Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products

• CELEX: Implementing Decision (EU) 2021/609
• Articles: 3

Article 1

Annex I to Implementing Decision (EU) 2020/439 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

Annex I is amended as follows:

(1)

entry 5 is replaced by the following:

No

Reference of the standard

‘5.

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)’;

(2)

the following entries 42 and 43 are added:

No

Reference of the standard

‘42.

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)

43.

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)’.