Medical Supplies Information – ASTM face mask

We will answer you some of the popular questions in the medical supplies industry about the ASTM face mask.

  1. Q: What does ASTM stand for?
    • A: ASTM stands for American Society for Testing and Materials, which was formed in 1898 in the US. They changed their name to ASTM International in 2001. It is an international standards organization that develops and publishes voluntary consensus technical standards for different materials, products, systems, and services.  
      ASTM International does not require the mandatory use of its standards. But many municipal, state and federal governments in the U.S. and around the world, have referenced ASTM standards.

  2. Q: What are the ASTM standards for face masks?
    • ASTM standards are referenced by the Food and Drug Administration (FDA) in the U.S. The up-to-date ASTM F2100-11 (2018) standard states the following  5 requirements for face masks:

      1. Fluid Resistance: It measures the ability of the mask’s material to resist the penetration of blood and body fluids. The face masks are tested on three speeds of synthetic blood sprayed on the mask’s material. The three speeds represent three ranges of human blood pressure (80, 120 and 160 mm Hg). The ASTM standard requires the ASTM F2100-11 Level 1 face masks to pass the 80 mm Hg pressure, while it needs the Level 2 and Level 3 face masks pass 120 and 160 mm Hg respectively. The test is conducted by ASTM F1862 (Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)).

       

      1. Particulate Filtration Efficiency (PFE): PFE test the efficiency of the mask’s material to prevent the penetration of particulates. It is recommended using of 0.1 micron polystyrene latex spheres in the test. The ASTM standard requires a minimum 95% filtration rate to pass the ASTM F2100-11 Level 1 face masks, while it needs the filtration rate of more than 98% for Level 2 and Level 3. The test is conducted by ASTM F2299 (Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres).

       

      1. Bacterial Filtration Efficiency (BFE): BFE evaluate the efficiency of bacterial filtration. It tests the ability of the mask’s material to prevent the passage of aerosolized bacteria. The ASTM standard requires a minimum 95% filtration rate to pass the ASTM F2100-11 Level 1 face masks, while it needs the filtration rate of more than 98% for Level 2 and Level 3. The test is conducted by ASTM F2101 (Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus).

       

      1. Pressure Differential (Delta P): Delta P measures the pressure drop across a surgical facemask material. It represents the resistance of the mask’s material to air flowing through the mask. A drop in pressure correlates to the breathability and comfort of the face mask. That said, a lower Delta P results in a higher breathability. To pass the ASTM F2100-11 Level 1 face masks, it requires the Delta P should be less than 4 mm H20/cm2, while it needs the Delta P should be less than 5 mm H20/cm2 for the Level 2 and Level 3 masks. The test is conducted by MIL-M-36954C Military Specification, Mask, Surgical, Disposable.

       

      1. Flammability Test: It tests the flame resistance of the mask’s material. All levels of ASTM F2100-11 should at least meet the class 1 material standard. The test is conducted by 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles