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Nelson Labs Guide To Face Mask Standards

The document compares medical face mask standards and test requirements between the USA and Europe. It outlines barrier effectiveness, physical properties, safety, and sampling requirements for different mask classifications under ASTM F2100-19 and EN 14683:2019 standards.

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363 views1 page

Nelson Labs Guide To Face Mask Standards

The document compares medical face mask standards and test requirements between the USA and Europe. It outlines barrier effectiveness, physical properties, safety, and sampling requirements for different mask classifications under ASTM F2100-19 and EN 14683:2019 standards.

Uploaded by

sjalife1
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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MEDICAL FACE MASK TESTS AND REQUIREMENTS

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

ASTM F2100-19 EN 14683:2019 Barrier Levels

Level 1 Level 2 Level 3 Type I Type II Type IIR

BFE %
≥95 ≥98 ≥95 ≥98
ASTM F2101, EN 14683

Barrier PFE %
≥95 ≥98 Not required
Testing ASTM F2299

Synthetic Blood ASTM Pass at Pass at Pass at Pass at ≥ 16.0


Not required
F1862, ISO22609 80 mmHg 120 mmHg 160 mmHg kPa (>120 mmHg)

Physical Differential Pressure


<5.0 mmH2O/cm2 <6.0 mmH2O/cm2 <40 Pa/cm2 <60 Pa/cm2
Testing EN 14683

Flammability See European Medical Directive


Class 1 (≥ 3.5 seconds)
16 CFR Part 1610 (2007/47/EC, MDD 93/42/EEC)
Safety Microbial Cleanliness
Testing Not required ≤30 cfu/g
ISO 11737-1

Biocompatibility
510 K Guidance recommends testing to ISO 10993 Complete an evaluation according to ISO 10993
ISO 10993

• AQL 4% for BFE, PFE, Delta P • Minimum of 5 masks up to an AQL of 4% for BFE,
Sampling
• 32 masks for Synthetic Blood Delta P and Microbial Cleanliness
ANSI/ASQC Z1.4
ISO 2859-1
(Pass = ≥29 passing, Fail = ≤28 passing) • 32 masks for Synthetic Blood
• 14 masks for Flammability (Pass = ≥29 passing, Fail = ≤28 passing)

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