PPE & Barrier - Related International Standards
The following non-harmonised international standards are related to PPE & Barrier for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| EN 14683:2025 | Medical face masks - Requirements and test methods | active | 11, 14 | Link |
| EN 455-1:2020 | Medical gloves for single use - Part 1: Requirements and testing for freedom from holes | active | 1, 3, 5, 10 | Link |
| EN 455-2:2024 | Medical gloves for single use - Part 2: Requirements and testing for physical properties | active | 1, 3, 5, 10 | Link |
| EN 455-3:2023 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation | active | 1, 3, 5, 10 | Link |
| EN 455-4:2009 | Medical gloves for single use - Part 4: Requirements and testing for shelf life determination | active | 1, 3, 5, 10 | Link |
| EN ISO 22609:2004 | Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) | active | 1, 3, 5, 10 | Link |