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Resistance to Dry Microbial Penetration

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.

Applicable Standards

  • EN 13795
  • EN 14126
  • ISO 22612

Test Options

Standard turn around times (TAT) are listed below. Ask an expert for a specific consultation on your product. If you are ready to submit your samples for testing, click here to fill out the Sample Submission Form.

Code Test TAT (days) Request Quote
HPT220 Resistance to Dry Microbial Penetration 10 Add
HPT220 - Resistance to Dry Microbial Penetration
TAT: 10 days

Sample Specifications

HPT220: 12 finished products, or 12 samples of ~200 mm x ~200 mm cut from finished products. 1 set (10 replicates; 2 negatives)

Study Outline

Dry 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
[Based on EN 13795 Guideline]
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