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.
- EN 13795
- EN 14126
- ISO 22612
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|HPT220||Resistance to Dry Microbial Penetration||Add|
HPT220 - Resistance to Dry Microbial Penetration
TAT: 10 days
HPT220: 12 finished products, or 12 samples of ~200 mm x ~200 mm cut from finished products. 1 set (10 replicates; 2 negatives)
Study OutlineDry microbial penetration determines the ability of contaminated particles to migrate through materials. Test specimens are fixed in a container and then talc contaminated with ≥108 colony forming units per gram (CFU/g) of B. atrophaeus is poured onto the test specimen. A sedimentation plate is inserted at the base of each container at a short distance below the test specimen. The apparatus supporting the containers is vibrated at approximately 20,800 rpm for 30 minutes. The talc that penetrates the test material is captured on the sedimentation plate which is removed after testing and incubated.
|Unit||Standard Performance||High Performance|
|Critical Area||Less Critical Area||Critical Area||Less Critical Area|
|CFU||Not required||≤ 300||Not required||≤ 300|