ASTM-rated Masks: Definition and Use
ASTM-rated masks are medical masks that are fluid resistant and have a high degree of filtration efficiency. ASTM-rated masks are rated by three levels, higher-level masks have a higher filtration efficiency and fluid resistance.
ASTM level 1 masks are commonly called procedure masks and ASTM level 2 masks surgical masks. They are usually used by medical staff when performing surgery, dental work, or when dealing with patients in general. The masks are used to reduce the risk of disease transmission by blocking the wearer’s nose and mouth from another person’s blood, respiratory droplets and aerosols, and other body fluids.
This article can help you understand what ASTM-rated means and how much protection each level provides.
What does ASTM-rated mean?
ASTM stands for the American Society of Testing and Materials. Now known as ASTM International, it is a 120-year-old global organization based in the U.S. that sets and defines technical standards for a wide range of materials, products, services, and systems. ASTM’s standards are referenced by the FDA and endorsed by the U.S. government.
ASTM F2100-11 is the standard specification for the performance of the material used in medical face mask. If a mask is labeled ASTM-rated, then it has been tested in a laboratory to prove that it fits the technical standards set forth by ASTM International.
The three levels of ASTM-rated mask
The most important thing to consider when it comes to choosing level 1, 2, or 3 is how at-risk you are at being contaminated by the splashes, sprays, and aerosols of other people’s body fluids (such as blood and respiratory emission).
ASTM-rated masks’ ability to resist fluid penetration increase with their rated levels. In the lab, a set volume of synthetic blood is projected at the mask at various velocities to test its fluid resistance.
The minimum fluid velocity each level of mask is resistant to is:
ASTM Level 1: 80 mmHg
ASTM Level 2: 120 mmHg
ASTM Level 3: 160 mmHg
Wearing an ASTM-rated mask already decreases the risk of other people’s fluids getting into your nose and mouth, but a higher-level mask can offer higher fluid resistance.
ASTM-rated mask filtration efficiency
The second important factor to consider when choosing a level is how much filtration efficiency you want.
BFE shows the percentage of bacteria the mask can filter. If the BFE is ≥95%, then it means the mask can filter 95% or more of all bacteria that pass through the mask.
PFE shows the percentage of sub-micron particles (≥0.1 micron) the mask can filter. If the BFE is ≥95%, then it means the mask can filter 95% or more of all sub-micron particles (≥0.1 micron) that pass through the mask.
Here is the filtration efficiency for the three levels of ASTM
ASTM level 1
PFE: ≥95% @ 0.1 micron
ASTM level 2
PFE: ≥98% @ 0.1 micron
ASTM level 3
PFE: ≥98% @ 0.1 micron
ASTM masks are also rated based on flammability and breathability. They need to be relatively non-flammable and easy to breathe in.
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MOCACARE’s ASTM level 1 Procedure Masks are FDA-authorized. Find Our name and product on FDA’s Official website, listed under “Appendix A: Authorized Surgical Masks.”
MOCACARE is an FDA registered medical device company that holds the US Medical Device Sales License. MOCACARE has in stock ASTM level 1 and level 2 masks and they are now on sale!