Medical Mask Testing

Performance & Safety

American Society for Testing of Materials (ASTM) is an international organization that develops standardized performance and safety testing methods for both raw materials and finished products.

The ASTM F2100 testing suite is used by the FDA in their evaluation of Medical Grade Facemasks sold in the United States.

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Summary of ASTM F2100 Tests

  • Bacterial Filtration Efficiency

    BFE test is used to determine how well a mask filters out bacteria. The facemasks are exposed to aerosolized bacteria (typically Staphylococcus aureus). Cell counts are collected from the other side of the mask and compared to a control. Filtration should be greater than or equal to 95% for Level 1 and 98% for Levels 2 & 3.

  • Particle Filtration Efficiency

    PFE is used to determine how well a mask filters particles smaller than bacteria (as small as 0.1 micron). Filtration should be greater than or equal to 95% for Level 1 and 98% for Levels 2 & 3.

  • Synthetic Blood Penetration

    This test is used to determine how well a mask repels blood or other bodily fluids from contacting the wearer's mouth and/or nose. The higher the level of mask, the more protection from blood and fluids it offers. Tested in mmHg, this is a measurement of velocity of synthetic blood shot at the mask face.

  • Differential Pressure

    This tests the overall breathability of a mask. The differential pressure measures the change in airflow from the outside of the mask to the inside of the mask. The lower the differential pressure, the more breathable.

  • Flammability

    This is a standardized test to determine if a material meets basic flammability requirements for wearable articles.

  • Biocompatibility

    A series of three tests used to show that a material is not cytotoxic, does not cause irritation, and does not cause sensitization while worn.

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