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U.S.A.: ASTM F2100-19 STANDARD SPECIFICATION FOR PERFORMANCE OF MATERIALS USED IN MEDICAL FACE MASKS
EUROPE: EN 14683:2019 MEDICAL FACE MASKS – REQUIREMENTS AND TEST METHODS
MEDICAL FACE MASK TESTS AND REQUIREMENTS
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
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
<5.0 mmH
2
O/cm
2
<6.0 mmH
2
O/cm
2
<40 Pa/cm
2
<60 Pa/cm
2
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
(Pass = ≥29 passing, Fail = ≤28 passing)
