Anresco Laboratories now offers medical device testing services to assess the conformity of personal protective equipment (PPE) to required specifications. Services offered include:
Particulate Filtration Efficiency (PFE)
(ASTM F2100, ASTM F2299)
The PFE test is performed to determine the efficiency of which a given material (e.g. mask, ventilator) is able to filter particulates passed through it. Anresco performs PFE per the ASTM F2299 standard, specified by ASTM F2100.
Submicron sized latex particles are aerosolized, passed through the filtration material at a constant flow rate, and quantified on the other side of the material via a laser particle counter. Since the latex particle size can be modified, the test can simulate a variety of environmental contaminants that the material is intended to filter against.
Bacterial Filtration Efficiency (BFE)
(ASTM F2100, ASTM F 2101, EN 14683)
The BFE test is performed to determine the efficiency of which a given material (e.g. mask, ventilator, gown) is able to filter bacteria passed through it. Anresco performs BFE per the ASTM F2101 standard, specified by both ASTM F2100 and EN 14683.
Staphylococcus Aureus (the proxy bacteria) is aerosolized, passed through the filtration material at a constant flow rate, and then quantified on the other side of the material. This value is then compared to a control count to determine the filtration efficiency of the material (e.g. 95%).
Air Flow Resistance and Differential Pressure
(ASTM F2100-11, EN 14683)
Air flow resistance and differential pressure is performed to determine the breathability of face masks and ventilators. Anresco performs the analysis per the specifications of the ASTM 2100-11 and EN 14683 standards.
A gas exchanger is utilized with the air flow output set by a gas flow meter. The air flow is passed through the mask or ventilator, the pressure is measured on both sides of the mask, and the difference is calculated.
Synthetic Blood Penetration
(ASTM F1862, ASTM F2100, ISO 22609, EN 14683)
The synthetic blood penetration test is performed to determine the suitability of masks and ventilators to act as a barrier against blood and blood-borne pathogens. Anresco performs this test per the specifications of ASTM F1862, ASTM F2100, EN 14683,and ISO 26609.
The mask is held within a chamber with synthetic blood sprayed at the mask at varying velocities meant to simulate human blood pressure. Resistance of the mask to penetration of the synthetic blood is determined visually.
(BS EN 136-1998, EN 149, 16 CFR Part 1610)
The flammability test evaluates the flammability of face masks, ventilators, and other medical textiles. Anresco utilizes a test method specified by 13 CFR Part 1610 and in compliance with the ASTM F2100 standard.
In response to COVID-19, the Food & Drug Administration (FDA) released the following guidance document lifting regulatory requirements for certain masks and respirators to increase their availability. Read more at the following link.
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency