Two new standards have been harmonised with the IVDR. Both standards are related to sterilization.
- EN 556-1:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices
- EN 556-2:2024 Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 2: Requirements for aseptically processed medical devices’
The Implementing Decision can be accessed using the following link
