ASTM F2100 Mask Testing Overview

ASTM F2100 Mask Testing Overview

Disposable Face Mask ASTM Testing

In the USA there a few companies that specialize in testing disposable masks, Nelson Labs, and SGS to name a few.  These companies provide a comprehensive set of tests for surgical face masks and general use of medical disposable masks.  The tests are essential to ensure performance properties are validated to support sales and marketing labels and classify these mask types.  A summary of the disposable face mask test is as follows:

  • BFE Test: Bacterial or Viral Filtration Efficiency - the BFE test is performed on filtration materials and devices that are designed to provide protection against biological aerosols, such as face masks.  A simple overview is a Level 1 Mask must have a BFE of higher than 95%, Level 2 & 3 surgical masks must have a BFE of higher than 98%.
  • Breathability Test: The Breathability test or "Delta P" test is performed to determine and indicate the breathability of disposable masks by measuring the differential air pressure on both sides of the mask using a manometer (which is set at a constant flow rate of 8 L/min.  A level 1 mask must be less than 5.0 mmH2O/cm and the Level 2 & 3 Disposable Masks must be greater than 6.0 mmH2O/cm.  This is often called a Differential Pressure test as when for the EN 14683 standard.
  • Flammability Test: This test is really just as it states, the Flammability test evaluates the flammability of disposable face mask.  This test is required by the ASTM F2100 to ensure that all face masks meet the requirements for Class 1 flammability.  Just on a side note, this test is also required for an FDA 510(k) submission.  The Class 1 test is a burn of less than or equal to 3.5 seconds.
  • PFE Test: PFE stands for Particle Filtration Efficiency with is the Latex particle test on the mask.  The PFE test evaluates the non-viable particle filtration efficiency of the filter media in the mask.  This test is performed on disposable face masks and allows 1 cubic foot per minute (CFM) flow to pass through it.  A simple overview is a Level 1 Mask must have a PFE of higher than 95%, Level 2 & 3 surgical masks must have a PFE of higher than 98%.
  • Synthetic Blood Fluid Test: This test doesn't really sound the best but basically is testing for penetration resistance of the face mask from liquids.  The splash resistance test method challenges medical face masks with a fixed volume of synthetic blood directly at high velocity to the center of the mask.  Level 1 masks pass at 80 mmHg, Level 2 masks pass at 120 mmHg, Level 3 masks pass at 160 mmHg.

You will notice this is a very basic overview of the ASTM testing process that normally takes about 5 - 6 weeks to complete.  Please feel free to reach out to us at any time for a full testing report on any of our masks!  When purchasing a Disposable Mask that is Made in the USA it increases the likelihood that the mask has been fully tested and is certified.  As a little tip, I would always as the company you are purchasing the medical mask from to verify the testing reports for the mask you are getting. 

 


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