Guidance for transparent medical mask technical specifications: Technical requirements for manufacturers
To claim that the mask is a transparent medical mask, the manufacturer must be able to:
- meet ASTM F2100 level 1, 2 or 3 specifications, or EN 14683 Type IIR or comparable standards for medical mask materials
- provide differential pressure and filtration efficiency measurements for the entire transparent medical mask
- substantiate any additional claims that go beyond the standard testing for medical masks (for example, antimicrobial)
The following table summarizes the ASTM F2100 and EN 14683 requirements for medical masks (source: Buy and Sell website).
| Test | Typical Canada/US ASTM F2100 |
EN 14683 | ||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Type IIR | |
| Bacterial filtration efficiency, % | ≥95 | ≥98 | ≥98 | ≥98 |
| Differential pressure mm H20/cm2 (Pa/cm2) | <5.0 | <6.0 | <6.0 | <5.0 <49.0 |
| Submicron particulate filtration efficiency at 0.1 micron, % | ≥95 | ≥98 | ≥98 | Not required |
| Splash resistance/synthetic blood resistance, mmHG | 80 | 120 | 160 | 120 (16.0kPa) |
| Flame spread | Class 1 | Class 1 | Class 1 | N/A |
| Microbial cleanliness (cfu/g) | N/A | N/A | N/A | <30 |
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