Commission Implementing Decision (EU) 2025/681 of 8 April 2025 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, sterilization of medical devices and patient handling equipment used in ambulances

• CELEX: Implementing Decision (EU) 2025/681
• 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

‘27.

EN 455-1:2020+A2:2024

Medical gloves for single use – Part 1: Requirements and testing for freedom of holes

28.

EN 455-2:2024

Medical gloves for single use – Part 2: Requirements and testing for physical properties

29.

EN 556-1:2024

Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" – Part 1: Requirements for terminally sterilized medical devices

30.

EN 556-2:2024

Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" – Part 2: Requirements for aseptically processed medical devices

31.

EN 1865-2:2024

Patient handling equipment used in ambulances – Part 2: Power assisted stretcher

32.

EN 1865-6:2024

Patient handling equipment used in ambulances – Part 6: Powered chairs’.