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WORKING DRAFT 9.15.92—Performance Evaluation of DM and DFM Filter Respirators
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7—Evaluation of face-seal leakage results from nine studies of non-powered, air-purifying halfmasks.

  As discussed earlier in this evaluation,[1] the safety and efficacy of an air-purifying respirator is determined by the efficacy of the face seal in combination with the efficacy of the air-purifying element. As part of this evaluation, NIOSH reviewed and evaluated face-seal leakage data from nine studies of non-powered, air-purifying halfmasks. The Institute conducted a statistical analysis of some published and unpublished studies to evaluate the value of 10%-maximum face-seal leakage that is the accepted value for professional practice for non-powered, air-purifying halfmasks.[2][3][4][5] This analysis was performed because non-powered halfmask facepieces are used daily by several million respirator wearers.[6]
  Respirators are a public health exposure control method with the sole purpose of preventing occupationally-related illness and death. As such, it is important to evaluate the failure rates[7] of the control method as it is implemented in representative applications. Other public health research on control methods typically measure and report failure rates (e.g., study of contraceptive failure rates for birth control

  1. ↑ Refer to discussion presented in this evaluation under Introduction to Respirator-Performance Evaluations, APF Determinations, and Use of APFs.
  2. ↑ NIOSH Respirator Decision Logic, DHHS (NIOSH) Publication # 87-108, Cincinnati, OH (May, 1987), Tables 1–3, pp. 2-4, 13–18, and 27–29.
  3. ↑ American National Standards Institute, Inc.: American National Standard Practices for Respiratory Protection, ANSI Z88.2-1980, New York, New York, (1980), Table 5, pp. 21–23.
  4. ↑ Birkner, L. R.: Respiratory Protection: A Manual and Guideline, American Industrial Hygiene Association, Akron, Ohio (1980).
  5. ↑ Birkner, L. R.: Celanese Corporation Respiratory Protection Manual and Guideline, Celanese Corporation, New York, N.Y. (August 1978), Section 61, pp. 3–4.
  6. ↑ National Institute for Occupational Safety and Health: Preliminary Regulatory Impact Analysis: 42 CFR Part 84, Second Notice of Proposed Rulemaking—Revision of Tests and Requirements for Certification of Respiratory Protective Devices, (September 1989).
  7. ↑ In epidemiologic usage, a rate is the frequency of a characteristic or disease expressed per unit of size of the population or group in which it is observed. In this case the characteristic is a failure of the control method.
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