The Microbial Cleanliness Test (Bioburden) is performed on finished face masks. This testing is performed to demonstrate that the manufacturing process is in control and is required by EN 14683:2014. We can provide a one-stop shop for all EN 14683 testing needs.
Applicable Standards
- EN 14683
- EN ISO 11737-1
Study Outline
The Microbial Cleanliness test determines the total number of viable microorganisms on the face mask using an extraction method. The total viable aerobic microbial count and fungal enumeration is determined. Based on the weight of the mask, the results are reported as the total bioburden per gram tested for each mask. According to EN 14683, in order to meet the performance requirements of Type I, Type II, and Type IIR, the bioburden of the face mask shall be ≤ 30 cfu/g.
The number of samples required for this test according to the standard, EN 14683, is a minimum of five masks, but can be greater and shall be increased to allow for an AQL of 4%.
