Masks intended to comply with ASTM F3502 “Standard Specification for Barrier Face Coverings” should undergo the sodium chloride aerosol challenge (NaCl) to evaluate filtration efficiency and airflow resistance test to evaluate breathability.
The following is a table of performance requirements according to ASTM F3502:
|Performance Property||Level 1 (Lower Performance)||Level 2 (Higher Performance)|
|Sub-micron particulate filtration efficiency|
|≥ 20%||≥ 50%|
|Air flow resistance, inhalation||≤ 15mm H2O||≤ 5mm H2O|
Note: Products may comply with either level of each test and should be labelled accordingly. This means there may be products which perform at Level 2 for the sub-micron particulate efficiency test, but only Level 1 for the air flow resistance test. Performance should be indicated according to the results of each test.
Bacterial filtration efficiency may also be assessed which may give more information about the performance of a barrier face covering but results from this test are not required to claim compliance with the standard.
Barrier face coverings should be assessed for biocompatibility to ensure the materials contacting the wearer’s skin is non-irritating and nontoxic. Cytotoxicity, Skin Sensitization and Irritation should be evaluated using ISO/ANSI/AAMI 10993.
Flammability should be assessed per 16 CFR Part 1610 if the barrier face covering will be used in areas where there may be thermal hazards such as flame, high heat or electrical applications.
According to the standard, reusable products should be tested new and after the maximum number of laundering or cleaning cycles according to the care instructions.
Note: a leakage assessment is required and the manufacturer can report this through product design analysis self-declaration or they can conduct a quantitative test to supplement the product design declaration.