Commission Implementing Decision (EU) 2026/1231 of 11 June 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for biological evaluation of medical devices, symbols to be used with information to be supplied by the manufacturer, medical electrical equipment, transfusion equipment for medical use, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics and sharps injury protection

Article 1

The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
Points (1), (3), (7) and (9) of the Annex shall apply from 15 December 2027.
Point (5) of the Annex shall apply from 15 June 2031.

ANNEX

ANNEX
The Annex to Implementing Decision (EU) 2021/1182 is amended as follows:
(1)
entry No 1 is deleted;
(2)
the following entry is inserted:
‘1a.
EN ISO 10993-23:2021
Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
EN ISO 10993-23:2021/A1:2025’
(3)
entry No 7 is deleted;
(4)
the following entry is inserted:
‘7a.
EN ISO 10993-12:2021
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993 12:2021)
EN ISO 10993-12:2021/A1:2025’
(5)
entry No 12 is deleted;
(6)
the following entry is inserted:
‘12a.
EN ISO 15223-1:2021
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
EN ISO 15223-1:2021/A1:2025’
(7)
entry No 14 is deleted;
(8)
the following entry is inserted:
‘14a.
EN IEC 60601-2-83:2020
Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
EN IEC 60601-2-83:2020/A11:2021
EN IEC 60601-2-83:2020/A1:2025’
(9)
entry No 20 is deleted;
(10)
the following entry is inserted:
‘20a.
EN ISO 10993-17:2023
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
EN ISO 10993-17:2023/A1:2025’
(11)
the following entries are added:
No
Reference of the standard
‘52.
EN ISO 1135-4:2025
Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2025)
53.
EN ISO 1135-5:2025
Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2025)
54.
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 (ISO 10993-1:2025)
55.
EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
EN ISO 10993-5:2009/A11:2025
56.
EN ISO 12870:2025
Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2024)
57.
EN ISO 14607:2025
Non-active surgical implants - Mammary implants - Specific requirements (ISO 14607:2024)
58.
EN ISO 14889:2025
Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2025)
59.
EN ISO 15883-1:2025
Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)
60.
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 (ISO 15883-2:2024)
61.
EN ISO 15883-3:2025
Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:2024)
62.
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 (ISO 15883-7:2025)
63.
EN ISO 22675:2025
Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2024)
64.
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 (ISO 23908:2024)
65.
EN 60601-1:2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1:2006/A13:2024’

Schedules & Appendices

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