If you are interested in manufacturing face masks or respirators the FDA has put together this new web resource that helps answer your questions and provides next steps for action.
Nelson Labs offers a comprehensive set of tests for surgical face masks and general-use medical masks. These tests are essential to ensuring performance properties are validated to support marketing label claims and to classify these mask types.
For CE marking submissions, additional tests may be required depending on label claims.
Summary of face mask tests for ASTM2100:
- Bacterial or Viral Filtration Efficiency (BFE/VFE)
- Differential Pressure
- The Delta P test is performed to determine the breathability of masks by measuring the differential air pressure on either side of the test article using a manometer, at a constant flow rate of 8 L/min.
- Flammability test
- Particle filtration efficiency: Latex particle challenge
- Synthetic blood fluid penetration resistance for face masks
Additional tests to consider for surgical face masks:
- Biocompatibility ISO 10993
For masks that require NIOSH respirator certification (e.g., N95), please see the Respirator Pre-Submission test page.
Download our Face Mask Testing Requirements to assist you in determining which test is required for your location.
Applicable Standards
- ASTM 2100
- EN 14683
- NIOSH
- ISO 10993
