ASTM F2100 is the US standard that classifies medical face masks into three levels — Level 1, Level 2 and Level 3 — by four measured properties: bacterial filtration efficiency (BFE), particle filtration efficiency (PFE), differential pressure (breathability) and splash resistance. A mask's level is set by the lowest of those results, not the highest.
| Property | Level 1 | Level 2 | Level 3 |
|---|---|---|---|
| BFE (bacterial filtration) | ≥ 95% | ≥ 98% | ≥ 98% |
| PFE (particle filtration) | ≥ 95% | ≥ 98% | ≥ 98% |
| Differential pressure (breathability) | < 4.0 mm H₂O/cm² | < 5.0 mm H₂O/cm² | < 5.0 mm H₂O/cm² |
| Splash resistance (synthetic blood) | 80 mmHg | 120 mmHg | 160 mmHg |
| Flammability | Class 1 | Class 1 | Class 1 |
When to use each level
- Level 1 — routine clinic visits, low-splash procedures, visitors and waiting areas.
- Level 2 — general examinations and procedures with light splash.
- Level 3 — procedures with a risk of blood or body-fluid splash, such as oral surgery and endoscopy.
Frequently asked questions
What is the difference between ASTM Level 1 and Level 3 masks?
Level 3 requires higher BFE/PFE thresholds and a higher splash rating (160 vs 80 mmHg); both must still pass the same breathability ceiling.
Does a higher ASTM level mean a more protective mask?
For splash and filtration, yes; but the level is set by the lowest measured property, so a mask can be Level 2 because of one sub-threshold result.
Is ASTM F2100 the same as EN 14683?
No — they are separate standards with different test methods and thresholds.
Where to go next
- Guides: Learning Hub — compliance, product and industry guides
- Tools: Free sterilization & compliance log tools
- Wholesale: Open a wholesale account
- Related guide: ASTM Mask Levels 1–3: PFE & Fluid Resistance for Clinics