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ASTM F 2100 & EN 14863 COMBINED STANDARDS

U.S. – ASTM F2100Test Code & Sample AmountTest Description Sample RequirementsUnit Price & Turnaround Time
BFE101CBacterial Filtration Efficiency$171.60 per sample; $858.00 for 5 tests
Sample Amount5 samples for BFE required, AQL 4% sampling plan required for ASTM F2100, minimum 5 samples up to AQL 4% required for EN 14683; each sample must be 4 x 4 inches minimum or full face mask)32 calendar days
FTS101CFlammability Test$819.00 per set
Sample AmountMinimum of 14 replicate samples (14 samples = 1 set)24 calendar days
PFE115CParticle Filtration Efficiency$185.90 per sample
Sample AmountMinimum of 5 (AQL 4% sampling plan required for ASTM F2100, each sample must be 5 x 5 inches (12 x 12 cm) minimum or full face mask; specify particle size when submitting samples (0.1 for ASTM F2100, 0.3, 0.5 or 1.0 micron)42 calendar days
SBP210CSynthetic Blood Penetration for Face Masks$559.00 per set
Sample Amount32 masks are required for each pressure, 1 extra for setup (33 Total); specify pressure when submitting samples (80, 120 or 160 mmHg) (33 samples = 1 test)22 calendar days
Biocompatibility for medical masks under EUA Cytotoxicity test is required Sensitization and Irritation must be addressed via memo *After EUA all three tests are required for 510(K) filing
CTX125Cytotoxicity: MEM elution, L929, titration method, 4 dose levels$500.00 per test + $325.00 GLP Fee
Sample Amount1 complete device 120cm² ***Recommended to also include an additional “predicate” sample.  This is a comparison device as recommended by the FDA for materials that are inherently cytotoxic. (Example: could be another mask already on the market or new/original manufactured mask when conducting a cleaning/disinfection validation.) SURFACE AREA MUST BE INCLUDED ON SSF. The Lab can do the surface area calculation for an additional Fee 14 calendar days
MCM100Microbial Cleanliness for Face Masks$1,450 per set
Sample Amount5 samples required, Test is per mask type or configuration, 5 samples = 1 set60 calendar days (NO STAT)

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