COMMISSION IMPLEMENTING DECISION (EU) 2021/1195
of 19 July 2021
on the harmonised standards for
in vitro
diagnostic medical devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council
Article 1
Article 2
ANNEX
No |
Reference of the standard |
1. |
EN ISO 11135:2014 Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) EN ISO 11135:2014/A1:2019 |
2. |
EN ISO 11137-1:2015 Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) EN ISO 11137-1:2015/A2:2019 |
3. |
EN ISO 11737-2:2020 Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) |
4. |
EN ISO 25424:2019 Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |