Recommended test methods and pass/fail criteria for a respirator fit capability test of half-mask air-purifying respirators

• Published in: Journal of occupational and environmental hygiene Vol. 14; no. 6; pp. 473 - 481
• Main Authors: Zhuang, Ziqing, Bergman, Michael, Lei, Zhipeng, Niezgoda, George, Shaffer, Ronald
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 01.06.2017
• Subjects: Equipment Design; Fit test; Humans; Masks - standards; Materials Testing - methods; N95 respirator; National Institute for Occupational Safety and Health, U.S; NIOSH-certified respirator; Occupational Exposure - prevention & control; respirator fit capability; Respiratory Protective Devices - standards; United States; United States; NIOSH-certified respirator; Fit test; respirator fit capability; N95 respirator
• ISSN: 1545-9624; 1545-9632
• DOI: 10.1080/15459624.2017.1296233

This study assessed key test parameters and pass/fail criteria options for developing a respirator fit capability (RFC) test for half-mask air-purifying particulate respirators. Using a 25-subject test panel, benchmark RFC data were collected for 101 National Institute for Occupational Safety and Health-certified respirator models. These models were further grouped into 61 one-, two-, or three-size families. Fit testing was done using a PortaCount® Plus with N95-Companion accessory and an Occupational Safety and Health Administration-accepted quantitative fit test protocol. Three repeated tests (donnings) per subject/respirator model combination were performed. The panel passing rate (PPR) (number or percentage of the 25-subject panel achieving acceptable fit) was determined for each model using five different alternative criteria for determining acceptable fit. When the 101 models are evaluated individually (i.e., not grouped by families), the percentages of models capable of fitting >75% (19/25 subjects) of the panel were 29% and 32% for subjects achieving a fit factor ≥100 for at least one of the first two donnings and at least one of three donnings, respectively. When the models are evaluated grouped into families and using >75% of panel subjects achieving a fit factor ≥100 for at least one of two donnings as the PPR pass/fail criterion, 48% of all models can pass. When >50% (13/25 subjects) of panel subjects was the PPR criterion, the percentage of passing models increased to 70%. Testing respirators grouped into families and evaluating the first two donnings for each of two respirator sizes provided the best balance between meeting end user expectations and creating a performance bar for manufacturers. Specifying the test criterion for a subject obtaining acceptable fit as achieving a fit factor ≥100 on at least one out of the two donnings is reasonable because a majority of existing respirator families can achieve an PPR of >50% using this criterion. The different test criteria can be considered by standards development organizations when developing standards.