Commission Implementing Decision (EU) 2026/193 has been published, introducing a total of 12 new harmonised standards. These standards span a broad range of areas, including neurosurgical implants, sterilisation of healthcare products, and the biological evaluation of breathing gas pathways used in healthcare applications.
The full list of harmonised standards can be seen listed below;
- EN ISO 7197:2024: Neurosurgical implants – Sterile, single-use hydrocephalus shunts (ISO 7197:2024)
- EN ISO 10993-4:2017: Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) EN ISO 10993-4:2017/A1:2025
- EN ISO 14155:2020: Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020) EN ISO 14155:2020/A11:2024
- EN ISO 14630:2024: Non-active surgical implants – General requirements (ISO 14630:2024)
- EN ISO 17665:2024: Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
- EN ISO 18562-1:2024: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024)
- EN ISO 18562-2:2024: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024)
- EN ISO 18562-3:2024: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances (ISO 18562-3:2024)
- EN ISO 18562-4:2024: Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
- EN ISO 21535:2024: Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2023)
- EN ISO 21536:2024: Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023)
- EN ISO 80369-2:2024: Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06)’
Compliance with a harmonised standard provides a presumption of conformity with the relevant essential requirements laid down in Union harmonisation legislation. This presumption applies from the date on which the reference to the standard is published in the Official Journal of the European Union.
Accordingly, this Implementing Decision enters into force on the date of its publication.
The implementing decision can be accessed using the following link
