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Sterility Method Suitability Test (B/F)

The Sterility Method Suitability Test (B/F) is necessary to demonstrate that there are no substances produced by the test materials (in the specified volume of test medium) that would cause inhibition of bacterial or fungal growth in a sterility test (i.e., a false negative interpretation).

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Sample device or material in the sterility test medium is tested for growth inhibition using the current USP organisms for Soybean-Casein Digest Medium (SCDM) and Fluid Thioglycollate Medium (FTM). (Additional organisms available upon request.)
Medical device in the sterility test medium is tested for growth inhibition via AAMI standard using Soybean-Casein Digest Medium (SCDM).