Alexander Herman1, Daniel Porter1, Dana Rottach1, Suvajyoti Guha1. 1. Center for Devices and Radiological Health, US Food and Drug Administration, 10903 New Hampshire Ave., Building 62, Room 2229, Silver Spring, MD 20993.
Abstract
Background: Non-medical face masks, such as face coverings donned by the general population play an important role in reducing transmission of respiratory pathogens. Pressure drop or breathability of such masks is an important attribute especially with the advent of new standards such as ASTM F3502-21 that have specified pressure drop limits for general use of face coverings. Although several standards are available that discuss pressure drop measurement techniques, the methodologies reported are typically complex or are part of more sophisticated and expensive instruments. Thus, the applicability of such methods is often limited to medical device manufacturers. Objective and Methods: This manuscript adapts from the pressure drop measurements proposed in British Standard EN 14683:2019 and describes a methodology to create a simple 3D printed model of a pressure rig for measuring the breathing resistance across non-medical face masks. The method also enables real time pressure drop data acquisition and analysis of multiple samples or batches using Python and MATLAB scripts. Results: We performed a validation study by comparing the pressure drop obtained for one brand of respirators with our set up and compared it with data obtained by traditional means by CDC. An unpaired two-tailed student t-test (n=3) between the two means implied no statistically significant difference. Conclusion: The method we have developed can be easily implemented at community levels for characterizing the breathability of non-medical grade face masks.
Background: Non-medical face masks, such as face coverings donned by the general population play an important role in reducing transmission of respiratory pathogens. Pressure drop or breathability of such masks is an important attribute especially with the advent of new standards such as ASTM F3502-21 that have specified pressure drop limits for general use of face coverings. Although several standards are available that discuss pressure drop measurement techniques, the methodologies reported are typically complex or are part of more sophisticated and expensive instruments. Thus, the applicability of such methods is often limited to medical device manufacturers. Objective and Methods: This manuscript adapts from the pressure drop measurements proposed in British Standard EN 14683:2019 and describes a methodology to create a simple 3D printed model of a pressure rig for measuring the breathing resistance across non-medical face masks. The method also enables real time pressure drop data acquisition and analysis of multiple samples or batches using Python and MATLAB scripts. Results: We performed a validation study by comparing the pressure drop obtained for one brand of respirators with our set up and compared it with data obtained by traditional means by CDC. An unpaired two-tailed student t-test (n=3) between the two means implied no statistically significant difference. Conclusion: The method we have developed can be easily implemented at community levels for characterizing the breathability of non-medical grade face masks.
Entities:
Keywords:
COVID-19; breathing resistance; face coverings; facemasks; masks; pressure drop
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