Commission Implementing Decision (EU) 2024/817 of 6 March 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for sterilisation of health care products and packaging for terminally sterilised medical devices

• CELEX: Implementing Decision (EU) 2024/817
• Articles: 3

Article 1

The Annex to Implementing Decision (EU) 2021/1195 is amended in accordance with the Annex to this Decision.

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

In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added:

No

Reference of the standard

‘11.

EN ISO 11137-2:2015

Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

EN ISO 11137-2:2015/A1:2023

12.

EN ISO 11607-1:2020

Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)

EN ISO 11607-1:2020/A1:2023

13.

EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)

EN ISO 11607-2:2020/A1:2023’.