DIN EN 13795 (surgical textiles)
Also known as: EN 13795, Surgical drapes standard, Surgical gown standard
European standard for surgical gowns, drapes and clean-air suits — defines test methods and limits for barrier performance, bio-burden, bursting strength and fluid penetration.
Description
European standard DIN EN 13795 defines product-specific requirements for surgical gowns, surgical drapes and clean-air suits — together with ISO 14971 (risk management) and ISO 11135 / 11137 (sterilisation) it forms the backbone of CE conformity for sterile medical devices in the operating theatre. Since 2019 it is structured as Part 1 (general requirements) and Part 2 (test methods).
Tested and documented characteristics include resistance to liquid penetration (EN ISO 811, hydrostatic head), resistance to microbial penetration – dry (EN ISO 22612), resistance to microbial penetration – wet (EN ISO 22610), bursting strength (wet/dry), cleanliness with regard to microbes (bioburden) and linting. The standard distinguishes two performance levels: Standard Performance and High Performance — the latter for procedures with high infection risk or heavy fluid exposure (major orthopaedic surgery, emergency surgery).
- Two performance levels: standard and high performance
- Zone concept: critical vs. non-critical product areas
- Test methods per EN ISO 22610 (wet microbes) and EN ISO 22612 (dry microbes)
- Applicable to single-use and reusable textiles
Properties
| Structure | Part 1 requirements, Part 2 test methods |
|---|---|
| Performance classes | Standard / High Performance |
| Key test methods | EN ISO 22610 (wet), 22612 (dry), 811 (head) |
| Application | Surgical gowns, drapes, clean-air suits |
Related product categories
Sources & references
2- Beuth Verlag: DIN EN 13795-1 Beuth Verlag / DIN https://www.beuth.de/de/norm/din-en-13795-1/303974116
- CEN: EN 13795 standards.cencenelec.eu https://standards.cencenelec.eu/dyn/www/f?p=CEN:110:0::::FSP_PROJECT:63325&cs=1
