The European standard, EN 13795, addresses the barrier properties, cleanliness, and strength of surgical drapes, gowns, and clean air suits used to protect patients from secondary infections in the surgical suite. The standard was approved in 2011, updated in 2013, and is the current standard today.
Nelson Laboratories is proud to announce that we are able to perform the eight tests required to meet the EN 13795standard. The addition of Hydraulic Burst Test and Resistance to Dry Microbial Penetration Test in 2016 completed the suite of tests offered by Nelson Laboratories to help manufacturers meet the requirements of the European standard. The following tests have been certified by ANAB to meet the requirements of ISO/IEC 17025:2005:
- HPT220 Resistance to Dry Microbial Penetration
- HPT210 Resistance to Wet Bacterial Penetration
- BIO220 Bioburden
- PSA120 Particle Shed Analysis
- HPT110 Hydrostatic Pressure
- HPT230 Hydraulic Burst Test
- PHY150 Tensile Test, Dry
- PHY155 Tensile Testing
Manufacturers of surgical drapes, gowns, and clean air suits who will be marketing their products in Europe need to make sure their product offerings meet the requirements outlined by EN 13795. Additionally, meeting the requirements of this standard is important for manufacturers who are looking to obtain the CE label for their products.
For more information, contact Nelson Laboratories’ Protective Barriers department ProtectiveBarriersStudyDirectors@NelsonLabs.com.