Level 2

Level 3

Type I

Type II

Type IIR

Barrier Testing

BFE %ASTM F2101, EN 14683

≥95

≥98

≥98

PFE %ASTM F2299

≥95

≥98

Not required

Synthetic Blood ASTM F1862, ISO22609

Pass at 120 mmHg

Pass at 160 mmHg

Not required

Pass at ≥ 16.0 kPa(>120 mmHg)

Physical Testing

Differential PressureEN 14683

<6.0 mmH₂O/cm²

<40 Pa/cm²

<60 Pa/cm²

Safety Testing

Flammability16 CFR Part 1610

Class 1 (≥ 3.5 seconds)

See European Medical Directive (2007/47/EC, MDD 93/42/EEC)

Microbial CleanlinessISO 11737-1

Not required

≤30 cfu/g

BiocompatibilityISO 10993

510 K Guidance recommends testing to ISO 10993

Complete an evaluation according to ISO 10993

SamplingANSI/ASQC Z1.4ISO 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 (Pass = ≥29 passing, Fail = ≤28 passing)