Answers · Medical personal protective equipment and infection barrier

Does ASTM Level 2 medical face mask certification require 98 percent bacterial and sub-micron particulate filtration?

Reviewed by GSE Medical SuppliesLast verified Oct 9, 20264 sources

Short answer

Yes, ASTM Level 2 medical face mask certification requires at least 98 percent bacterial filtration efficiency and 98 percent sub-micron particulate filtration efficiency at 0.1 microns under the ASTM F2100 standard. These certified masks also resist fluid penetration at a pressure of 120 mm Hg. Healthcare workers and caregivers should select Level 2 masks for procedures involving moderate fluid splash risk and airborne particle exposure.

Yes, under the ASTM F2100 standard, Level 2 medical face mask certification requires a minimum of 98 percent Bacterial Filtration Efficiency and 98 percent Sub-Micron Particulate Filtration Efficiency at 0.1 microns.

Healthcare workers and family caregivers face varying levels of fluid exposure and airborne particles during medical procedures and wound care. The ASTM International standard established the ASTM F2100 specification to categorize medical masks into three distinct protection levels based on standardized laboratory testing.

If you only do one thing: Choose an ASTM Level 2 mask whenever clinical tasks involve moderate fluid splash risk alongside aerosol exposure, ensuring 120 mm Hg fluid resistance and 98 percent filtration.

  • Bacterial filtration efficiency (BFE): Requires at least 98 percent filtration against biological aerosols containing *Staphylococcus aureus* bacteria at an average particle size of 3.0 microns (one-thousandth of a millimeter).
  • Sub-micron particulate filtration (PFE): Demands a minimum 98 percent capture rate for polystyrene latex spheres measuring 0.1 microns under ASTM F2299 testing, filtering out fine aerosolized particles.
  • Fluid resistance: Withstands synthetic blood penetration at a pressure of 120 mm Hg (millimeters of mercury) under ASTM F1862, protecting against moderate splashes during wound irrigation or minor procedures.
  • Differential pressure (Delta P): Must maintain a breathability score below 6.0 mm H2O/cm² (millimeters of water pressure per square centimeter), which measures air resistance across the material layers to keep breathing comfortable.
  • Flame spread rating: Requires a Class 1 flammability rating under 16 CFR Part 1610, confirming the fabric does not ignite rapidly when exposed to electrical sparks or surgical heat sources.
  • Watch out for: Confusing loose-fitting ASTM Level 2 procedural masks with NIOSH-approved N95 respirators, which form a tight facial seal and are required for airborne isolation protocols.
  • Watch out for: Using Level 2 masks during high-fluid, arterial-bleed surgical cases, where ASTM Level 3 masks rated to 160 mm Hg fluid resistance are necessary.
  • Watch out for: Non-medical consumer masks labeled with vague terms like "high filtration" that lack verified ASTM F2100 certification data on the packaging.

Review the specification label on your mask box to verify compliance with ASTM F2100 Level 2 standards before performing procedures with moderate fluid exposure. Consult your facility infection control officer or a qualified occupational health professional for task-specific personal protective equipment requirements.

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