Bacterial & Viral Filtration Efficacy (BFE/VFE) Test
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Abstract
The Bacterial Filtration Efficiency (BFE) test is performed on filtration materials, fabrics, covers and devices that are designed to provide protection against biological aerosols, such as face masks, surgical gowns, caps, and air filters. It is a measure of a material's resistance to bacterial penetration. The Bacterial Filtration Efficiency test compares the bacterial control numbers with test article effluent numbers to evaluate the filtration efficiency. Staphylococcus aureus is used as the challenge organism. This test is used for FDA 510(k) submissions for surgical masks.
Viral Filtration Efficiency (VFE) test follows the same procedure as BFE, except the challenge organism used is the bacteriophage phiX174. VFE test evaluates the filtration efficiency by comparing viral control numbers with test substance waste numbers.
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