Business sectors

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 Coordination Group on Personal Protective Equipment (CEN-CLC/COG PPE). The CEN-CLC/COG PPE gathers PPE expertise and coordinates a common approach for the Technical Committees concerned, especially regarding how to deal with future developments efficiently and coherently. The coordination also includes handling different legislation affecting the PPE market and standardization, such as the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the Waste Directive, and the consolidation of challenges with European and international market requirements.

One of the COG’s 2026 priorities is to continue pursuing the alignment of existing standards with the PPE Regulation (EU) 2016/425 and coordinate the development and revision of (harmonized) standards in response to the PPE standardization request M/571. This will ensure the smooth citation of these 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 health and safety requirements of the PPE Regulation.

CEN/TC 79 ‘Respiratory protective devices’ will further the development of prEN 137 ‘Respiratory protective devices – Self-contained open-circuit compressed air breathing apparatus with full face mask – Requirements, testing, marking’ and  prEN 13794 ‘Respiratory protective devices – Self-contained closed-circuit breathing apparatus for escape – Requirements, testing and marking’ in support of the Personal Protective Equipment (PPE)  Regulation (EU) 2016/425 and its corresponding standardization request (M/571).

CEN/TC 158 ‘Head Protection’ is developing a new standard titled ‘Helmets for users of S-EPACs or other high speed cycles’, following a request from the European Commission. This initiative responds to the growing presence of Speed-Electrically Power Assisted Cycles (S-EPACs) on the market and the current lack of a standard for an appropriate helmet for their users. The standard will support the implementation of the Personal Protective Equipment (PPE) Regulation (EU) 2016/425.

CEN/TC 158 will also explore the development of a potential standard for protective headgear used in football and other sports with similar risks of head trauma. Several studies have highlighted a rising incidence of concussions among football players, and there is growing societal concern that repeated head impacts may contribute to dementia.

Additional activities planned for 2026 include the revision of EN 443 ‘Helmets for fire fighting in buildings and other structures’ and EN 966 ‘Helmets for airborne sports’.

CEN/TC 158 plans to publish new editions of:

• EN 1078 ‘Helmets for cyclists’
• EN 1080 ‘Impact protection for young children’

They will be the first product standards to include pass/fail criteria for oblique impact testing, using headforms and the new test method defined in EN 17950:2024 ‘Protective helmets – Test methods – Shock absorption including measuring rotational kinematics’.

CEN/TC 159 ‘Hearing protection’ has completed the revision of EN 458 ‘Hearing protectors – Recommendations for selection, use, care and maintenance – Guidance document’, and the new version is expected to be published in 2026. The revision covers the following aspects:

• the implications of the PPE Regulation (EU) 2016/425 that specifies hearing protection as Category III PPE;
•  the revision of the EN 352 series and the EN 13819 series (Requirements and testing procedures for hearing protectors);
• the growing relevance of individual fit testing (see EN 17479 ‘Hearing protectors – Guidance on selection of individual fit testing methods’).

CEN/TC 160 ‘Protection against falls from height including working belts’ will focus on revising the standards listed under the PPE standardization request for harmonization in support of the Personal Protective Equipment Regulation (EU) 2016/425. The following standards will be revised:

• prEN 795 ‘Personal fall protection equipment – Anchor devices’
• prEN 341 ‘Personal fall protection equipment – Descender devices for rescue’

CEN/TC 161 ‘Foot and leg protectors’ will focus on the revision of:

• prEN 13832 series on ‘Footwear protecting against chemicals’
• prEN 15090 ‘Footwear for firefighters’
• prEN ISO 17249 ‘Safety footwear for users of handheld chain saws’

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 to work on fulfilling Mandate M/571, covering the mandated projects under the PPE Regulation. Extending the deadline for the Standardization Request until 30 April 2029 is currently under amendment. This ongoing amendment will also include the development of new standardization topics proposed by the PPE Expert Group of the European Commission, such as surface wetsuits.

As climate change intensifies, there is an increasing need to ensure adequate protection for outdoor workers against heat stress, natural UV radiation, and other environmental factors. To address these challenges, CEN/TC 162 WG 4 is prepared to develop standards for protective clothing incorporating cooling features. In this context, close cooperation with CEN/TC 248 ‘Textiles and textile products’ to define UV-protective properties for textiles will be established.

Several ongoing standardization activities within CEN/TC 162 will continue in 2026:

• In the area of body protection for sports, the following documents will be further developed:
• EN 13158 series on protective garments for equestrian activities, including requirements for protective jackets, incorporation of airbags and test methods;
• EN 13159 series on back protectors for equestrian use, including requirements for incorporation of airbags and specifying test methods.
• The EN ISO 16602 series, setting requirements for protective clothing for protection against chemicals, will be prepared for Formal Vote. The 6 parts of this series will integrate insights from existing documents like ISO 17723-1, ISO 13982-2, EN 13034, EN 14605, the EN 943 series, EN 14325, and EN 1073 and provide a modular approach for chemical protection. This series will provide identical requirements and test methods for the European and international level and will support the PPE Regulation.
• EN ISO 10256-5 ‘Protective equipment for use in ice hockey – Part 5: Neck laceration protectors for use in ice hockey’ is scheduled to be published in 2026.
• EN ISO 13997 ‘Determination of resistance to cutting by sharp objects’ will be reallocated to CEN/TC 162 WG 8 ‘Protective gloves’ for European contributions to this project.

CEN/TC 102 'Sterilizers and associated equipment for processing of medical devices' is working on the development of standards listed under the Standardization Request M/575 for harmonization under the Regulations (EU) 2017/745 and 2017/746.

The following standards will be proposed for citation in the Official Journal of the European Union (OJEU):

• EN 14180:2025 ‘Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’
• EN 13060 ‘Sterilizers for medical purposes – Small steam sterilizers – Requirements and testing’
• Parts 1, 2, 3 and 7 of the EN ISO 15883 series on washer-disinfectors 

The following ongoing standardization activities will be further developed in 2026:

• EN 868 parts 5, 8, 9, and 10 on ‘Packaging for terminally sterilized medical devices’ will be revised by CEN/TC 102 WG 4 ‘Packaging’.
• CEN/TC 102 WG 5 ‘Steam sterilizers’ will discuss the revision of EN 285 ‘Sterilization – Steam sterilizers – Large sterilizers’.
• CEN/TC 102 WG 6 ‘Low temperature sterilizers’ will continue to work on EN 17180 ’Sterilizers for medical purposes – Low temperature vapourized hydrogen peroxide sterilizers – Requirements and testing’, which will be a first edition. The revision of EN 1422 ‘Sterilizers for medical purposes – Ethylene oxide sterilizers – Requirements and test methods’ will continue as well.
• CEN/TC 102 WG 7 ‘Biological and chemical indicators’ and CEN/TC 102 WG 8 ‘Washer-disinfectors’ are actively supporting the revision of the EN ISO 11138 ‘Sterilization of health care products – Biological indicators’ series and the EN ISO 11140 ‘Sterilization of health care products – Chemical indicators’ series, as well as the EN ISO 15883 ‘Washer-disinfectors’ series to meet the requirements of the Medical Devices Regulation (MDR) and develop the Annexes Z to show the relationship between the European standard and the General Safety and Performance Requirements of the MDR.

CEN/T 205 ‘Non-active medical devices’ is developing European standards but also supporting the development of EN ISO standards from different areas, such as 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’, ISO/TC 121 ‘Anaesthetic and respiratory equipment’, ISO/TC 150 ‘Implants for surgery’, and ISO/TC 157 ‘Non-systemic contraceptives and STI barrier prophylactics’.

Some of them are listed in the Medical Devices Standardization Request (M/575) as candidates for harmonization under the Medical Devices Regulation (EU) 2017/745 (MDR) and the Personal Protective Equipment (PPE) standardization request (M/571) in support of the PPE Regulation (EU) 2016/425.

CEN/TC 205 will further develop the following ongoing standardization activities in 2026:

• EN 455-3/A1 ‘Medical gloves for single use – Part 3: Requirements and testing for biological evaluation’, developed in WG 3 ‘Medical gloves’
• EN 455-4 ‘Medical gloves for single use – Part 4: Requirements and testing for shelf life determination’, developed in WG 3 ’Medical gloves’
• The EN 18178 series ‘Respiratory infection prevention devices for self- and third-party protection’, developed in WG 17 ‘Infection protection masks’

CEN/TC 206 ‘Biological and clinical evaluation of medical devices’ supports the development of the EN ISO 10993 series on ‘Biological evaluation of medical devices’ as well as of EN ISO 14155 ‘Clinical investigation of medical devices for human subjects – Good clinical practice’. These standards are listed in the Medical Devices Standardization Request (M/575) as candidates in support of the Medical Devices Regulation (EU) 2017/745. A new WG 2 ‘Annex ZA focus group’ was therefore created to better coordinate this work.

In addition, the following new projects were added to the work programme of CEN/TC 206:

• prEN ISO 21762 ‘Medical devices utilizing human tissues and their derivatives – Application of risk management’
• prEN ISO 18969 ‘Clinical evaluation of medical devices’
• prEN ISO 8250 ‘Cleanliness of medical devices – Process design and test methods’

CEN/CLC/JTC 3 ‘Quality management and corresponding general aspects for medical devices’ will focus on the revision of FprEN ISO 80369-1 ‘Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements (ISO/FDIS 80369-1:2025)’ in support of the Medical Devices Regulation (2017/745/EU) and its corresponding Standardization Request M/575.

CLC/TC 62 ‘Electrical equipment in medical practice’ will discuss advancing its medical devices artificial intelligence (AI) standards towards harmonization, while also initiating work on computational modelling standards. These activities will represent the technical committee’s main priorities, alongside the harmonization of standards related to the IEC 60601-1 series on ‘Medical electrical equipment’ and other horizontal base standards for active medical devices.

CEN TC 293 develops standards on ‘Assistive products and accessibility’. Assistive products are mainly used by individuals with disabilities and older adults. These users often have specific needs due to impairments in sensory and physical functions or cognitive functions, for example.

The assistive products sector involves a wide range of stakeholders, including consumers, attendants, manufacturers, government bodies, purchasers, healthcare and social welfare professionals, testing laboratories, and research and educational institutions.

In 2026, CEN/TC 293 will continue to develop standards in cooperation with ISO/TC 173 ‘Assistive products’ under the Vienna Agreement.

The following documents are expected to be published as EN ISO standards in 2026:

• prEN ISO 17966 ‘Assistive products for toileting, bathing and showering – Requirements and test methods’ (previously only ISO standard)
• prEN ISO 15621 ‘Absorbent incontinence products for urine and/or faeces – General guidelines on evaluation’

Ongoing standardization activities that will be further developed in 2026 are the following:

• Smart mobility for persons with reduced mobility – Functional approaches
• prEN 18156 ‘Tactile lettering – Requirements on the presentation and application of Braille and raised characters’

CEN/TC 293 will also continue its work on preparing standards for MDR harmonization in support of the Medical Devices Regulation (2017/745/EU) and its corresponding Standardization Request M/575.

Standards for prostheses and orthoses, wheelchairs, hoists, and general requirements for assistive products are included.