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Development of an advanced respirator fit-test headform.

ABSTRACT: Improved respirator test headforms are needed to measure the fit of N95 filtering facepiece respirators (FFRs) for protection studies against viable airborne particles. A Static (i.e., non-moving, non-speaking) Advanced Headform (StAH) was developed for evaluating the fit of N95 FFRs. The StAH was developed based on the anthropometric dimensions of a digital headform reported by the National Institute for Occupational Safety and Health (NIOSH) and has a silicone polymer skin with defined local tissue thicknesses. Quantitative fit factor evaluations were performed on seven N95 FFR models of various sizes and designs. Donnings were performed with and without a pre-test leak checking method. For each method, four replicate FFR samples of each of the seven models were tested with two donnings per replicate, resulting in a total of 56 tests per donning method. Each fit factor evaluation was comprised of three 86-sec exercises: "Normal Breathing" (NB, 11.2 liters per min (lpm)), "Deep Breathing" (DB, 20.4 lpm), then NB again. A fit factor for each exercise and an overall test fit factor were obtained. Analysis of variance methods were used to identify statistical differences among fit factors (analyzed as logarithms) for different FFR models, exercises, and testing methods. For each FFR model and for each testing method, the NB and DB fit factor data were not significantly different (P > 0.05). Significant differences were seen in the overall exercise fit factor data for the two donning methods among all FFR models (pooled data) and in the overall exercise fit factor data for the two testing methods within certain models. Utilization of the leak checking method improved the rate of obtaining overall exercise fit factors ?100. The FFR models, which are expected to achieve overall fit factors ? 100 on human subjects, achieved overall exercise fit factors ? 100 on the StAH. Further research is needed to evaluate the correlation of FFRs fitted on the StAH to FFRs fitted on people. [Supplementary materials are available for this article. Go to the publisher's online edition of Journal of Occupational and Environmental Hygiene for the following free supplemental resource: a file providing detailed information on the advanced head form design and fabrication process.].

SUBMITTER: Bergman MS

PROVIDER: S-EPMC4470376 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Development of an advanced respirator fit-test headform.

Bergman Michael S MS Zhuang Ziqing Z Hanson David D Heimbuch Brian K BK McDonald Michael J MJ Palmiero Andrew J AJ Shaffer Ronald E RE Harnish Delbert D Husband Michael M Wander Joseph D JD

Journal of occupational and environmental hygiene 20140101 2

Improved respirator test headforms are needed to measure the fit of N95 filtering facepiece respirators (FFRs) for protection studies against viable airborne particles. A Static (i.e., non-moving, non-speaking) Advanced Headform (StAH) was developed for evaluating the fit of N95 FFRs. The StAH was developed based on the anthropometric dimensions of a digital headform reported by the National Institute for Occupational Safety and Health (NIOSH) and has a silicone polymer skin with defined local t ...[more]

PMID: 24369934

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Project description:An ASTM International subcommittee on Respiratory Protection, F23.65 is currently developing a consensus standard for assessing respirator fit capability (RFC) criteria of half-facepiece air-purifying particulate respirators. The objective of this study was to evaluate if the test methods being developed for half-facepiece respirators can reasonably be applied to nonpowered full-facepiece-air-purifying respirators (FF-APR). Benchmark RFC test data were collected for three families of FF-APRs (a one-size-only family, a two-size family, and a three-size family). All respirators were equipped with P100 class particulate filters. Respirators were outfitted with a sampling probe to collect an in-mask particle concentration sample in the breathing zone of the wearer. Each of the six respirator facepieces was tested on the National Institute for Occupational Safety and Health 25-subject Bivariate Panel. The RFC test assessed face seal leakage using a PortaCount fit test. Subjects followed the corresponding Occupational Safety and Health Administration-accepted fit test protocol. Two donnings per subject/respirator model combination were performed. The panel passing rate (PPR) (number or percentage of subjects in the panel achieving acceptable fit on at least one of two donnings) was determined for each respirator family at specified fit factor passing levels of 500, 1,000, and 2,000. As a reasonable expectation based on a previous analysis of alpha and beta fit test errors for various panel sizes, the selected PPR benchmark for our study was >75%. At the fit factor passing level of 500 obtained on at least one of two donnings, the PPRs for three-, two-, and one-size families were 100, 79, and 88%, respectively. As the fit factor passing criterion increased from 500 to 1,000 or 2,000, PPRs followed a decreasing trend. Each of the three tested families of FF-APRs are capable of fitting ?75% of the intended user population at the 500 fit factor passing level obtained on at least one of two donnings. The methods presented here can be used as a reference for standards development organizations considering developing RFC test requirements.

Project description:A respirator fit test panel (RFTP) with facial size distribution representative of intended users is essential to the evaluation of respirator fit for new models of respirators. In this study an anthropometric survey was conducted among youths representing respirator users in mid-Taiwan to characterize head-and-face dimensions key to RFTPs for application to small-to-medium facial features. The participants were fit-tested for three N95 masks of different facepiece design and the results compared to facial size distribution specified in the RFTPs of bivariate and principal component analysis design developed in this study to realize the influence of facial characteristics to respirator fit in relation to facepiece design. Nineteen dimensions were measured for 206 participants. In fit testing the qualitative fit test (QLFT) procedures prescribed by the U.S. Occupational Safety and Health Administration were adopted. As the results show, the bizygomatic breadth of the male and female participants were 90.1 and 90.8% of their counterparts reported for the U.S. youths (P < 0.001), respectively. Compared to the bivariate distribution, the PCA design better accommodated variation in facial contours among different respirator user groups or populations, with the RFTPs reported in this study and from literature consistently covering over 92% of the participants. Overall, the facial fit of filtering facepieces increased with increasing facial dimensions. The total percentages of the tests wherein the final maneuver being completed was "Moving head up-and-down", "Talking" or "Bending over" in bivariate and PCA RFTPs were 13.3-61.9% and 22.9-52.8%, respectively. The respirators with a three-panel flat fold structured in the facepiece provided greater fit, particularly when the users moved heads. When the facial size distribution in a bivariate RFTP did not sufficiently represent petite facial size, the fit testing was inclined to overestimate the general fit, thus for small-to-medium facial dimensions a distinct RFTP should be considered.

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Development of an advanced respirator fit-test headform.

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Development of an advanced respirator fit-test headform.

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