ASTM F2100 Mask Performance Tests

ASTM F2100 Mask Performance Tests are tests that are required by the FDA and developed by the American Association of Tests and Materials (ASTM) for protection against infection, perhaps one of the most personal equipment options, and face masks.

The current ASTM F2100 standard specifies performance requirements for Medical Facial Masks with five key criteria. These criteria are:

• BFE (bacterial filtration efficiency) measures how well the mask filters bacteria while dealing with a bacterial aerosol. The ASTM test is indicated by a 3.0 micron droplet size containing Staph, and the average size can be 0.6-0.8 micron. At least 95% filtration rate is required to be named as medical or surgical mask. Medium and high protection masks have a bacteria filtration rate of more than 98% to 99%. Some manufacturers use the Modified Greene and Vesley method to determine the BFE rating. This method is not recommended by ASTM for product comparison or evaluation of consistency.
• PFE (particle filtration efficiency) measures how well a mask filters submicron particles in anticipation that viruses will be filtered similarly. Mask efficiency increases as the percentage increases. Although the test can be done using a particle size of 0.1 to 5.0 microns, ASTM F2100-07 specifies that a 0.1 micron particle size will be used. When comparing test results, it is important to pay attention to the size of the test particles used, since using a larger particle size will produce a misleading PFE rating.
• Fluid Resistance reflects the mask's ability to minimize the amount of fluid that can pass from the outer layers to the inner layer as a result of a splash or spray. ASTM refers to the synthetic blood test at 80, 120 or 160 mm Hg pressures to qualify for low, medium or high fluid resistance. These pressures are associated with blood pressure: 80 mm Hg = venous pressure, 120 mm Hg = arterial pressure, and 160 mm Hg are associated with potential high pressures that may occur during surgery involving high pressure irrigation such as trauma or orthopedic procedures.
• Delta P (pressure difference) measures the air flow resistance of the mask and is an objective measure of breathability. A controlled air flow is passed through a mask and the pressure on both sides of the mask is determined. The difference in pressure is measured and divided into the surface area (cm2) of the tested mask segment. The higher the Delta P value, the harder the user breathes. Delta P is measured in mm H2O / cm2. The ASTM standard requires masks to have a Delta P of less than 5,0 because a higher value is considered too "hot" for general medical or surgical use. Masks with a Delta P value less than 4,0 are acceptable, masks with a Delta P value less than 2,0 are considered "cold".
• Flammability: There are potential fire hazards arising from electrosurgical procedures such as oxygen sources used for anesthesia and other gases and lasers or cautery equipment in operating rooms. All products, including face masks used in the operating room, are tested for flame resistance. As part of the ASTM F2100 test, masks should withstand flame exposure (within the specified distance) for three seconds.

Additionally, in addition to the above tests, all face masks should be tested according to an international standard (ISO 10993-5, 10) for skin sensitivity and cytotoxic tests, so that no material can harm the user. The tests are carried out on all materials, including the masking ties, elastic ear loops, anti-fog strips, visor shields, and all tubing materials that can be used to hold the side coats together.

EUROLAB, with its expert team and technological infrastructure, ASTM F2100 Mask Performance Tests can help you.