Table 2. Comparison of the standard requirements for surgical masks in the US and Europe [55].
| Test | The US ASTM F2100-19 | Europe EN 14683:2019 | ||||
|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Type I | Type II | Type IIR | |
| Bacterial filtration efficiency (%) | ≥95 | ≥98 | ≥98 | ≥95 | ≥98 | ≥98 |
| Particulate filtration efficiency (%) | ≥95 | ≥98 | ≥98 | Not required | Not required | Not required |
| Fluid resistance to synthetic blood | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Not required | Not required | Pass at ≥16.0 kPa (>120 mmHg) |
| Differential Pressure | <5.0 mmH2O/cm2 | <6.0 mmH2O/cm2 | <6.0 mmH2O/cm2 | <40 Pa/cm2 | <40 Pa/cm2 | <60 Pa/cm2 |
| Microbial Cleanliness | Not required | ≤30 CFU/g | ||||
| Flammability | Class 1 | Not required | ||||
| Biocompatibility | 510 K Guidance recommends testing to ISO 10993 | Complete an evaluation according to ISO 10993 | ||||
US, United States; CFU, colony-forming unit; ASTM, American Society for Testing and Materials; ISO, international organization for standardization.