Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Sets requirements for an aseptically processed device to be labeled sterile.
The text of this standard is sold by CEN and is not reproduced here. This page gives the code, edition, scope and what each market says about it.
Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts
| Market | Status | Edition accepted | National code | Details |
|---|---|---|---|---|
| European Union | Harmonized | EN 556-2:2024 | - | Recognition number MDR entry 30; IVDR entry 17. Effective April 9, 2025. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
| United Kingdom | Recognized | EN 556-2:2024 | - | Recognition number List row 7. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not. |
Open the market page and its pathway pages for the full requirement, protocol and report content
Related standards: ISO 11135, GB 18279-2023, ISO 11137-1, ISO 11137-2, ISO 17665, ISO 11737-1, ISO 11737-2, ISO 10993-7, ISO 25424, ISO 14160. See .
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.