Article 1
The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.
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
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .
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’.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.