Table 2.
Comparison of ASTM F2100-19 standard specification for performance of materials used in medical face masks (USA) and EN 14683:2019 medical face mask requirements and test methods–(EU).
| ASTM F2100-19 | EN 14683:2019 Barrier levels | ||||||
|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Type I | Type II | Type IIR | ||
| Barrier testing |
BFE (%) ASTM F2101, EN 14683 |
≥95 | ≥98 | ≥95 | ≥98 | ||
| PFE (%) ASTM F2299 |
≥95 | ≥98 | Not required | ||||
| Splash resistance, Synthetic blood ASTM F1862, ISO22609 |
Pass at
80 mmHg |
Pass at
120 mmHg |
Pass at
160 mmHg |
Not required |
Pass at ≥ 16.0
kPa (120 mmHg) |
||
| Physical testing |
Differential pressure EN 14683 |
5 mmH2O/cm2 | 6 mmH2O/cm2 | 40 Pa/cm2 | 60 Pa/cm2 | ||
| Safety testing |
Flammability 16 CFR Part 1610 |
Class 1 (≥3.5 seconds) |
See European Medical Directive
(2007/47/EC, MDD 93/42/EEC) |
||||
| Microbial cleanliness ISO 11737-1 |
Not required | ≤30 cfu/g | |||||
| Biocompatibility ISO 10993 |
510 k Guidance recommends
testing to ISO 10993 |
Complete an evaluation
according to ISO 10993 |
|||||
| Sampling ANSI/ASQC Z1.4 ISO 2859-1 |
▪ AQL 4% for BFE, PFE, delta P ▪ 32 masks for synthetic blood (Pass ≥29 passing, Fail ≤28 passing) ▪ 14 masks for flammability |
▪ Minimum of 5 masks up to an AQL of 4% for BFE, delta P and microbial cleanliness ▪ 32 masks for synthetic blood splash resistance (Pass ≥ 29 passing, Fail ≤ 28 passing) |
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