this test method utilizing currently available instruments, range from less than 0,1 Bq l−1 to several hundred thousand becquerels per litre for a 100 ml test sample. This test method is used successfully with drinking water samples. The laboratory is responsible for ensuring the validity of this test method for water samples of untested matrices. This test method can be applied on field sites or in the laboratory. Annexes A and B give indications on the necessary counting conditions to meet the required sensitivity for drinking water monitoring.








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1. Deliverable EN


3. Explain the purpose and give a justification for this proposal Standard test methods for radon-222 activity concentrations in water samples are needed by test laboratories carrying out measurements in fulfillment of national authority requirements.


5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? This test method can be used successfully with drinking water samples.


7. Title Water quality — Radon-222 — Part 4: Test method using two-phase liquid scintillation counting Qualité de l’eau — Radon 222 — Partie 4: Méthode d’essai par comptage des scintillations en Milieu liquide à deux phases

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8. Scope This part of ISO 13164 describes a test method for the determination of radon 222 (222Rn) activity concentration in non-saline waters by extraction and liquid scintillation counting. The radon-222 activity concentrations, which can be measured by this test method utilizing currently available instruments, are at least above 0,5 Bq l−1 for a 10 ml test sample and a measuring time of 1 h. This test method is used successfully with sample of drinking water and it is the laboratory responsibility to ensure the validity of this test method for water samples of untested matrices. Annexe A gives indication on the necessary counting conditions to meet the required detection limits for drinking water monitoring.

9. Proposed Project Leader (including contact details) - optional Forte Maurizio Mr







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9 CEN/TC 286 Decision CEN/TC 286 C10/2018 taken on 2018-08-17


CEN/TC 286 Liquefied petroleum gas equipment and accessories

Secretariat: NSAI Proposal documented in N 1936

1. Deliverable EN

2. This item corresponds to The revision of an EN EN 12493:2013+A2:2018

3. Explain the purpose and give a justification for this proposal Decision CEN/TC 286 C10/2018: Considering a presentation given by WG 1 at the CEN/TC 286 Plenary in May, highlighting the conflict with EN 12972 and ISO 5817 regarding welding, WG 1 of CEN/TC 286 requests CEN/TC 286 to launch a NWIP for the revision of EN 12493:2013.

4. Stakeholder categories immediately affected by the proposal Industry and commerce Standards application

5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? alignment with the requirements of EN ISO 5817

6. Document developed in drafting body Existing drafting body CEN/TC 286/WG 1 - Design and manufacture of LPG pressure vessels

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7. Title LPG equipment and accessories - Welded steel pressure vessels for LPG road tankers - Design and manufacture Équipements pour GPL et leurs accessoires - Réservoirs sous pression en acier soudés des camions-citernes pour GPL - Conception et construction Flüssiggas-Geräte und Ausrüstungsteile - Geschweißte Druckbehälter aus Stahl für Straßentankwagen für Flüssiggas (LPG) - Auslegung und Herstellung

8. Scope This European Standard specifies minimum requirements for materials, design, construction and workmanship procedures, and tests for welded LPG road tanker pressure vessels and their welded attachments manufactured from carbon, carbon/manganese and micro alloy steels. There is no upper size limit as this is determined by the gross vehicle weight limitation. This European Standard does not cover pressure vessels for pressure vessel containers. NOTE 1 In the context of this standard the term "road tanker" is understood to mean "fixed tanks" and "demountable tanks" as defined in ADR. NOTE 2 The equipment for the pressure vessels and the inspection and testing after assembly is covered by EN 12252 and EN 14334, respectively. NOTE 3 The design type of the road tanker is subject to approval by the competent authority, as required by ADR. NOTE 4 This standard is intended for LPG only; however for other liquefied gases see EN 14025

9. Proposed Project Leader (including contact details) - optional Tony Neale

10. Accessibility aspects Accessibility aspect are not relevant for this NWI. Not applicable

11. Environmental aspects Emissions to air Noise/Vibration Use of energy Use of land Use of materials Use of water Waste Risk to the environment from accidents/misuse

12. How do you plan to address these environmental aspects? OtherRefer to CEN/TS 16765:2015 "LPG equipment and accessories - Environmental considerations for CEN/TC 286 standards"

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18. Related standardization request(s) (formely mandate) Yes M/086

19. Related directive(s)/regulation(s) Yes Directive reference | For citation in Official journal 2008/68/EC | No

20. Relation to other legislation or established public policy. No


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22. Commitment The following CEN members (at least five) are committed to participate in the development of the project: AFNOR SFS BSI DIN UNI NSAI


10 CEN/TC 305 Decision CEN/TC 305 C357/2018 taken on 2018-09-03

Subject: Activation of a Preliminary Work Item

CEN/TC 305 - Potentially explosive atmospheres - Explosion prevention and protection


1. Deliverable EN


3. Explain the purpose and give a justification for this proposal Re-Adoption of the PWI due to deletion because of the 3-years-timetable for PWIs

4. Stakeholder categories immediately affected by the proposal Industry and commerce Labour

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5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? This European Standard deals with all significant hazards, hazardous situations and events relevant to vacuum cleaners and dust collectors, when they are used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer.

6. Document developed in drafting body Existing drafting body CEN/TC 305/WG 2 - Equipment for use in potentially explosive atmospheres (provisional title)

7. Title Requirements for design and testing of vacuum cleaners and dust collectors for use in potentially explosive atmospheres

8. Scope This European Standard specifies requirements for design, construction, testing and marking of handheld, portable and transportable vacuum cleaners and dust collectors, including their accessories, constructed to Group II categories 2G and 3G and to Group II categories 2D and 3D, intended for the collection of combustible or non-combustible dusts and flammable or non260 flammable liquids in potentially explosive atmospheres. A potentially explosive atmosphere may be generated by the equipment during its intended use. It covers equipment driven by electricity and by pneumatic power. This European Standard deals with all significant hazards, hazardous situations and events relevant to vacuum cleaners and dust collectors, when they are used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer. Typical applications for the concerned equipment are: - Collection of dust produced by machinery at the point of generation - General housekeeping around machinery and of working areas - And/or collection of spills. For other specific applications a specific assessment shall be performed. This European Standard does not cover equipment used to collect toxic dusts where there is a health risk if dust passes through the filter element. This European Standard does not cover either the collection of dusts which have explosive and unstable properties (UN transport class 1, class 4.1 and class 5.2). This European Standard covers vacuum cleaners with an internal dust loaded volume of maximum 200 liters

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This European Standard does not apply to pumps, where the inlet nozzle is submerged into a liquid, and all conveying applications. This European Standard does not apply to Group I vacuum cleaners and dust collectors for mining. For an easier readability, all types of equipment concerned by this standard are referred as “Vacuum cleaner” in this document. NOTE Where undated references are used in the body of the standard the latest edition applies

9. Proposed Project Leader (including contact details) - optional

10. Accessibility aspects Accessibility aspect are not relevant for this NWI. This is a safety Standard dealing with the protection and prevention of explosions in vaccuum cleaners for industrial use

11. Environmental aspects Discharges to water Risk to the environment from accidents/misuse






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18. Related standardization request(s) (formely mandate) Yes M/BC/CEN/92/46

19. Related directive(s)/regulation(s) Yes Directive reference | For citation in Official journal 2014/34/EU | Yes



22. Commitment The following CEN members (at least five) are committed to participate in the development of the project: AFNOR BSI DIN DS UNI UNMZ


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CEN/TC 339 - Slip resistance of pedestrian surfaces - Methods of evaluation

Secretariat: Proposal documented in N 266

1. Deliverable EN

2. This item corresponds to The conversion of a CEN/TS into an EN CEN/TS 16165:2016

3. Explain the purpose and give a justification for this proposal This document describes the most commonly used test methods in Europe for the determination of the slip resistance of floorings in the most commonly encountered situations in which pedestrians walk.

4. Stakeholder categories immediately affected by the proposal Industry and commerce SMEs Labour Government Academic and research bodies Consumers

5. How will these Stakeholders benefit from or be impacted by the proposed deliverable? Slips cause a lot of injuries and cost the European Industry and Society Billions of Euros per year. This document will help the stakeholders to measure the slip resistaance of a flooring and will thus help to prevent slips.

6. Document developed in drafting body Existing drafting body CEN/TC 339 - Slip resistance of pedestrian surfaces - Methods of evaluation

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7. Title Determination of slip resistance of pedestrian surfaces - Methods of evaluation Détermination de la résistance à la glissance des surfaces piétonnières - Méthodes d'évaluation Bestimmung des Gleitwiderstandes von Fußgängerbereichen - Ermittlungsverfahren

8. Scope This Technical Specification specifies test methods for the determination of the slip resistance of surfaces in the most commonly encountered situations in which pedestrians walk. This Technical Specification does not cover sports surfaces and road surfaces for vehicles (skid resistance).

9. Proposed Project Leader (including contact details) - optional

10. Accessibility aspects

11. Environmental aspects None of the above

12. How do you plan to address these environmental aspects?




16. Related standardization request(s) (formely mandate) Yes M/127

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17. Related directive(s)/regulation(s) Yes Directive reference | For citation in Official journal 305/2011 | No




12 CEN/TC 441 DECISION 2018-01 taken by CEN/TC 441 on 2018-08-22 Subject: CEN/TC 411 - Appointment of Chairperson The CEN/TC 441, Project Committee Fuel labeling, - considering the CEN/CENELEC Internal Regulations - Part 2, subclause 3.2.2, which lays down the rules for nomination, appointment and responsibilities of Chairpersons; - noting the nomination by the Technical Committee Secretariat as presented in document N054; - noting the willingness of the candidate to adopt the role and the support given by NEN; - noting the commitment of the applicant to the responsibilities and duties of a Technical Committee Chairperson as given in the CEN BOSS; decides to appoint Benoit Engelen, Total Belgium, as Chairperson of CEN/TC 441 for a period of 3 years starting on 2018-09-11. The decision was taken by unanimity.

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13 CEN/TC 458 Decision 2018/01 taken by CEN/TC 458 on 2018-09-05 Subject: CEN/TC 458 Appointment of Chairperson CEN/TC 458 "Stirring and mixing industrial equipment", meeting on 2018-09-05 in Paris La Défense, - considering the CEN/CENELEC Internal Regulations - Part 2, subclause 3.2.2, which lays down the rules for nomination, appointment and responsibilities of Chairpersons; - noting the nomination by the Technical Committee Secretariat; - noting the commitment of the applicant to the responsibilities and duties of a Technical Committee Chairperson as given in the CEN BOSS; decides to appoint Mr Patrice COGNART as Chairperson of CEN/TC 458 for a period of 6 years starting on 2018-09-05. The decision was taken by unanimity.

14 CEN/TC 350 DECISION 236 taken by CEN/TC 350 on 2018-09-06 Subject: CEN/TC 350 - Appointment of Chairperson

The CEN/TC 350 Sustainability of construction works, - considering the CEN/CENELEC Internal Regulations - Part 2, subclause 3.2.2, which lays down the rules for nomination, appointment and responsibilities of Chairpersons; - noting the nomination by the Technical Committee Secretariat; - noting the commitment of the applicant to the responsibilities and duties of a Technical Committee Chairperson as given in the CEN BOSS; (Option 1 ) decides to appoint name of person as Chairperson of CEN/TC number for a period of number of years years starting on CCYY-MM-DD. (Option 2 ) decides to re-appoint Ari ILOMAKI, as Chairman of CEN/TC 350 for a period of 3 years starting on 2018-10-23 , noting that Ari ILOMAKI is Chairperson of the Technical Committee since 2005-10-05. The decision was taken by unanimity or simple majority with 16 positive votes, 0 negative vote(s) and 5 abstention(s).

Documents

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