Sterilization - Steam sterilizers - Large sterilizers
Covers large steam sterilizers.
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 285:2015+A1:2021 | - | Recognition number MDR entry 15. Effective May 17, 2022. Devices that conform to the standard are presumed to conform with the requirements of the Regulation that the standard covers. |
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.