Article 1
Open ↗The Annex to Implementing Decision (EU) 2021/1195 is amended in accordance with the Annex to this Decision.
Source
Commission Implementing Decision (EU) 2026/2481 of 9 November 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for sterilization of health care products
Commission Implementing Decision (EU) 2026/2481 of 9 November 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for sterilization of health care products
In force
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 2
Open ↗This Decision shall enter into force on the day of its publication in the Official Journal of the European Union . Point (1) of the Annex shall apply from 10 May 2028.
Supplementary provisions
ANNEXSupplementary provisions
Open ↗ANNEX The Annex to Implementing Decision (EU) 2021/1195 is amended as follows: (1) entry No 2 is deleted; (2) the following entry is inserted between entries 2 and 3: ‘2a. 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)’
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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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