Full list of newly EU harmonised standards for medical devices

The existing harmonised standards whose references were replaced with amended versions are:

1. EN ISO 10993-23:2021/A1:2025 – Biological evaluation of medical devices – Part 23: Tests for irritation
2. EN ISO 10993-12:2021/A1:2025 – Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
3. EN ISO 15223-1:2021/A1:2025 – Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (updated EC-REP symbol)
4. EN IEC 60601-2-83:2020/A11:2021 + EN IEC 60601-2-83:2020/A1:2025 – Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
5. EN ISO 10993-17:2023/A1:2025 – Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents

Newly added harmonised standards

The Decision also adds the following new entries to the Annex:

1. EN ISO 1135-4:2025 – Transfusion equipment for medical use – Part 4: Transfusion sets for single use, gravity feed
2. EN ISO 1135-5:2025 – Transfusion equipment for medical use – Part 5: Transfusion sets for single use with pressure infusion apparatus
3. EN ISO 10993-1:2025 – Biological evaluation of medical devices – Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
4. EN ISO 10993-5:2009/A11:2025 – Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
5. EN ISO 12870:2025 – Ophthalmic optics – Spectacle frames – Requirements and test methods
6. EN ISO 14607:2025 – Non-active surgical implants – Mammary implants – Specific requirements
7. EN ISO 14889:2025 – Ophthalmic optics – Spectacle lenses – Fundamental requirements for uncut finished lenses
8. EN ISO 15883-1:2025 – Washer-disinfectors – Part 1: General requirements, terms and definitions and tests
9. EN ISO 15883-2:2025 – Washer-disinfectors – Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
10. EN ISO 15883-3:2025 – Washer-disinfectors – Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
11. EN ISO 15883-7:2025 – Washer-disinfectors – Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment
12. EN ISO 22675:2025 – Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods
13. EN ISO 23908:2025 – Sharps injury protection – Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration – Requirements and test methods
14. EN 60601-1:2006/A13:2024 – Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

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