Understanding ASTM F2100-19/EN14683:2019 STANDARDS
ASTM F2100-19 | EN 14683:2019 Barrier Levels | |||||
Level 1 | Level 2 | Level 3 | ||||
>95 | >98 | >95 | >98 | |||
>95 | >98 | |||||
Pass at 80 | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 120 mmHg | |||
< 5.0 mmH2O/cm2 | < 6.0 mmH2O/cm2 | < 40 Pa/cm2 | < 60 Pa/cm2 | |||
Class 1 (＜3.5 seconds) | ||||||
| <30 cfu/g | ||||||
510K Guidance recommends testing to ISO10993 | Complete an evaluation according to ISO10993 | |||||
BFE (Bacterial Filtration Efficiency) represents the percentage of aerosol particulates filtered at a size of 3 microns.It is the measure of the efficiency of the mask in filtering bacteria passing through it.
PFE (sub-micron Particulate Filtration Efficiency) represents the percentage of submicron particulates filtered at 0.1 micron. PFE is the measure of the efficiency of the mask in filtering particles passing through it. The size of the particles filtered is critical.
mmH2O/cm2. This determines breathing resistance 一 the higher the Delta P, the less the breathability, but the better the filtration.
SOURCE: ASTM Standard specification for performance of materials used in medical face masks 一 F2100-11 Standard.
*As specified in Test Method F 1862.