Business sectors

Healthcare and Health Safety

Technical Bodies

CEN and CENELEC develop European Standards setting quality, performance, and safety requirements for a wide variety of medical devices and associated products, ranging from contact lenses through antiseptics to road ambulances, and including health informatics.

Standardization plays a fundamental role in this sector, as it ensures a high level of safety for patients and users of medical devices. It also guarantees that a device used in one country can also be used in any other country with the same results.

The CEN and CENELEC Sector Forum on Healthcare Standards (SFHS) will continue supporting CEN and CENELEC for the exploration of potential new areas for standardization in the medical field. In 2024, the Sector Forum will focus on guiding relevant Technical Committees (TCs) in the transition to the new landscape under the Medical Devices Regulation (MDR) (2017/745/ EU) and the In Vitro Medical Devices Regulation (IVDR) (2017/746/EU). The Forum also aims to facilitate discussions between stakeholders on harmonization issues to reduce ongoing concerns.

In addition, standardization on Personal Protective Equipment (PPE), such as protective helmets, ropes used to prevent falls from a height or footwear resistant to chemicals, is handled by Technical Committees that are part of the CEN and CENELEC Sector Forum on Personal Protective Equipment. One of the Sector Forum’s 2024 priorities is to pursue the alignment of existing standards with the PPE Regulation (EU) 2016/425 and coordinate the development and revision of standards supporting M/571 under said Regulation. This will ensure the smooth citation of those standards in the Official Journal of the European Union (OJEU). In turn, it will allow manufacturers, notified bodies and other stakeholders to use these standards to benefit from a presumption of conformity against the essential requirements of the PPE Regulation.

Following a Workshop on ‘Sustainability for PPE – addressing the challenges through standardization’ held in 2021, which highlighted the need for further coordination on the topic, a Task Group on Sustainability within the CEN and CENELEC PPE Sector Forum was created. The group aims to develop recommendations for standardization in the PPE sector on how to include sustainability and circularity in PPE standards. The Task Group Sustainability will interlink with the Circular Economy Task Group (CE-TG) of the CEN and CENELEC Advisory Body on Environment (SABE). To know more, see the chapter ‘Environment’.

Furthermore, the CEN Sector Forum on Occupational Health and Safety (SF OHS) is a platform for the exchange of information on European standardization activities related to various kinds of hazards in the workplace and health-related issues. It is closely linked to a variety of stakeholders: among them, the European Commission’s DG Employment, Social Affairs and Inclusion, EU-OSHA (European Agency for Safety and Health at Work), European employer and employee associations, national occupational health and safety representatives, the Technical Committees (TCs) which develop European standards and other Sector Fora connected to product standards with occupational health and safety aspects.

In 2024, SF OHS will focus on better identifying standardization projects on the prevention of occupational risks, health and safety protection, and the elimination of risk and accident factors. The body will also publish a so-called European Early Information System, so that the SECT/SF OHS members will be informed about relevant new projects as early as possible. In this way, they will be able to give OH&S advice to the standardization committees at an early stage of standardization work and engage experts on Occupational Health and Safety in the standardization work.

45 Technical Bodies responsible

CEN/CLC/JTC 16 Active Implantable Medical Devices
CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices
CEN/CLC/JTC 23 Horizontal topics for Personal Protective Equipment (PPE)
CEN/SS S02 Transfusion equipment
CEN/SS S03 Syringes
CEN/SS S30 Occupational health and safety management systems
CEN/SS S99 Health, environment and medical equipment - Undetermined
CEN/TC 102 Sterilizers and associated equipment for processing of medical devices
CEN/TC 122 Ergonomics
CEN/TC 137 Assessment of workplace exposure to chemical and biological agents
CEN/TC 140 In vitro diagnostic medical devices
CEN/TC 158 Head protection
CEN/TC 159 Hearing protectors
CEN/TC 160 Protection against falls from height including working belts
CEN/TC 161 Foot and leg protectors
CEN/TC 162 Protective clothing including hand and arm protection and lifejackets
CEN/TC 170 Ophthalmic optics
CEN/TC 204 Sterilization of medical devices
CEN/TC 205 Non-active medical devices
CEN/TC 206 Biological and clinical evaluation of medical devices
CEN/TC 215 Respiratory and anaesthetic equipment
CEN/TC 216 Chemical disinfectants and antiseptics
CEN/TC 231 Mechanical vibration and shock
CEN/TC 239 Rescue systems
CEN/TC 251 Health informatics
CEN/TC 285 Non-active surgical implants
CEN/TC 293 Assistive products and accessibility
CEN/TC 305 Potentially explosive atmospheres - Explosion prevention and protection
CEN/TC 362 Healthcare services - Quality management systems
CEN/TC 392 Cosmetics
CEN/TC 403 Aesthetic surgery and aesthetic non-surgical medical services
CEN/TC 469 Animal health diagnostic analyses
CEN/TC 470 Quality along the patient pathway in medical imaging
CEN/TC 55 Dentistry
CEN/TC 79 Respiratory protective devices
CEN/TC 85 Eye protective equipment
CEN/WS 068 Quality criteria for health checks
CEN/WS 102 CEN Workshop on guidelines for introducing tele-medical and pervasive monitoring technologies balancing privacy protection against the need for oversight and care
CEN/WS 118 Absorbent hygiene products - Test methods for analyzing trace chemicals
CEN/WS DHI Digital health innovations – Good practice guide for obtaining user consent for personal health information
CEN/WS EXOSK Integration process of new technologies of physical assistance such as exoskeletons
CLC/SR AAL Active Assisted Living
CLC/TC 31 Electrical apparatus for potentially explosive atmospheres
CLC/TC 62 Electrical equipment in medical practice
CLC/TC 78 Equipment and tools for live working

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.



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.


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.


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)’.


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’.

Standards published by CEN and CENELEC in the sector

  • CEN and CENELEC Portfolio of deliverables: 1743 ENs + 122 other deliverables
  • Work items currently in the Work Programme: 458 ENs + 21 other deliverables

Standardization requests from EC/EFTA

  • M/571 – Personal Protective Equipment
  • M/575 – Medical Devices

Further information