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

• CELEX: Implementing Decision (EU) 2021/1195
• Articles: 3

Article 1

The references of harmonised standards for in vitro diagnostic medical devices drafted in support of Regulation (EU) 2017/746 and listed in the Annex to this Decision are hereby published in the Official Journal of the European Union .

Article 2

This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

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)