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How to choose the ASTM levels of masks? 2023 - 04 - 07

In the healthcare setting, choosing the appropriate face mask is a key component in minimizing the spread of potentially infectious diseases. However, choosing the correct mask can be a difficult task considering the different options, prices, and brands that are out on the market.

Well then, what criteria should you use when choosing a face mask? The FDA, who oversees the sale and marketing of all surgical masks, recommends that manufacturers demonstrate mask performance in 4 areas:

 

Fluid Resistance

Differential Pressure

Filter Efficiency

Flammability

 

ASTM International has been long-held as one of the largest standards for the testing of face masks in these 4 areas and is recognized by the FDA. According to ASTM Standard F2100-11, there are 3 different levels of protection.

Below is brief guide breaking down the appropriate level mask for the procedure at hand.

Minimum Protection Ideal as a simple barrier for exams and short procedures that do not produce fluid, spray or aerosols.  
Level 1 Ideal for procedures where low amounts of fluid, spray and/or aerosols are produced.  
Level 2 Ideal for procedures where low to moderate amounts of fluid, spray and/or aerosols are produced.  
Level 3 Ideal for procedures where moderate to heavy amounts of fluid, spray and/or aerosols are produced.  

 

And here's a guide that shows the specific data required in order to be labeled a ASTM Performance mask. Below is brief guide breaking down the appropriate level mask for the procedure at hand.

ASTM F2100-11 Standards

ASTM Level 1 Mask

ASTM Level 2 Mask

ASTM Level 3 Mask

Fluid Resistance, mmHg

80

120

160

BFE

≥95%

≥98%

≥98%

PFE, @ 0.1 micron

≥95%

≥98%

≥98%

Delta P, mm H20/cm2

< 4.0

< 5.0

< 5.0

Flame Spread

Class 1

Class 1

Class 1

 

How do you know if your face mask will protect you from infectious microorganisms? Look at the package! The new ASTM F2100-11 standard requires a graphic display on the packaging stating the mask performance level. ASTM International levels of protection are a well-known guide used to select the mask design, fit and filtration that matches the protection needed for each procedure or risk level.

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