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.
Nelson Laboratories is now offering two new tests: Hydraulic Burst Test and Resistance to Dry Microbial Penetration.
Hydraulic Burst Test
The evaluation of bursting strength in dry and wet state test (ISO 13938) uses a hydraulic method for determining bursting strength and distension in textiles. The test is performed on materials such as gowns, drapes, and clean air suits, and is part of the test suite required by the EN 13795 guidance. This guidance determines performance requirements and performance levels for gowns, drapes, and clean air suits when used as medical devices. Nelson Laboratories can perform all EN 13795 testing.
Resistance to Dry Microbial Penetration
The resistance to dry microbial penetration test (ISO 22612) evaluates resistance characteristics of protective equipment to dry bacteria-carrying particles.Testing is most often performed on equipment such as surgical gowns, drapes, and clean air suits when used as medical devices. This test is part of a test suite required by the EN 13795 guidance, which determines performance requirements and performance levels for gowns, drapes, and clean air suits when used as medical devices. It is also included in the test suite required by EN 14126, for personal protective equipment. Testing in compliance to EN 13795 is part of following the European Union Medical Device Directive 93/42/EEC, and is important when seeking a CE mark for products marketed in Europe. Nelson Laboratories personnel are experts in barrier testing, and we offer a one-stop shop for barrier tests required for marketing gowns and drapes in both the US and Europe.
For more information, contact our Protective Barriers Department: ProtectiveBarriersStudyDirectors@nelsonlabs.com.