GBPI offers a comprehensive set of testing machine for surgical face masks and general-use medical masks. These tests are essential to ensuring performance properties are validated to support marketing label claims and to classify these mask types. For CE marking submissions, additional tests may be required depending on label claims. Summary of face mask testers 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 click to see GBPI face mask testers 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%. Click to see the Principle of BFE tester 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 more details of Particle filtration efficiency tester 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 more details of mask Resistance against Penetration tester Flammability Test: The Flammability test proc...
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