Negative pressure barrier face coverings (e.g., N95) are devices where the air is purified by being pulled inwards through a filtration media during breathing. By design, the efficacy of these devices relies on the air to pass solely through the incorporated filter. Air leaving through unintended gaps in the respirator’s seal compromise its efficacy and may provide lower-than-desired protection.
In light of the recent pandemic, and the subsequent increase in importance of facial coverings, ensuring a respirators appropriate fit has evolved from a matter of personal safety to a matter of public safety. As a result, the ability of a respirator to fit appropriately on the diverse face shapes and sizes of any given community become paramount to that community’s public health. For this reason, fit testing of air-purifying, negative pressure respirators should be conducted by manufacturers to measure how well the respirator seals with faces of different shapes/sizes and thus provide confidence that their respirator fully protects users regardless of their face shape/size
Our most robust study follows the ASTM F3407 method. It uses twenty-five (25) test subjects to evaluate face mask fit capability on a variety of facial shapes and sizes using a standardized panel composition described by NIOSH. The exercises and pass/fail criteria of the test are identical to those required by OSHA for respirator users in the professional workplace for protection from hazardous gases and particulates.
This clinical evaluation is a streamlined version of the full 25 subject panel, performed with only 10 study subjects. Unlike the 25 subject version, it does not offer a pass/fail criteria evaluation, however it does provide empirical data on the devices fit performance across the full facial shape and size standardized panel composition.
Our Bozeman facility also offers design analysis evaluation to support fit efficacy. Our design analysis service measures key components of the devices design, and evaluates the designs probability of fit on a variety of face shapes and sizes.
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