Article 1
The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.
Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices
Commission Implementing Decision (EU) 2023/1410 of 4 July 2023 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for sterilization of health care products and biological evaluation of medical devices
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Article 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX The Annex is amended as follows: (1) entry No 5 is replaced by the following: No Reference of the standard ‘5. EN ISO 25424:2019 Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018) EN ISO 25424:2019/A1:2022’; (2) the following entry is added: No Reference of the standard ‘17. EN ISO 10993-10:2023 Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021)’.
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