If you are interested in manufacturing face masks or respirators the FDA has put together this 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.
Download our Face Mask Testing Requirements to assist you in determining which test is required for your location.
Summary of tests for ASTM F2100:
- Bacterial Filtration Efficiency (BFE)
- Differential Pressure (Delta P to determine breathability)
- Flammability test
- Particle filtration efficiency: Sodium Particle Filtration Efficiency
- Synthetic blood fluid penetration resistance for face masks
- Biocompatibility ISO 10993 (Cytotoxicity, Irritation, Sensitization)
Summary of tests for EN 14683:
- Bacterial Filtration Efficiency (BFE)
- Differential Pressure (Delta P to determine breathability)
- Microbial Cleanliness
- Synthetic blood fluid penetration resistance for face masks
- Biocompatibility ISO 10993 (Cytotoxicity, Irritation, Sensitization)
Summary of tests for NIOSH:
- For masks that require NIOSH respirator certification (e.g., N95), please see the Respirator Pre-Submission test page.
Applicable Standards
- ASTM F2100
- EN 14683
- NIOSH
- ISO 10993
