Commission Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products

• CELEX: Implementing Decision (EU) 2024/815
• Articles: 3

Article 1

The Annex to Implementing Decision (EU) 2021/1182 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) 2021/1182, the following entries are added:

No

Reference of the standard

‘18.

EN 455-3:2023

Medical gloves for single use – Part 3: Requirements and testing for biological evaluation

19.

EN ISO 10993-15:2023

Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)

20.

EN ISO 10993-17:2023

Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

21.

EN ISO 10993-18:2020

Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020)

EN ISO 10993-18:2020/A1:2023

22.

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

23.

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

24.

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

25.

EN ISO 17664-2:2023

Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices (ISO 17664-2:2021)’.