The American Society for Testing and Materials (ASTM) is an organization that publishes production and testing standards for a variety of differing industries. Many of the Food and Drug Administration (FDA) requirements for bringing a medical device to market rely on these standards for testing and evaluation, referred to as recognized consensus standards. ASTM F2100, which was most recently revised in 2023, contains performance standards for the materials used in medical face masks [1]. These types of standards documents contain information for a variety of styles/types of face masks and the testing requirements to meet higher classification standards (Level 1 barrier, Level 2 barrier, or Level 3 barrier).
The standard testing methods of ASTM F2100 include bacterial filtration efficiency (BFE), breathing resistance / differential pressure, sub-micron particulate filtration, resistance to penetration by synthetic blood, and flammability [1]. Specifically, capture of sub-micron particles and resistance to penetration by synthetic blood are tested at three varying velocities (minimum, middle velocity, maximum velocity) for the classification of the level of barrier the mask falls under (Level 1 barrier, Level 2 barrier, or Level 3 barrier). However, these two test procedures are defined in ASTM F3502 [2] and ASTM F1862 [3], respectively. Each of these methods are independently defined by other ASTM/ISO/CFR requirements and testing procedures. Proper application of this standard is crucial for FDA compliance and being able to properly market your medical face mask.
If you need help understanding the regulatory testing requirements for any type of medical device that you want to get on the market while maintaining FDA compliance, the team of experts at EMMA International can help! Contact us today at info@emmainternational.com or by calling 248-987-4497.
[1] ASTM. (2023, March 09). Standard Specification for Performance of Materials Used in Medical Face Masks. American Society for Testing and Materials. https://www.astm.org/f2100-23.html
[2] ASTM. (2022, July 20). Standard Specification for Barrier Face Coverings. American Society for Testing and Materials. https://www.astm.org/f3502-21.html [3] ASTM. (2017, June 28). Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity). American Society for Testing and Materials. https://www.astm.org/f1862_f1862m-17.html
