ASTM F2100

The ASTM F2100 test specification outlines the classification of performance for material used in medical face masks. This standard encompasses testing and performance requirements for materials used to construct medical face masks intended for healthcare services such as surgery and patient care.

This standard does not cover all design and performance aspects of medical face masks, nor does it assess their effectiveness in terms of barrier and breathability properties. Additionally, it is not applicable to respiratory protection, which may be required for certain healthcare services.

Medical face mask material performance is assessed based on Bacterial Filtration Efficiency, Differential Pressure, Sub-Micron Particulate Filtration Efficiency, Resistance to Penetration by synthetic blood, and Flammability. However, it’s important to note that the test standard does not address all aspects of medical face mask design and performance, including the effectiveness of mask designs related to the barrier, breathability properties, and respiratory protection, which may be necessary for certain healthcare services.

Medical face mask materials covered under this specification are designated as one or more of the following performance classes based on the barrier performance properties:

• Level 1 Barrier
• Level 2 Barrier
• Level 3 Barrier

Level 1 Evaluated for their ability to capture sub-micron particles, resistance to penetration by synthetic blood at the Minimum velocity, bacterial filtration efficiency, and differential pressure. Generally used for low-risk situations and procedures, such as visiting a doctor’s office or on public transportation. Designed to protect against respiratory and large particle droplets. These masks are crafted with lightweight, breathable materials and have ear loops or ties to secure the mask in place.

Level 2 is evaluated for its ability to capture sub-micron particles and is assessed for resistance to penetration by synthetic blood at the Middle velocity, Bacterial filtration efficiency, and differential pressure. Typically used in moderate-risk situations, such as dental procedures or hospital visits. Made with more substantial and thicker materials than Level 1. It is intended to provide a higher level of protection than Level 1 and should block at least 98% of tiny (0.1 microns) particles.

Level 3 Evaluated for resistance to penetration by synthetic blood at the Maximum velocity, Submicron Particulate filtration, Bacterial filtration efficiency, and differential pressure.

Generally used in high-risk situations like surgery or exposure to any body fluids. These masks are constructed from the thickest and most substantial materials among ASTM face mask levels, designed to offer the highest degree of protection.

They also have excellent breath resistance and may be used in surgeries or procedures that produce a lot of aerosols. The highest level of protection is provided by Level 3 masks, which are required to have a bacterial filtration efficiency (BFE) of ≥ 98% and a differential pressure of ≤ 160 mm Hg. They are designed to block at least 98% of tiny (0.1 micron) particles and have a high filtration efficiency (up to 99%) for larger particles.