Commission Implementing Decision (EU) 2023/1411 of 4 July 2023 amending Implementing Decision (EU) 2021/1195 as regards a harmonised standard for sterilization of health care products

• CELEX: Implementing Decision (EU) 2023/1411
• 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, entry No 4 is replaced by the following:

No

Reference of the standard

‘4.

EN ISO 25424:2019

Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018)

EN ISO 25424:2019/A1:2022’.