Source

Commission Implementing Decision (EU) 2026/2479 of 9 November 2026 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products, clinical investigation of medical devices for human subjects, natural rubber latex male condoms, biological evaluation of medical devices, washer-disinfectors, medical electrical equipment and small-bore connectors for liquids and gases in healthcare applications

Implementing Decision (EU) 2026/2479 · Decision · 3 articles

In forceIn force from 2026-11-09

Version historyWe hold this version only; in force from 2026-11-09.

Data as of 2026-11-11 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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

Article 2

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This Decision shall enter into force on the day of its publication in the Official Journal of the European Union . Points (1) and (3) of the Annex shall apply from 10 May 2028.

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX The Annex to Implementing Decision (EU) 2021/1182 is amended as follows: (1) entry No 3 is deleted; (2) the following entry is inserted between entries 3 and 4: ‘3a. EN ISO 11137-1:2026 Sterilization of health care products – Radiation – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2025)’; (3) entry No 39 is deleted; (4) the following entry is inserted between entries 39 and 40: ‘39a. EN ISO 14155:2026 Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2026)’; (5) the following entries are added: No Reference of the standard ‘66. EN ISO 4074:2026 Natural rubber latex male condoms – Requirements and test methods (ISO 4074:2026) 67. EN ISO 10993-6:2026 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO 10993-6:2026) 68. EN ISO 10993-7:2026 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2026) 69. EN ISO 15883-6:2026 Washer-disinfectors – Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment (ISO 15883-6:2026) 70. EN IEC 60601-2-22:2020 Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment EN IEC 60601-2-22:2020/A11:2026 71. EN IEC 60601-2-57:2026 Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring, cosmetic and aesthetic use EN IEC 60601-2-57:2026/A11:2026 72. EN ISO 80369-1:2026 Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements (ISO 80369-1:2025)’.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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