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Sotsiaalministeerium · 2. juuni 2023
Viit
5.1-2/2314-1
Registreeritud
2. juuni 2023
Dokumendi liik
Sissetulev kiri
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Eesti Standardimis- ja Akrediteerimiskeskus
Saabumis/saatmisviis
e-post
Funktsioon
5.1 Tervisekaitse, haiguste ennetamise ja tervise edendamise korraldamine
Sari
5.1-2 Tervisekaitse ja tervisliku elukeskkonna kavandamise ja korraldamisega seotud kirjavahetus (Arhiiviväärtuslik)
Toimik
5.1-2/2023
Vastutaja
Mall Hiet2
Lahendamise tähtaeg
7. juuli 2023

Failid

  • 📎2023_c065_BT_N_14200.pdf345 KB
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CEN Reference: BT N 14200 Draft BT C065/2023 CENELEC Reference: BT175/DG13744/DV Simultaneous circulation to CEN and CENELEC TECHNICAL BOARDS BT by correspondence CENELEC Agenda item: 5.1.2 For vote in line with IR2 Clause 6.1.4 Issue date: 2023-05-03 Deadline: 2023-07-25 SUBJECT CEN-CLC/JTC on Horizontal topics for PPE - Creation BACKGROUND On 19 April 2023, BSI submitted a proposal to CCMC for the creation of a new CEN-CENELEC Joint Technical Committee (CEN-CLC/JTC) on 'Horizontal topics for Personal Protective Equipment (PPE)'. A detailed explanation is provided in the ‘proposal for a new field of activity’ form (see Annex). Purpose and justification for the proposal Placing work items that cover more than one product in a horizontal CEN-CLC/JTC would ensure that the subjects are treated in a neutral way and not given a potential imbalance by placing them under the lead of one of the product TCs. Stakeholders in the horizontal neutral JTC are experts from different product TCs as well as experts familiar with different sectors/ hazards. Quite often the latter are users of Personal Protective Equipment (PPE), which are lost in PPE product TCs as these focus on one part of the ensemble only and not the complete set. The horizontal JTC will not produce specific product standards but deliverables encompassing horizontal matters (so valid for different types of PPE not only one type). The horizontal JTC’s deliverables will be implemented within the specific product TCs according to their scope. This horizontal JTC would also mirror the horizontal topics dealt with under ISO/TC 94 directly which are not being dealt with in the product TCs of CEN. Proposed scope: Standardization of deliverables that are encompassing more than one type of PPE product. As the purpose of the Horizontal Joint Technical Committee (JTC) will not be product specific, its intention is to standardize in the following Horizontal topics (although the below is a non- exhaustive list): 1 1. Maintenance and/or adoption of standards and/or other CEN/CENELEC – ISO/IEC deliverables which in the past were developed by CEN-CLC JWGs or by ISO bodies not mirrored in CEN 2. Dual function PPE 3. Integration of smart textiles/ electronics or (other) wearables. 4. Ensembles/ Personal protective systems (PPS) 5. Focus on specific sectors or hazards 6. Sustainability in PPE 7. Ergonomics & comfort of PPE systems The JTC will submit its final title and scope for CEN and CENELEC BTs approval, after its kick- off meeting. By BT 006/2020 and D164/004, CEN and CENELEC BTs respectively decided that the following criteria are to be met for creation a CEN-CLC/JTC: - 12-week consultation by correspondence; - Vote according to IR2 clause 6.1.4 in CEN and CENELEC; - At least 5 countries committed to participate. Consequently, Members are requested to state explicitly whether or not they are committed to participate in the work: - CEN by means of the commenting field provided in the BT balloting tool; - CENELEC on the Collaboration Platform under the relevant item. PROPOSAL(S) BT, ­ having considered the BSI proposal for a new field of technical activity on 'Horizontal topics for Personal Protective Equipment (PPE)' in Annex; ­ having considered that the following Members have expressed commitment to participate: <Members>; ­ decided to create a new CEN-CLC/JTC XXX ‘'Horizontal topics for Personal Protective Equipment (PPE)’ with the following preliminary scope: Standardization of deliverables that are encompassing more than one type of PPE product. As the purpose of the Horizontal JTC will not be product specific, its intention is to standardize in the following Horizontal topics (although the below is a non-exhaustive list): 1. Maintenance and/or adoption of standards and/or other CEN/CENELEC - ISO/IEC deliverables which in the past were developed by CEN-CLC JWGs or by ISO bodies not mirrored in CEN 2. Dual function PPE 3. Integration of smart textiles/ electronics or (other) wearables 4. Ensembles/ Personal protective systems (PPS) 2 5. Focus on specific sectors or hazards 6. Sustainability in PPE 7. Ergonomics & comfort of PPE systems  allocated the secretariat of CEN-CLC/JTC XXX to BSI;  asked the new CEN-CLC/JTC XXX to submit its final title and scope for BT approval, following its first kick-off meeting. 2023-04-20 – JO 3 PROPOSAL for a NEW FIELD OF TECHNICAL ACTIVITY Date of circulation CEN/TC / SC N …………. ……………………. (where appropriate) Secretariat CENELEC/TC / SC (Sec) ………. BSI (where appropriate) Type of technical body CEN-CLC JTC proposed (TC / SC / BTTF) ……………………………………….. IMPORTANT NOTE: Incomplete proposals risk rejection or referral to originator. The proposer has considered the guidance given in Annexes 1 and 2 during the preparation Proposal (to be completed by the proposer) Title of the proposed new subject (The title shall indicate clearly and unambiguously, yet concisely, the new field of technical activity which the proposal is intended to cover.) Horizontal topics for Personal Protective Equipment (PPE) Scope statement of the proposed new subject (The scope shall precisely define the limits of the new field of technical activity. Scopes shall not repeat general aims and principles governing the work of the organization but shall indicate the specific area concerned.) Standardization of deliverables that are encompassing more than one type of PPE product. As the purpose of the Horizontal JTC will not be product specific, its intention is to standardize in the following Horizontal topics (although the below is a non-exhaustive list): 1. Maintenance and/or adoption of standards and/or other CEN/CENELEC – ISO/IEC deliverables which in the past were developed by CEN-CLC JWGs or by ISO bodies not mirrored in CEN 2. Dual function PPE 3. Integration of smart textiles/ electronics or (other) wearables. 4. Ensembles/ Personal protective systems (PPS) 5. Focus on specific sectors or hazards 6. Sustainability in PPE 7. Ergonomics & comfort of PPE systems Purpose and justification for the proposal. Placing work items that cover more than one product in a horizontal CEN-CLC JTC would ensure that the subjects are treated in a neutral way and not given a potential imbalance by placing them under the lead of one of the product TCs. Stakeholders in the horizontal neutral JTC are experts from different product TCs as well as experts familiar with different sectors/ hazards. Quite often the latter are users of Personal Protective Equipment (PPE), which are lost in PPE product TCs as these focus on one part of the ensemble only and not the complete set. The horizontal JTC will not produce specific product standards but deliverables encompassing horizontal matters (so valid for different types of PPE not only one type). The horizontal JTC’s deliverables will be implemented within the specific product TCs according to their scope. This horizontal JTC would also mirror the horizontal topics dealt with under ISO/TC 94 directly which are not being dealt with in the product TCs of CEN. Areas of work for the horizontal TC would include (non-exhaustive list): 1 1) Maintenance and/or adoption of standards and/or other CEN/CENELEC – ISO/IEC deliverables which in the past were developed by CEN-CLC JWGs or by ISO bodies not mirrored in CEN, for example: o CEN/CLC/TR 16832:2015 “Selection, use, care and maintenance of personal protective equipment for preventing electrostatic risks in hazardous areas” (explosion risks) (CEN/CLC/JWG 7, disbanded) o ISO 23616:2022 “Cleaning, inspection and repair of firefighters' personal protective equipment (PPE)” (ISO/TC 94/SC 14)* o ISO/TR 21808:2021 “Guidance on the selection, use, care and maintenance of personal protective equipment (PPE) designed to provide protection for firefighters” (ISO/TC 94/SC 14)* o ISO/TS 20141:2022 “Guideline on compatibility of PPE” (ISO/TC 94/WG 1)* Currently standards and other documents are focusing on the individual parts of the PPE but the user may not understand that the conditions for testing may be different for the different parts. Therefore, an assessment needs to be completed to ensure protection at the same level is achieved by the different PPE worn by the user during an activity. This is different from physiological compatibility. * Documents which are of interest to introduce in CEN but which are outside the scope of any of the individual PPE CEN/CENELEC TCs. These documents are of particular interest to users and would need input from different PPE CEN/CENELEC TCs. For this reason, they would be best placed in the horizontal JTC. Such documents can also not be taken up into standardization request M/571 for the moment as there is no TC which could take the project into their work program. 2) Dual function PPE o Develop general guidelines and horizontal documents for dual use (PPE and e.g. ATEX), to be implemented for the different types of combinations. This should include methodology to combine the requirements under the EU legislations applicable to both types of devices. The most strenuous certification process should be adhered to, while today one or the other regulation may be (and is) followed, at the choice of the manufacturer (based on the claims rather than the risks and on the perception of the market). For example: protection from electrostatic risks, combination PPE-ATEX regulation (see also CEN/CLC/TR 16832:2015) 3) Integration of smart textiles/ electronics or (other) wearables. CEN/TC 162 agreed to take the lead on smart garments, but there are also other TCs working on integrated electronics (e.g. hearing protection). o Establishing general principles would ensure that the approach in all PPE product TCs would be the same; specific work can then be developed in the product TCs. o Smart body area networks, with nodes located on different parts of the PPE ensemble are under development – developing standards for testing and verifying the functioning of these ensemble wide structures is best allocated to this horizontal JTC. o Smart Personal protective systems (smart PPS), covering not only the PPE (ensemble) but also external monitoring, data processing & data storage systems. o Linking smart PPS to Artificial Intelligence (AI) and Internet of Things (IoT). 4) Ensembles/Personal protective systems (PPS): include all types of PPE, it is therefore difficult to cover individually in the product TCs. See points 1, 2 and 6 for more details. 5) Focus on specific sectors or hazards: o The horizontal JTC will develop general principles, per hazard, which will ensure that the approach in all PPE product TCs is the same; specific work can then be developed in the product TCs as needed. o Examples for sectors/hazards could be: 2 ▪ Firefighters: the JWG has been placed under the PPE SF to keep it active for monitoring the work of ISO/TC 94/SC 14, but under the PPE SF they are not able to work on standards development (see also point 1) ▪ CBRN(E) (chemical, biological, radiological, nuclear, (explosive)); ISO/TC 94 has a JWG between ISO/TC 94/SC 13 and SC 14, being ISO/TC 94/SC 14/JWG 1, which is developing ISO/CD 24588 “Protective clothing - Personal protective ensembles for use against chemical, biological, radiological and nuclear (CBRN) agents - Classification, performance requirements and test methods” Note: In most cases direct attack is considered, but in principle the scope could be broader. It is important to consider the full ensemble. ▪ Electrostatic/explosion risks (see also CEN/CLC/TR 16832:2015) ▪ Electrical hazards, e.g. related to servicing electrical cars or other vehicles, as well as electrical power generators like windmills and (domestic) solar panels. Domestic batteries for energy storage are also expected to become more important in the future. A variety of different workers are affected by these hazards, including rescue and breakdown services. 6) Sustainability: The PPE SF task group sustainability is in the process of analyzing the needs for the PPE sector to meet the goals of the EU Green deal (https://ec.europa.eu/info/strategy/priorities- 2019-2024/european-green-deal_en). As this topic is new to the PPE sector and since all PPE products will need to balance the requirements of Regulation (EU) 2016/425 against the goals of the EU green deal, the task group recommends developing horizontal recommendations and requirements for circular economy and sustainability, which then could be further developed into product specific documents, if needed. The following topics have been identified as important by the PPE SF TG Sustainability (non- exhaustive):  Design for circular economy & sustainability  Modular design  Longevity / durability  Maintenance  Repair  Recycling  Re-use  Disposal A first need identified by the PPE SF TG Sustainability is a document on how to apply the general principles of sustainability and circular economy to personal protective equipment. 7) Ergonomics & comfort of PPE systems CEN/TC 122/WG 14 “Ergonomics of PPE systems” is positioned under CEN/TC 122 but is focusing on PPE systems only. This WG developed EN 17558:2022 “Ergonomics - Ergonomics of PPE ensembles”. There is a strong link between this document and ISO/TS 20141:2022, but some discrepancies have already been identified, including a need to clarify the definition of PPE system/ ensemble. The proposed JTC and CEN/TC 122 could consider if both documents could be brought into the new horizontal JTC for better alignment. Also, for the moment CEN/TC 122/WG 14 has to link with all PPE TCs. A more efficient way of linking this WG to PPE would be to establish either a closer cooperation with the proposed horizontal JTC (e.g. a mode 4 cooperation) or for this proposed JTC and CEN/TC 122 to consider moving this working group to this proposed horizontal PPE JTC. Many experts in CEN/TC 122/WG14 are experts in one or more PPE TCs; moving the WG to the horizontal PPE JTC would facilitate their participation, as most are not interested in general ergonomics. 3 Working on topics covering more than one PPE product used to be possible in the past by establishing joint WGs (JWGs). Given the administrative difficulties with such bodies CEN started to discourage and finally disbanded all existing JWGs and does not allow for establishing new ones. The only option for working on horizontal topics is currently by establishing so-called horizontal TCs, e.g. CEN/TC 350 “Sustainability of construction works” and CEN/TC 351 “Construction Products - Assessment of release of dangerous substances”, or CEN/CLC/JTC 3 “Quality management and corresponding general aspects for medical devices” and CEN/CLC/JTC 16 “Active Implantable Medical Devices”. After publication of the final CEN/CLC BTWG 8 report, a proposal for a horizontal PPE TC was prepared but not accepted by the CEN and CENELEC BTs. Some BT members felt that the proposal was not substantiated enough. After analyzing the BTWG 8 report once more as well as looking into the new developments since this report was written, the CEN-CLC PPE Sector Forum concludes that there are now a substantial amount of well-defined topics which would better be addressed in a neutral horizontal way for all PPE products or which are currently not covered at all by any of the existing PPE product TCs in CEN or CENELEC, giving more substance and a more clear definition of the tasks for a horizontal PPE JTC. Especially the emerging hazards associated with electric hazards (see ‘Scope’, item 6) require involvement of both CEN and CENELEC experts. Hence the need for establishing a CEN-CLC Joint horizontal TC. It is not the intention to increase the workload of experts, but on the contrary increase the efficiency of the work on topics that are horizontal. While the PPE sector forum is working on horizontal topics, the SF has no possibility to prepare CEN or CENELEC deliverables, nor can the SF mirror e.g. the horizontal work of ISO/TC 94 Is the proposed new subject actively, or probably, in support of European legislation or established public policy? Yes No If Yes, indicate if the proposal is ▪ in relation to EC mandate(s): M/571 as regards personal protective equipment in support of Regulation (EU) 2016/425 ▪ in relation to EC Directive(s)/Regulation(s): Regulation (EU) 2016/425 on Personal Protective Equipment Directive 89/ 656 EEC on the introduction of measures to encourage improvements in the safety and health of workers at work Regulation EU 2017/ 745 on Medical Devices Regulation EC 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment Text with EEA relevance (formerly RoHS) Directive 2014/34/EU on the harmonisation of the laws of the Member States relating to equipment and protective systems intended for use in potentially explosive atmospheres (ATEX) Directive 2014/30/EU on the harmonisation of the laws of the Member States relating to electromagnetic compatibility (EMC) Additional EU legislation may also apply depending on the specific application or construction of the PPE. ▪ in relation to other legislation or established public policy: “EU Green Deal” (Including the “circular economy action plan” which includes the “EU strategy for sustainable textiles” and the EU “Plastics strategy”, “A Europe fit for the digital age”. Proposed initial programme of work The proposed structure for this JTC and the assignment of new projects is to highlight specific issues, however, the horizontal JTC will discuss and finalise the structure, once approved: WG1 General 1) Compatibility a) NWI proposal: Adoption of ISO/TS 20141:2022 Guideline on compatibility of PPE 4 b) Ergonomics design and evaluation of integrated PPE systems (CEN TC122 WG14); Discuss with CEN/TC 122 the possibility of transferring the WG and its work programme to the new JTC.  EN 13921:2007 “Personal protective equipment - Ergonomic principles”  EN 17558:2022 “Ergonomics - Ergonomics of PPE ensembles” The work on ergonomics currently does not sufficiently take into account diversity, e.g. age, gender and size. Future versions of compatibility and ergonomic standards need to incorporate this. 2) Firefighters: Evaluate adoption of the standards and currently active WI from ISO/TC 94/SC 14, (please refer to the list in Annex II). 3) CBRN ensembles, including the work in ISO/TC 94/SC 14/JWG 1, which is developing ISO/CD 24588 “Protective clothing - Personal protective ensembles for use against chemical, biological, radiological and nuclear (CBRN) agents - Classification, performance requirements and test methods”: NWI proposal to adopt ISO/CD 24588. 4) Innovative products. WG2 Sustainability and circular economy NWI proposal guidance for manufacturers of PPE (design for circularity and sustainability) NWI proposal guidance for users of PPE (sustainable maintenance and disposal) More proposals are expected to follow from TG sustainability under the PPE SF WG3 Integrated smart elements and electronics NWI proposals: Generalise the documents prepared under M/553 for all PPE and all hazards: - CEN/TR 17512:2020 “Personal protective equipment - Smart garments - Terms and definitions” - CEN/TR 17620:2021 “Guidelines for selection, use, care and maintenance of smart garments protecting against heat and flame” - EN 17673:2022 “Protective clothing - Protection against heat and flame - Requirements and test methods for garments with integrated smart textiles and non textile elements” NWI proposal: text method for testing of electronics integrated into PPE under extreme conditions (high and low temperature, humidity, etc.). A workshop was held on June 2, 2022 (https://www.cencenelec.eu/news-and-events/events/2022/2022-06-02-sector-forum-ppe/). WG 4 Dual function PPE Develop general principles for dual use PPE. 1) ATEX Electrostatic/ explosion risks: NWI proposal: revision of CEN/CLC/TR 16832:2015 Selection, use, care and maintenance of personal protective equipment for preventing electrostatic risks in hazardous areas (explosion risks). 2) Medical devices Some specific examples are currently under development:  ISO/TC 94/SC 13/WG 6 “Protective clothing against hazardous biological agents” is developing documents which are optional dual use: ▪ prEN ISO 22615 “Protective clothing — Performance requirements and test methods for protective clothing against infective agents” 5 ▪ ISO/WD 20384 “Medical gowns, surgical drapes and protective apparel — Performance requirements, performance levels and test methods”  CEN/TC 205/WG 17 “Infection protection masks” is developing a document for dual use masks: ▪ WI 00205368 “Respiratory infection prevention devices for self- and third party protection - Requirements for different performance classes and test methods” The CEN-CLC SF Personal Protective Equipment and CEN SF Health Care also organized a workshop on October 5, 2022 on the topic of dual use PPE – MD, https://www.cencenelec.eu/news-and-events/events/2022/2022-10-05-workshop-md-dual- use-products/. The outcome of this workshop will help identify further topics for NWI proposals. Cooperation with the respective CEN and CENELEC TCs dealing with the other applicable legislation will be established. WG 4 would cooperate in developing the dual use documents. A statement from the proposer as to how the proposed work may relate to or impact on existing work, especially existing CEN, CENELEC, ISO and IEC deliverables. The whole purpose of having product TCs was to focus on the different type of PPE. As a result, there is a gap when it comes to general items applying to all products as well as issues dealing with compatibility and ergonomics of the different products as well as ensembles of PPE. Placing work items that cover more than one product or which address compatibility of more than one product in a horizontal CEN/CLC JTC would ensure that the subjects are treated in a neutral and horizontal way and not given a potential imbalance by placing them under the lead of one of the product TCs. Stakeholders in the horizontal JTC would be experts from different product TCs as well as experts familiar with different sectors/ hazards. Quite often the latter are PPE users, which are lost in PPE product TCs as these focus on one part of the ensemble only and not the complete set. This horizontal JTC would also mirror the horizontal work of ISO/TC 94 and provide a working group to mirror ISO/TC 94/SC 14, neither of which is possible with the current set of PPE TCs. A listing of relevant existing documents at the international, regional and national levels. Any known relevant documents (such as standards and regulations) shall be listed, regardless of their source, and should be accompanied by an indication of their significance. Please refer to Annex I and II. Known patented items Yes No If "Yes", see CEN-CENELEC Guide 8 and provide full information in an annex A simple and concise statement identifying and describing relevant affected stakeholder categories (including small and medium sized enterprises) in particular those who are immediately affected from the proposal (see Annexes 1 and 2) and how they will each benefit from or be impacted by the proposed deliverable(s)  Manufacturers of PPE  Notified bodies  Testing laboratories  Research and academia  Government/ Market surveillance  Users of PPE, including consumers  Trade unions (ETUC, TUTB)  Occupational health and safety supervisors  Trade associations 6 Liaisons: Joint/parallel work: A listing of relevant external European or international Possible joint/parallel work with: organizations or internal parties (other CEN, CENELEC, CEN (please specify committee ID) ETSI, ISO and/or IEC committees) to which a liaison should potentially any TC in liaison be established (in the case of ISO and IEC committees via the Vienna or Dresden Agreements). CENELEC (please specify committee ID) potentially any TC in liaison The proposed horizontal JTC would be working closely together with the existing PPE product ISO (please specify committee ID) ISO TC94 TCs as well as the PPE Sector Forum. The PPE IEC (please specify committee ID) Sector Forum, to which all PPE TCs participate, Other (please specify) can assist with identifying horizontal topics. List of CEN/CENELEC PPE and related TCs and Sector Fora: CEN TC79 - Respiratory protective devices CEN TC85 - Eye protective equipment CEN TC122 - Ergonomics CEN TC137 - Assessment of workplace exposure to chemical and biological agents CEN TC158 - Head protection CEN TC159 - Hearing protectors CEN TC160 - Protection against falls from height including working belts CEN TC161 - Foot and leg protectors CEN TC162 - Protective clothing including hand and arm protection and lifejackets CEN TC231 - Mechanical vibration and shock CEN TC248 – Textiles and textile products CLC SR124 (IEC TC124) - Wearable Electronic Devices and Technologies CLC TC78 (IEC TC78) - Equipment and tools for live working CLC TC101 (IEC TC101) - Electrostatics CEN-CLC JTC 21 Artificial Intelligence CEN-CLC Sector Forum for Personal Protective Equipment CEN Sector Forum for Occupational Health and Safety CEN-CLC Sector Forum for Security CEN-CLC SABE CE-TG Related ISO TCs: ISO/TC 94 Personal safety -- Personal protective equipment, including all subcommittees 7 Name of the Proposer (include contact details) Proposed by the PPE Sector Forum, with BSI committed to hold the secretariat of the new committee. Contact person: Sara Gibbs Email: [email protected] An expression of commitment from the proposer to provide the committee secretariat if the proposal succeeds. BSI is committed to providing the committee secretariat and supporting the work of this proposed JTC. Signature of the proposer PPE Sector Forum (In collaboration with BSI as proposed holder of the Secretariat Alice Kasasian Brown UK CEN/BT member and CENELEC/BT Permanent Delegate) Annex(es) are included with this proposal (give details) Annex I: List of relevant documents Annex II: List of documents under development in ISO TC94 SC14 8 Annex I: List of relevant documents CEN/ ISO publications and documents under development WI 00205368 “Respiratory infection prevention devices for self- and third party protection - Requirements for different performance classes and test methods” prEN ISO 22615 “Protective clothing — Performance requirements and test methods for protective clothing against infective agents” EN 17673:2022 “Protective clothing - Protection against heat and flame - Requirements and test methods for garments with integrated smart textiles and non textile elements” EN 17558:2022 “Ergonomics - Ergonomics of PPE ensembles” CEN/TR 17512:2020 “Personal protective equipment - Smart garments - Terms and definitions” CEN/TR 17620:2021 “Guidelines for selection, use, care and maintenance of smart garments protecting against heat and flame” CEN/CLC/TR 16832:2015 “Selection, use, care and maintenance of personal protective equipment for preventing electrostatic risks in hazardous areas” ISO 23616:2022 “Cleaning, inspection and repair of firefighters' personal protective equipment (PPE)” ISO/TR 21808:2021 “Guidance on the selection, use, care and maintenance of personal protective equipment (PPE) designed to provide protection for firefighters” ISO/ TS 20141:2022 “Guideline on compatibility of PPE” ISO/WD 20384 “Medical gowns, surgical drapes and protective apparel — Performance requirements, performance levels and test methods” ISO/CD 24588 “Protective clothing - Personal protective ensembles for use against chemical, biological, radiological and nuclear (CBRN) agents - Classification, performance requirements and test methods” Regulations: Regulation (EU) 2016/425 on Personal Protective Equipment EU 2016/ 425, Directive 89/ 656 EEC, Regulation EU 2017/ 745, Regulation EC 1907/2006 (REACH), Directive 2011/65/EU (RoHS), Directive 2014/34/EU (ATEX), Directive 2014/30/EU (EMC). Additional EU legislation may also apply depending on the specific application or construction of the PPE. Policies: EU Green deal (https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en) Annex II: List of documents under development in ISO TC94 SC14 ISO/AWI 11999-1 “PPE for firefighters — Test methods and requirements for PPE used by firefighters who are at risk of exposure to high levels of heat and/or flame while fighting fires occurring in structures — Part 1: General” ISO/AWI 11999-2 “PPE for firefighters — Test methods and requirements for PPE used by firefighters who are at risk of exposure to high levels of heat and/or flame while fighting fires occurring in structures — Part 2: Compatibility” ISO/AWI 11999-3 “PPE for firefighters — Test methods and requirements for PPE used by firefighters who are at risk of exposure to high levels of heat and/or flame while fighting fires occurring in structures — Part 3: Clothing” ISO/AWI 11999-4 “PPE for firefighters — Test methods and requirements for PPE used by firefighters who are at risk of exposure to high levels of heat and/or flame while fighting fires occurring in structures — Part 4: Gloves” ISO/AWI 11999-5 “PPE for firefighters — Test methods and requirements for PPE used by firefighters who are at risk of exposure to high levels of heat and/or flame while fighting fires occurring in structures — Part 5: Helmets” 9 ISO/AWI 11999-6 “PPE for firefighters — Test methods and requirements for PPE used by firefighters who are at risk of exposure to high levels of heat and/or flame while fighting fires occurring in structures — Part 6: Footwear” ISO/AWI 5056-1 “Personal protective equipment for firefighters undertaking specific rescue activities (Surface Water and Unstable Surface rescue) — Part 1: General” ISO/AWI 5056-2 “Personal protective equipment for firefighters undertaking specific rescue activities (Surface Water and Unstable Surface rescue) — Part 2: Compatibility” ISO/AWI 5056-3 “Personal protective equipment for firefighters undertaking specific rescue activities (Surface Water and Unstable Surface rescue) — Part 3: Clothing” ISO/AWI 5056-4 “Personal protective equipment for firefighters undertaking specific rescue activities (Surface Water and Unstable Surface rescue) — Part 4: Gloves” ISO/CD 24588 “Protective clothing. Personal protective ensembles for use against chemical, biological, radiological and nuclear (CBRN) agents. Classification, performance requirements and test methods” ISO 18639-4:2018/DAmd 1 “PPE ensembles for firefighters undertaking specific rescue activities — Part 4: Gloves — Amendment 1” 10 Informative Annex 1 "Principal categories of market needs" - Consumer protection and welfare - Environment - Innovation - Support to: -public policy -European legislation/regulation - Market access/barriers to trade, i.e. enhancing the free movement of: - services - goods - people - Interoperability - Health/Safety - Terminology Informative Annex 2 "Principal categories of stakeholders" - Industry and commerce, where particularly appropriate, to be identified separately as - Large enterprises (those employing 250 staff or more) - Small and medium sized enterprises (SME), (those employing 250 staff or fewer) - Government - Consumers including those organizations representing interests of specific societal groups, e.g. people with disabilities or those needing other particular consideration) - Labour - Academic and research bodies - Non-governmental organisations (NGO), including organizations representing broad or specific environmental interests - Standards application business (e.g. testing laboratories, certification bodies) Sometimes it is valuable also identify the immediate affected stakeholders from industry and commerce in terms of their position in a product value chain, as follows: - Supplier - Manufacturer - Intermediary (e.g. warehousing, transport, sales) - Service provider - User of the product or service - Maintenance / disposal NOTE: ‘Immediately affected stakeholders’ are considered to be those who, within the context of the proposal, would be in a position to implement the provisions of the intended standard(s) into their products, services or management practices. Informative Annex 3 "List of Abbreviations" AG General Assembly of CEN AI Authorized Inspector regularly employed by an ASME accredited Authorized Inspection AIS Authorized Inspector Supervisor. AM Amendment ANEC European Association for the coordination of consumer representation in standardization (an Associate of CEN) ASB Associated Body ATEX Explosive Atmospheres AWI Approved Work Item BOSS Business Operations Support System BT Technical Board (of CEN) BT TCMG Technical Board Technical Committee Management Group CA Administrative Board (of CEN) 11 CCB CEN Certification Board CD Committee Draft CEN European Committee for Standardization Comité Européen de Normalisation Europäisches Komitee für Normung (the acronym is invariable) CENELEC European Committee for Electrotechnical Standardization CEN/TR Technical Report CEN/TS Technical Specification CMC CEN Management Centre CWA CEN Workshop Agreement dav Date of Availability dam Draft amendment DE Design Engineer. DM Design Manager. doa Date of Announcement dop Date of Publication dor Date of Ratification dow Date of Withdrawal DIS Draft international standard DTR Final Draft technical report DTS Final Draft technical specification EC European Commission EEA European Economic Area EFTA European Free Trade Association ECOS European Environmental Citizens Organisation for Standardisation (and Associate of CEN) ENAPS Environmental Aspects in Product Standards EN European Standard ENV European Prestandard EOTA European Organization for Technical Approvals EOTC European Organisation for Conformity Assessment ESO European Standards Organizations ETUI-REHS European Trade Union for Research, Education, and Health and Safety (an Associate of CEN) EUCOMED European Confederation of Medical Devices Associations (an Associate of CEN) FIEC European Construction Industry Federation (an Associate of CEN) FDAM Final Draft amendment FDIS Final Draft international standard FprEN Final Draft European Standard for formal vote ICS International Classification for Standards (managed by ISO and also used by CEN) ICTSB Information and Communications Technology Steering Board IPR Intellectual Property Rights ISO International Organization for Standardization ISSS (CEN) Information Society Standardization System JCG Joint ISO/CEN Co-ordinating Group of the Technical Boards JPG Joint Presidents Group CEN/CENELEC/ETSI JTC Joint Technical Committee JWG Joint Working Group MDR Manufacturers (Partial) Data Report (not to be mistaken for Manufacturers Design Report). MTR Material Test Report. NCR Nonconformity Report. NORMAPME European Office of Crafts, Trades and Small and Medium-sized Enterprises for Standardization (Associate CEN) NP New proposal NSB National Standards Body NWI New Work item PAS Publicly Available Specification PC Project Committee PD Published Document PDTR Preliminary draft technical report PDAM Preliminary draft amendment PQ Primary Questionnaire PQP Project Quality Plan prEN draft European Standard prENV draft European Prestandard prTR draft Technical Report 12 prTS draft Technical Specification PWI Preliminary Work item SABE Strategic Board on Environment (CEN advisory group) SC Subcommittee SD Standards Distribution SF Sector Forum SR Systematic review STAR Standardization and Research & Development (CEN advisory group) TC Technical Committee TCG Terminology co-ordination group TF Task Force TR Technical Report TS Technical Specification UAP Unique Acceptance Procedure UQ Updating Questionnaire WD Working Draft WG Working Group 13 Saatja: Käti Liiv <[email protected]> Saadetud: 02.06.2023 15:25 Adressaat: <[email protected]>; <[email protected]>; <[email protected]>; <[email protected]>; <"SM Info">; <[email protected]>; <[email protected]>; <=?Windows- 1252?Q?Mariko_M=E4nna?=>; <[email protected]>; <[email protected]> Teema: CEN-CENELEC uue loodava komitee asutamisettepanek - Isikukaitsevahendite horisontaalsed teemad Manused: image001.jpg; 2023_c065_BT_N_14200.pdf Tere! Olen Eesti Standardimis- ja Akrediteerimiskeskuse koordinaator Käti Liiv ning pöördun teie poole seoses Euroopa Standardimiskomiteest (CEN) ja Euroopa Elektrotehnika Standardimiskomiteest (CENELEC) tulnud ettepanekuga, asutada uus CEN-CENELEC ühine tehniline komitee nimega „Isikukaitsevahendite horisontaalsed teemad” “Horizontal topics for Personal Protective Equipment (PPE)” Ettepaneku on teinud Briti standardimisorganisatsioon BSI. Täpsema info leiate manuses olevast ettepanekust. Uudis on leitav ka EVS-i kodulehel. Lühidalt komitee eesmärgiks on standardida alljärgnevaid horisontaalseid teemasid: o Standardite ja muude CEN/CENELEC – ISO/IEC dokumentide haldamine. Samuti nende standardite vastuvõtmine, mille varem töötasid välja CEN-CLC JWG-d või ISO asutused, mida CEN ei peegeldanud. o Kahe funktsiooniga isikukaitsevahend, o Nutikate tekstiilide/elektroonika või (muude) kantavate esemete integreerimine, o Koosmõju / isikukaitsesüsteemid (Personal Protective Systems), o Keskendumine konkreetsetele sektoritele või ohtudele, o Isikukaitsevahendite jätkusuutlikkus, o Isikukaitsevahendite süsteemide ergonoomika ja mugavus. Tunneme huvi teie seiskoha vastu antud komitee asutamise osas. 1. Kas valdkonna standardimine on vajalik? 2. Kas pakutud käsitlusala on piisav? 3. Kas ja mil määral oleksite huvitatud ISO komiteetöös ja standardite koostamises osalemisest? Tagasiside on oodatud kuni 07.07.2023 kuupäevaks. Vastan meeleldi ka täiendavatele küsimustele. Kui leiate, et käesolev info ei ole jõudnud olulise huvipooleni, võib käesolevat infot jagada või puudunud kontaktidest teavitada. Heade soovidega Käti Liiv Standardimiskoordinaator / Coordinator of standardisation +372 53 630 663 [email protected] www.evs.ee https://www.facebook.com/EVS.Standard
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