Health
CEN/TC 231 ‘Mechanical vibration and shock’ will work on EN ISO 5349-3 ‘Mechanical vibration – Measurement and evaluation of human exposure to hand-transmitted vibration – Part 3: Isolated and repeated shocks using the frequency range of ISO 5349-1’. This work is primarily driven by the industry, with stakeholders from occupational health and safety, public service, and manufacturers of hand-held, hand-guided, and mobile machinery expected as the users of the standard. It will provide the industry with a reliable method for measuring repeated shock vibration. Given its international relevance, this standard will be critical for manufacturers of hand-held, hand-guided, and mobile machinery seeking to sell their products in the European Union. The standard will be developed in support of Machinery Regulation (EU) 2023/1230, in cooperation with ISO.
Personal Protective Equipment (PPE): other
CEN/TC 159 ‘Hearing protectors’ will continue revising its main standard prEN 458 on the selection, use, care, and maintenance of hearing protectors.
The revision not only aligns EN 458 with the updated standard series EN 352 for hearing protectors falling under the Personal Protective Equipment Regulation (EU) 2016/425, but it also updates EN 458 to fit testing methods for hearing protectors described in EN 17479 ‘Hearing protectors – Guidance on selection of individual fit testing methods’. EN 458 is extended with a new annex that provides guidance on sustainability, taking into account the different responsibilities within organizations, such as sourcing, safety, supervision, and correct use. The standard is also intended to guide employers, supervisors, and safety advisors. Additionally, it gives information to all who need to use hearing protectors.
CEN/TC 160 ‘Protection against falls from height including working belts’ will focus on revising its standards listed under the PPE standardization request for harmonization in support of the Personal Protective Equipment Regulation (EU) 2016/425. These revisions will include:
- prEN 355 rev ‘Personal fall protection equipment – Energy absorbers’
- prEN 361 rev ‘Personal fall protection equipment – Full body harnesses’
CEN/TC 161 ‘Foot and leg protectors’ will focus on the revision of prEN 13832 rev ‘Footwear protecting against chemicals’ series. The Technical Committee will also work on prEN ISO 17249 ‘Safety footwear for users of handheld chain saws (ISO/DIS 17249:2024)’ and prEN 15090 ‘Footwear for firefighters’. These standards will be developed in support of the Personal Protective Equipment Regulation (EU) 2016/425 and its corresponding mandate (M/571).
CEN/TC 162 ‘Protective clothing including hand and arm protection and lifejackets’ will continue its work to fulfil the Personal Protective Equipment Mandate (M/571) by advancing projects that support the PPE Regulation.
CEN/TC 162 will also advance its work on a standard for ‘Warning Clothing with Active Lighting’. This new initiative will complement prEN ISO 20471 rev ‘High visibility clothing – Test methods and requirements’ and EN 17353:2020/prA1 - ‘Protective clothing – Enhanced visibility equipment for medium risk situations – Test methods and requirements’, focusing on equipment for active luminous warning clothing, with specific attention to developing test methods and requirements. Additionally, the Technical Committee, together with ISO, will start working on EN ISO 10256-5 ‘Protective Equipment for Use in Ice Hockey – Part 5: Neck Laceration Protectors’.
For the standard on motorcyclists’ protective clothing against mechanical impact, different parts of the EN 1621 series will be initiated.
In the field of body protection for sports, the following standards will be developed:
- EN 13158 ‘Protective clothing – Protective jackets, body and shoulder protectors for equestrian use, for horse riders and those working with horses, and for horse drivers – Requirements and test methods’ will be expanded to a series of three standards for protective garments for equestrian activities, including requirements for protective jackets, incorporation of airbags and test methods;
- a new series of EN 13159 with three parts of standards for back protectors for equestrian use, including requirements for incorporation of airbags and specifying test methods, will be initiated.
Additionally, the Technical Committee is working closely with ISO/TC 94/SC 13 ‘Protective clothing’ to develop EN ISO standards:
- in the area of protective gloves, they are working on the EN ISO 374 series on ‘Protective gloves against dangerous chemicals and micro-organism’, finalizing parts 1, 5 and 6;
- work will restart on the EN ISO 16602 series on ‘Protective clothing for protection against chemicals’, setting requirements for protective clothing for protection against chemicals. The six parts of this series will integrate the takeaways from other existing documents and establish identical requirements and test methods at both the European and international levels, supporting the PPE Regulation.
CEN/TC 162 ‘Protective clothing including hand and arm protection and lifejackets’ will also have a closer look on how to include sustainability aspects in PPE standardization and how this can be included in daily standardization. The Technical Committee is also reviewing its business plan with the focus to include future trends like sustainability and digitalization.
Medical devices
CEN/TC 102 'Sterilizers and associated equipment for processing of medical devices' is actively working on the development of standards listed under the Medical Device Standardization Request (M/575) in support of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).
Regarding the ongoing standardization activities planned for further development in 2025, CEN/TC 102 will focus on revising EN 868 ‘Packaging for terminally sterilized medical devices’ parts 2, 3, 4, 6, and 7, with the revision of parts 5, 8, 9, and 10 to follow.
Furthermore, EN 13060 ‘Sterilizers for medical purposes – Small steam sterilizers – Requirements and testing’ will be further revised to meet the requirements of the MDR.
For EN 14222 ‘Stainless steel steam boilers’, an amendment in accordance with the MDR and the Pressure Equipment Directive (PED) (2014/68/EU) is also under development.
Additionally, the TC will work on a new project: EN ISO 19253 ‘Sterilization of health care products – Application of ISO/TS 22421 to the requirements for sterilizers used for the terminal sterilization of health care products containing aqueous liquid in sealed containers’.
Furthermore, CEN/TC 102 will work on EN 17180 ’Sterilizers for medical purposes – Low temperature vapourized hydrogen peroxide sterilizers – Requirements and testing’, which will be the first edition of the standard. The working group will also focus on the revision of EN 14180 'Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’, as well as prEN 1422 rev ‘Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods’.
In addition, the TC will continue working on the revision of EN ISO 11138 ‘Sterilization of health care products – Biological indicators’ and the EN ISO 11140 series on ‘Sterilization of health care products – Chemical indicators’, as well as the EN ISO 15883 series on ‘Washer-disinfectors’ to meet the requirements of the MDR.
Still under the portfolio of CEN/TC 102, the standards listed below are expected to be completed in 2025:
- EN 868 series on ‘Packaging for terminally sterilized medical devices’, parts 2, 3, 4, 6, 7;
- EN ISO 15883-2 series on ‘Washer-disinfectors’, parts 2,3, 7;
- EN 1422 ‘Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods’;
- EN 14180 'Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’;
- EN 17180 ’Sterilizers for medical purposes – Low temperature vapourized hydrogen peroxide sterilizers – Requirements and testing’;
- EN 13060 'Small steam sterilizers'.
CEN/TC 215 ‘Respiratory and anaesthetic equipment’ will explore the adoption of new international work in the following areas:
- ‘Facemasks for ventilation of patients’: this is a new international work item requiring a lot of consideration due to the large number of different masks on the market;
- ‘Anaesthetic and respiratory equipment – Waste volatile anaesthetic agent capture systems’: this standard is intended to improve safety for patients and clinicians while also reducing the environmental impact of anaesthetic agents which are potent greenhouse gases;
- ‘Cryogenic storage systems with automated nitrogen supply systems – Design, installation, and testing of Cryogenic Pipeline Systems’: it addresses a category of pipeline installations that currently have no particular standard to provide recommendations.
In parallel with these new initiatives, CEN/TC 215 will continue supporting the development of harmonized standards that meet the general safety and performance requirements of the Medical Device Regulation (EU) 2017/745 (MDR). This will enable manufacturers to benefit from a presumption of conformity that results from harmonization.
CEN/TC 205 'Non-active medical devices' will continue working on the following standards:
- the revision of the EN 455 series on 'Medical gloves for single use' to meet the requirements of the Medical Device Regulation (EU) 2017/745 (MDR), including the development of the first edition of EN 455-5 'Medical gloves for single use – Part 5: Extractable chemical residues';
- the development of the new series of standards on 'Respiratory infection prevention devices for self- and third-party protection', which consists of five parts. The first part of this standard, ‘Respiratory infection prevention devices for self- and third-party protection – Part 1: Requirements and marking’ will be developed in support of both the Medical Device Regulation (EU) 2017/745 (MDR) and the Personal Protective Equipment Regulation (EU) 2016/425.
Additionally, CEN/TC 205 will continue working together with ISO/TC 76 'Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use', ISO/TC 84 'Devices for administration of medicinal products and catheters', and ISO/TC 157 'Non-systemic contraceptives and STI barrier prophylactics' on the following harmonized standards in support of the Medical Device Regulation (EU) 2017/745 (MDR) and Standardization Request (M/575):
- EN ISO 4074 'Natural rubber latex male condoms – Requirements and test methods';
- EN ISO 3826-2 'Plastics collapsible containers for human blood and blood components – Part 2: Graphical symbols for use on labels and instruction leaflets';
- EN ISO 3826-3 'Plastics collapsible containers for human blood and blood components – Part 3: Blood bag systems with integrated features'.
CEN/TC 206 ‘Biological and clinical evaluation of medical devices’ is actively supporting the development of EN ISO 10993 ‘Biological evaluation of medical devices’ series, as well as EN ISO 14155 ‘Clinical investigation of medical devices for human subjects – Good clinical practice’. These standards are listed in support of the Medical Device Regulation (EU) 2017/745 and its mandate (M/575) for harmonization. In addition, the TC will work on the following new projects:
- prEN ISO 21762 ‘Medical devices utilizing human tissues and their derivatives – Application of risk management’ and
- prEN ISO 18969 ‘Clinical evaluation of medical devices’.
CEN/TC 239 ‘Rescue systems’ will develop prEN 1789-1 ‘Medical vehicles and their equipment – Road ambulances – Part 1: Requirements for medical devices‘ and prEN 1789-2 rev ‘Medical vehicles and their equipment – Road ambulances – Part 2: Operational and technical requirements’.
prEN 1789-1 rev will support the Medical Device Regulation (EU) 2017/745 and its Standardization Request (M/575), while prEN 1789-2 rev will support Regulation (EU) 2018/858 on the approval and market surveillance of motor vehicles and their trailers, as well as of systems, components, and separate technical units intended for such vehicles.
The key drivers for this work are industry, commerce, labour, and NGOs, with a broad range of stakeholders including SMEs, consumers, and government entities. These standards are expected to bring substantial benefits, such as enhancing the ergonomic design and safety of both medical crews and patients, while supporting the tendering process.
PERSONAL PROTECTIVE EQUIPMENT