Commission Implementing Decision (EU) 2025/679 of 8 April 2025 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilization of medical devices
Updated 10 of April 2025
In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added:
The standards have been prepared by CEN as a reply to the Standardisation Request: Implementing Decision C(2021) 2406 for the revision of existing harmonised standards on in vitro diagnostic medical devices and for the drafting of new harmonised standards in support of Regulation (EU) 2017/746.
The harmonised standards have been prepared by the CEN/TC 204 Sterilization of medical devices.
You may find, obtain and download the updated harmonised standards the reference of which has been cited in the official journal for the In Vitro Diagnostics Medical Devices Regulation: https://genorma.com/en/directive/show/2017/746
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
60.60 Standard published
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
60.60 Standard published
