Business sectors

A new technical committee, CEN-CLC/JTC 23 ‘Horizontal topics for Personal Protective Equipment (PPE)’, was established at the end of 2023. This joint TC will work on standards that encompass more than one type of PPE product. In 2024, the intention is to carry out standardization activities in the following Horizontal topics (although the below is a non-exhaustive list):

• Maintenance and/or adoption of standards and/or other CEN and CENELEC - ISO/IEC deliverables which in the past were developed by CEN and CENELEC Joint Working Groups or by ISO bodies not mirrored in CEN;
• Dual function PPE;
• Integration of smart textiles/ electronics or (other) wearables;
• Ensembles and Personal protective systems (PPS);
• Focus on specific sectors or hazards;
• Sustainability in PPE;
• Ergonomics and comfort of PPE systems.

Furthermore, CEN/TC 162 ‘Protective clothing including hand and arm protection and lifejackets’ will work on the fulfilment of Mandate M/571 for standardization activities under the PPE Regulation (EU). The group foresees to publish EN 14404-series on ‘Knee protectors for work in the kneeling position’, parts 1 to 6.

The same TC is also closely working together with ISO/TC 94/SC 13 ‘Protective clothing’ to develop EN ISO standards in the area of protective gloves: among them, the EN ISO 374-series on ‘Protective gloves against dangerous chemicals and micro-organism’. In addition, in 2024 it will also review several standards of the EN 14225-series specifying the performance of diving suits for wear by divers for underwater activities.

Finally, CEN/TC 162 will also have a closer look on how to include sustainability aspects in the daily work on PPE-standardization.

Another TC active in this sector is CEN/TC 158 'Head protection’. Its most important work in 2024 is to finalise the revision of EN 17950 ‘Protective helmets - Test methods - Shock absorption including measuring rotational kinematics’. This document specifies a new headform used in product standards testing, including requirements for oblique impact, such as EN 1078 'Helmets for cyclists' and EN 1080 'Impact protection for young children'.

Other activities will include the finalization of the revision of the EN ISO 10256 series 'Protective equipment for use in ice hockey' Part 1-4 in parallel with ISO/TC 83 ‘Sports and other recreational facilities and equipment’.

Finally, the TC is also committed to finalise EN 397, which specifies physical and performance requirements, methods of test and marking requirements for industrial safety helmets and will further work on the revision of EN 12492 'Helmets for mountaineers' and a new standard for 'Helmets for ski mountaineers'.

Following the revision of the Machinery Regulation, CEN/TC 122 ‘Ergonomics’ and in particular its Working Group 2 ‘Ergonomic design principles’ will start the revision of EN 614 series ‘Safety of machinery - Ergonomic design principles’ starting with Part 1 ‘Safety of machinery - Ergonomic design principles - Part 1: Terminology and general principles’.

At the same time, CEN/TC 122’s WG 1 ‘Anthropometry’ will continue working on a project, funded by the European Commission, on anthropometric and strength data of children. Anthropometric and strength data are not only a crucial basis for health and safety requirements in standards and inclusion. They are also very important for the design of ergonomic and safe products (such as face masks), workplaces and domestic/public environments. In 2024, the WG intends to pursue the development of a Technical Report containing the outcome of surveys collecting anthropometric data of children.

Working Group 1 also plans to launch another project on anthropometric and strength data of adults, with a focus on making standards inclusive and gender responsive. The intention is to start a first project phase in 2024: it will consist of research on data needs and on data availability, a gap analysis, and the preparation of a future survey to obtain still missing data.

Finally, CEN/TC 161 ‘Foot and leg protectors’ will revise all work sector specific footwear standards such as prEN 15090 rev ‘Footwear for firefighters’ and prEN ISO 17249 rev ‘Safety footwear with resistance to chain saw cutting’.
In addition, it expects to start working on some brand-new topics including a standard for socks (hose) with protective functions and a standardised whole shoe test procedure to measure breathability. A new project on ‘slip resistance on ice and overshoes’ will also be launched.

MEDICAL DEVICES

CEN/TC 204 ‘Sterilization of medical devices’ will continue to support the development of harmonized standards to support manufacturers aiming to build products compliant with the Medical Devices and In Vitro Diagnostic Regulations. The TC will also mirror ISO/TC 198 ‘Sterilization of health care products’ on key projects such as:

• EN ISO 17664-2 ‘Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices’;
• EN ISO 11135 ‘Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices’;
• EN ISO 11137 series ‘Sterilization of health care

products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices’.
The EN 556 series ‘Sterilization of medical devices - Requirements for medical devices to be designated "STERILE"’ will also be published in 2024.

Another TC active in this sector, CEN/TC 102 'Sterilizers and associated equipment for processing of medical devices', in 2024 will work on the following documents:

• The first edition of EN 17180 ’Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing’;
• The revision of EN 14180 ‘Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’;
• The revision of EN 1422 ‘Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods’.

Three of TC 102’s Working Groups, WG 4 ‘Packaging’, WG 7 ‘Biological and chemical indicators’, and WG 8 ‘Washer-disinfectors’ will support the revision of:

• EN ISO 11607 series ‘Packaging for terminally sterilized medical devices’;
• EN ISO 11138 ‘Sterilization of health care products - Biological indicators’;
• The EN ISO 11140 ‘Sterilization of health care products - Chemical indicators’ and EN ISO 15883 ‘Washer-disinfectors’ series to meet the requirements of the MDR and develop the Annexes Z.

Moreover, CEN/TC 102 expects to finalize the below standards over the course of 2024:

• EN 14180 'Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing’;
• EN 17180 ’Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing’;
• EN 13060 'Small steam sterilizers';
• EN ISO 15883-2 ‘Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices’;
• EN ISO 15883-3 ‘Washer-disinfectors — Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers’;
• EN ISO 11139 ‘Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1’.

CEN/TC 140 ‘In vitro diagnostic medical devices’ intends to complete the following standards by 2024:

• The EN ISO 18113-series ‘In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling)’;
• FprEN ISO 20916 ‘In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice (ISO 20916:2019)’.

Finally, CEN/TC 206 ‘Biological and clinical evaluation of medical devices’ will continue with the revision of several standards of the EN ISO 10993 series. This series lays down the general principles governing the biological evaluation of medical devices within a risk management process.

RESPIRATORY AND ANAESTHETIC EQUIPMENT

CEN/TC 215 ‘Respiratory and anaesthetic equipment’ will develop some key standards. Among them, it expects to make headways on a new project, ISO 80601-2-93 ‘Medical electrical equipment - Part 2-93: Particular requirements for basic safety and essential performance of inhalational therapy nebulizer equipment’.
The Committee will also launch the development of harmonized standards to include in Annex Z specifically for:

• ISO EN 5359 ‘Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases’;
• and EN ISO 18562 series on ‘Biocompatibility evaluation of breathing gas pathways in healthcare applications’.
  The aim is to support manufacturers to develop products in compliance with the Medical Device Regulations. Ongoing standardization activities within the portfolio of the TC will be further developed in 2024.

CHEMICAL DISINFECTANTS AND ANTISPETICS

CEN/TC 216 ‘Chemical disinfectants and antiseptics’ works on the development of harmonized standards under the Medical Devices Regulation (EU)2017/745. Among them, in 2024 it expects to finalize and publish as a harmonized standard the general transversal standard EN 14885 ‘Chemical disinfectants and antiseptics - Application of European Standards for chemical disinfectants and antiseptics’.
In addition, the TC will start the revision of the following standards:

• EN 13624 ‘Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area - Test method and requirements (phase 2, step 1)’;
• EN 14348 ‘Chemical disinfectants and antiseptics -Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants - Test methods and requirements (phase 2, step 1)’;
• EN 14561 ‘Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area - Test method and requirements (phase 2, step 2)’.

ASSISTIVE PRODUCTS AND ACCESSIBILITY

CEN/TC 293 ‘Assistive products and accessibility’ will continue to develop standards in cooperation with ISO/TC 173 ‘Assistive products’ under the Vienna Agreement. One of the standards it will work on in 2024 is prEN ISO 15621 ‘Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation’.

Moreover, its Working Group 12 ‘Accessibility’ will continue working on prEN 17999 ‘Accessible systems for living independently — Requirements and recommendations’, which specifies requirements and provides guidance on aspects of accessible systems for living independently in relation to technical solutions, service design, provision, and information. This includes adapting the design and functionality of systems to allow ease of use by any user, regardless of their abilities. At the same time, Working Group 13 ‘Tactile lettering’ will start working on ‘Tactile lettering — Requirements on the presentation and application of Braille and raised lettering’.