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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

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

Implementing Decision (EU) 2025/681 · Decision · 3 articles

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 ↗

Article 1

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The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.

Article 2

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This Decision shall enter into force on the day of its publication in the Official Journal of the European Union .

Supplementary provisions

ANNEXSupplementary provisions

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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’.

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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