On October 17, 2025, the EU Commission published the Commission Implementing Decision (EU) 2025/2078, which amends Implementing Decision (EU) 2021/1182. This new decision confirms the adoption of harmonized standards for several categories of medical devices, specifically surgical clothing and drapes, medical face masks, and sterilizers for medical purposes. The decision outlines the following standards, which have now been officially confirmed:
- EN 13795-1:2025: Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns
- EN 13795-2:2025: Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits
- EN 14683:2025: Medical face masks – Requirements and test methods
- EN 14180:2025: Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing’
The full implementation decision can be accessed using the following link
