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Commission Implementing Decision (EU) 2025/2078 of 17 October 2025 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for surgical clothing and drapes, medical face masks and sterilizers for medical purposes

Commission Implementing Decision (EU) 2025/2078 of 17 October 2025 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for surgical clothing and drapes, medical face masks and sterilizers for medical purposes

Implementing Decision (EU) 2025/2078 · 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

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 .

Supplementary provisions

ANNEXSupplementary provisions

ANNEX In the Annex to Implementing Decision (EU) 2021/1182, the following entries are added: No Reference of the standard ‘33. EN 13795-1:2025 Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns 34. EN 13795-2:2025 Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits 35. EN 14683:2025 Medical face masks – Requirements and test methods 36. EN 14180:2025 Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’

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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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