Standard Test Method for Respirator Fit Capability for Negative-Pressure Half-Facepiece Particulate Respirators

SIGNIFICANCE AND USE
5.1 In the U.S., when 42 Code of Federal Regulations Part 84 (42 CFR 84) was promulgated in 1995, the isoamyl acetate tightness test as described in 30 Code of Federal Regulations Part 11 for certain particulate-removing respirators was removed. These particulate-removing respirators were designed as protection against: (1) fumes of various metals having an air contamination level not less than 0.05 mg/m3, and (2) dusts, fumes, and mists having an air contamination level less than 0.05 mg/m3 or radionuclides. The isoamyl acetate test was removed because particulate respirators had to be modified before they could be tested and there were no other available fit tests suitable to the National Institute for Occupational Safety and Health (NIOSH) for approval testing at the time (1).4 There was a concern that the modified respirators may have had different fitting characteristics from the versions marketed. According to NIOSH, removing this requirement also allowed for further research on the effectiveness of certification fit testing methods (1).  
5.2 NIOSH conducted benchmark testing of 101 respirator models on the market during 2008 and 2009, using a similar test to that described herein (2). The results were analyzed to develop key test parameters and pass/fail criteria options for a respirator fit capability test for half-facepiece air-purifying particulate respirators (3). According to NIOSH, approximately 30 % of the models tested did not have good fitting characteristics (2). This was also supported by published research (4, 5). This standard establishes a performance requirement called respirator fit capability to assess respirator face-sealing characteristics.  
5.3 This standard can be used to evaluate all particulate-removing respirators on a population of wearers. A respirator model meeting the fit capability requirement will be capable of fitting the facial sizes and shapes for which it was designed. To achieve this goal, it is necessary for the method ...
SCOPE
1.1 This standard provides detailed instructions for performing a respirator fit capability test to determine the fit of air-purifying, half-facepiece respirators, which will include both filtering facepiece respirators and elastomeric respirators equipped with any type of particulate filter. The purpose is to increase the probability that available respirators fit a general worker population. The standard provides increased assurance to respirator purchasers and users that respirators that meet the requirement of this standard can be expected to effectively fit persons with various lengths and widths of faces, such as long and narrow or short and wide, when fit tested in the workplace as part of a complete respiratory protection program in accordance with 29 CFR 1910.134.  
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 It is the responsibility of the investigator to determine whether good laboratory practices (GLP standards—40 CFR, Part 160 of FIFRA) are required and to follow them when appropriate.  
1.4 This standard does not address specific product performance standards established by regulatory authorities; see 2.2 for details.  
1.5 This standard does not eliminate the need for every wearer to undergo a personal respirator fit test.  
1.6 This standard does not guarantee that every respirator wearer will be able to achieve the required fit factor on a particular manufacturer’s single-size or multi-size respirator model. Respirator wearers must always be given the opportunity to try other models or other manufacturers’ respirators.  
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior t...

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Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3407 − 21
Standard Test Method for
Respirator Fit Capability for Negative-Pressure Half-
1
Facepiece Particulate Respirators
This standard is issued under the fixed designation F3407; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
1.1 Thisstandardprovidesdetailedinstructionsforperform-
1.8 This international standard was developed in accor-
ing a respirator fit capability test to determine the fit of
dance with internationally recognized principles on standard-
air-purifying, half-facepiece respirators, which will include
ization established in the Decision on Principles for the
both filtering facepiece respirators and elastomeric respirators
Development of International Standards, Guides and Recom-
equipped with any type of particulate filter. The purpose is to
mendations issued by the World Trade Organization Technical
increase the probability that available respirators fit a general
Barriers to Trade (TBT) Committee.
worker population. The standard provides increased assurance
to respirator purchasers and users that respirators that meet the
2. Referenced Documents
requirement of this standard can be expected to effectively fit
2
2.1 ASTM Standards:
persons with various lengths and widths of faces, such as long
F3387 Practice for Respiratory Protection
and narrow or short and wide, when fit tested in the workplace
3
as part of a complete respiratory protection program in
2.2 Federal Standards:
accordance with 29 CFR 1910.134.
29 CFR Part 1910.134 Respiratory Protection
30 CFR Part 11 Respiratory Protective Apparatus, Tests for
1.2 The values stated in SI units are to be regarded as
Permissibility, Fees
standard. No other units of measurement are included in this
42 CFR Part 84 Respiratory Protective Devices
standard.
1.3 It is the responsibility of the investigator to determine
3. Terminology
whether good laboratory practices (GLP standards—40 CFR,
3.1 Definitions:
Part 160 of FIFRA) are required and to follow them when
3.1.1 fit test, n—the use of a protocol to qualitatively or
appropriate.
quantitatively evaluate the fit of a particular respirator on an
1.4 This standard does not address specific product perfor-
individual.
mance standards established by regulatory authorities; see 2.2
3.1.2 high-effıciency particulate air (HEPA) filter, n—a filter
for details.
with a minimum particle removal efficiency of no less than
1.5 This standard does not eliminate the need for every
99.97 % for monodisperse particles having an aerodynamic
wearer to undergo a personal respirator fit test.
diameter of 0.3 µm.
1.6 This standard does not guarantee that every respirator
3.1.3 individual exercise RFC result, n—a numeric assess-
wearer will be able to achieve the required fit factor on a
ment of how well a tight-fitting respirator facepiece fits a test
particular manufacturer’s single-size or multi-size respirator
subject during each exercise performed during a subject
model. Respirator wearers must always be given the opportu-
respirator fit capability (RFC) test. It is the ratio of the
nity to try other models or other manufacturers’ respirators.
concentration outside the facepiece (C ) to the concentration
out
inside the facepiece (C ) not adjusted for respiratory tract
1.7 This standard does not purport to address all of the
in
deposition. (C /C ).
safety concerns, if any, associated with its use. It is the
out in
responsibility of the user of this standard to establish appro-
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF23onPersonal contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Protective Clothing and Equipment and is the direct responsibility of Subcommittee Standards volume information, refer to the standard’s Document Summary page on
F23.65 on Respiratory. the ASTM website.
3
Current edition approved Nov. 1, 2021. Published November 2021. Originally Available from U.S. Government Printing Office, Superintendent of
approved in 2020. Last previous edition approved in 2020 as F3407 – 20. DOI: Documents, 732 N. Capitol St., NW, Washington, DC 20401-0001, http://
10.1520/F3407-21. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F3407 − 20 F3407 − 21
Standard Test Method for
Respirator Fit Capability for Negative-Pressure Half-
1
Facepiece Particulate Respirators
This standard is issued under the fixed designation F3407; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This standard provides detailed instructions for performing a respirator fit capability test to determine the fit of air-purifying,
half-facepiece respirators, which will include both filtering facepiece respirators and elastomeric respirators equipped with any type
of particulate filter. The purpose is to increase the probability that available respirators fit a general worker population. The standard
provides increased assurance to respirator purchasers and users that respirators that meet the requirement of this standard can be
expected to effectively fit persons with various lengths and widths of faces, such as long and narrow or short and wide, when fit
tested in the workplace as part of a complete respiratory protection program in accordance with 29 CFR 1910.134.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 It is the responsibility of the investigator to determine whether good laboratory practices (GLP standards—40 CFR, Part 160
of FIFRA) are required and to follow them when appropriate.
1.4 This standard does not address specific product performance standards established by regulatory authorities; see 2.2 for details.
1.5 This standard does not eliminate the need for every wearer to undergo a personal respirator fit test.
1.6 This standard does not guarantee that every respirator wearer will be able to achieve the required fit factor on a particular
manufacturer’s single-size or multi-size respirator model. Respirator wearers must always be given the opportunity to try other
models or other manufacturers’ respirators.
1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of
regulatory limitations prior to use.
1.8 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1
This test method is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.65 on Respiratory.
Current edition approved Oct. 1, 2020Nov. 1, 2021. Published October 2020November 2021. Originally approved in 2020. Last previous edition approved in 2020 as
F3407 – 20. DOI: 10.1520/F3407-20.10.1520/F3407-21.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3407 − 21
2. Referenced Documents
2
2.1 ASTM Standards:
F3387 Practice for Respiratory Protection
3
2.2 Federal Standards:
29 CFR Part 1910.134 Respiratory Protection
30 CFR Part 11 Respiratory Protective Apparatus, Tests for Permissibility, Fees
42 CFR Part 84 Respiratory Protective Devices
3. Terminology
3.1 Definitions:
3.1.1 fit test, n—the use of a protocol to qualitatively or quantitatively evaluate the fit of a particular respirator on an individual.
3.1.2 high-effıciency particulate air (HEPA) filter, n—a filter with a minimum particle removal efficiency of no less than 99.97 %
for monodisperse particles having an aerodynamic diameter of 0.3 μm.
3.1.3 individual exercise RFC result, n—a numeric assessment of how well a tight-fitting respirator facepiece fits a test subject
during each exercise performed during a subject respirator fit capability (RFC) test. It is the ratio of the concentration outside the
facepiece (C ) to the concentration inside the facepiece (C ) not adjusted for respiratory tract deposition. (C /C ).
out in out in
3.1.4 respirator fit capability (FRC)(RFC) test, n—an assessment of a respirator model’s ability to achieve passing face seal
performance on either the complet
...

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