Bacterial Filtration Efficiency (BFE)
Differential Pressure
Particle filtration efficiency
Synthetic blood fluid penetration resistance for face masks
Ethylene Oxide (EO) Residual Testing
Face Mask Respiratory resistance testing
mask elastic band testing
Flammability test

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Applicable Standards
ASTM 2100
EN 14683
NIOSH
ISO 10993

Study Outline

Bacterial Filtration Efficiency (BFE)

The Bacterial Filtration Efficiency test determines the filtration efficiency by comparing the bacterial control counts to test article effluent counts. The test is conducted using Staphylococcus aureus as the challenge organism. After the filtration media is preconditioned, a liquid suspension of S. aureus is aerosolized and delivered to the filtration media at a constant flow rate of 28.3 liters per minute (LPM) or 1 cubic foot per minute (CFM).

The aerosol droplets are drawn through a six-stage Andersen sampler for collection. The number of bacterial aerosol droplets contacting the filter media is determined by conducting challenge controls without filter medium in the test system. Challenge controls are maintained at 1700 – 3000 colony-forming units (CFU) with a mean particle size (MPS) of 3.0 ± 0.3 µm. This allows filtration efficiencies to be reported up to >99.9%.

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Particle Filtration Efficiency (PFE)

The Particle Filtration Efficiency (PFE) test evaluates the nonviable particle retention or filtration efficiency of filter media and other filtration devices at sub-micron levels. This test is performed on face masks and all filter material that allows 1 cubic foot per minute (CFM) flow to pass through it.
Also referred to as Latex Particle Challenge, this test is required for ASTM F2100 and is performed according to the ASTM F2100 and follows the basic principle of ASTM F2299.

Applicable Standards
ASTM F2100
ASTM F2299
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Synthetic Blood Penetration for Liquid Barriers

The Synthetic Blood Penetration – Splash Resistance test is one of two synthetic blood resistance tests to determine a product’s ability to act as a barrier to blood-borne pathogens. The Splash Resistance test method challenges medical face masks with a fixed volume of synthetic blood directed at high velocity at the center of the mask.

This test is required by ASTM F2100 and is tested in compliance with ASTM F1862, ASTM F2100, EN 14683, and ISO 26609.

Applicable Standards
ASTM F1862
ISO 22609
ASTM F2100
EN 14683

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Flammability Test:

The Flammability test procedure evaluates the flammability of medical textiles including face masks, surgical gowns, and drapes. The test method is designed to comply with 16 CFR Part 1610. This test is required by the ASTM F2100 (Standard Specification for Performance of Materials Used in Medical Face Masks) to ensure that all face masks meet the requirements for Class 1 flammability. Testing is also required for 510(k) submissions to the FDA.

The Flammability test determines the time of flame spread for the given material. All fabrics of natural or regenerated cellulose, as well as certain types of finished and unfinished fabrics made from other natural or synthetic fibers, are combustible. Some combustible fabrics are potentially dangerous to the wearer because of the speed and intensity of flame with which these fabrics burn and their ease of ignition.

Applicable Standards
16 CFR Part 1610
ASTM F2100

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