F23.65 - Respiratory

SCOPE
1.1 This specification is intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing expelled aerosols from the wearer’s nose and mouth into the air; and (2) a degree of particulate filtration that potentially reduces the amount of aerosols inhaled by the wearer.
Note 1: The source control/protection provided by barrier face coverings depends on several factors not considered in this specification, such as material degradation from wearer challenges including perspiration, talking, sneezing, and the length of time the barrier face covering is worn. Further research is needed to expand the evidence base for the protective effect of face coverings and, in particular, to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal. (https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html.)
Note 2: There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. Nothing in this specification addresses or implies a quantitative assessment of outward leakage and no claims can be made about the degree to which a barrier face covering reduces expired human-generated aerosols.  
1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.  
1.2.1 Design criteria include setting minimum areas of face coverage over the wearer’s nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer’s head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering where the general approach is described in the product report. Manufacturers are permitted to conduct quantitative testing as specified in this specification to supplement the design analysis. Accessories, such as braces or other devices that allow the barrier face covering to better conform to the wearer’s face, are addressed as part of this specification if used for the purpose of reducing leakage.  
1.2.2 Performance and testing criteria define minimum barrier face covering filtration efficiency and airflow resistance performance properties. Sub-micron particulate filtration efficiency represents the ability to capture and reduce respirable aerosols that potentially contain viruses and bacteria. Airflow resistance represents the wearer’s ease of breathing or breathability while wearing the barrier face covering. The impact of repeated cleaning or laundering on continued performance is applied for measuring performance properties for those barrier face coverings that are intended for reuse. Manufacturers are permitted to also provide test results for bacterial filtration efficiency (BFE) as supplemental information to the mandatory performance measurement of sub-micron particulate filtration efficiency.
Note 3: The principal performance criteria for barrier face covering determined by testing are sub-micron particle filtration efficiency and airflow resistance. Quantitative leakage assessment testing is optional for information purposes and is not required. This testing is not likely to be representative of outward leakage from the barrier face covering and should not be claimed to represent the amount of source control offered by the face covering. Bacterial filtration efficiency testing is also optional and not required. It is significantly different than sub-micron filtration efficiency, and the results of BFE testing cannot be interchanged or directly compared.  
1.2.3 Labeling requirements specify the minimum content for labels that appear on the barrier face cover...

SIGNIFICANCE AND USE
4.1 The purpose of this practice is to provide information and guidance on the proper selection, use, and maintenance of respirators, which will help safeguard the life and health of respirator wearers. This practice is written for all persons concerned with respiratory protection, but especially for those primarily responsible for establishing and administering an acceptable respirator program. This practice contains requirements recommended for enforcement authorities in establishing regulations or codes for respiratory protection use.  
4.2 Exceptions—Users of this practice shall be aware that regulatory agencies may have requirements that are different from this practice.
SCOPE
1.1 This practice sets forth minimally accepted practices for occupational respirator use; provides information and guidance on the proper selection, use, and maintenance of respirators; and contains requirements for establishing, implementing, and evaluating respirator programs.  
1.2 This practice covers the use of respirators to protect persons against the inhalation of harmful air contaminants and oxygen-deficient atmospheres in the workplace. The following are not covered by this practice:  
1.2.1 Underwater breathing devices,  
1.2.2 Aircraft oxygen systems,  
1.2.3 Supplied-air suits,  
1.2.4 Use of respirators under military combat conditions, and  
1.2.5 Medical inhalators and resuscitators.  
1.3 Units—The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.4 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.  
1.5 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.

SIGNIFICANCE AND USE
4.1 This practice provides information and guidance to PLHCPs to assist them in determining the medical suitability of personnel for respirator use. It identifies the responsibility of management to provide the PLHCP with supplemental information before the PLHCP makes a recommendation concerning an employee’s ability to use a respirator (9.1). Evaluators shall use their clinical judgment in the application of these guidelines and require additional information or evaluation as necessary to permit certification or classification for respirator use.  
4.2 Shall and Should-The provisions of this practice are mandatory in nature when the word “shall” is used and advisory in nature when the word “should” is used.  
4.3 Exceptions-Users of this practice should be aware that regulatory agencies may have requirements that are different from this practice.
SCOPE
1.1 This practice provides information that is useful for the medical evaluation of respirator users.  
1.2 This practice does not deal with medical surveillance or biological exposure monitoring. It is understood that since local circumstances vary, no set of guidelines can cover all situations, and specific programs and procedures should be modified for each individual workplace. Medical evaluation is only one element of a complete respiratory protection program. A complete respiratory protection program is defined in Practice F3387.  
1.3 Units-The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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.  
1.5 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.

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...

SIGNIFICANCE AND USE
4.1 The purpose of this guide is to provide clear and consistent guidance with regard to the respirator fit-testing components of an effective respiratory protection program.  
4.2 The respirator fit test itself is simply one facet of fit testing. An effective program requires much more, including a qualified person to perform the fit test. This guide provides guidance on exactly what knowledge and skills are necessary to perform as a qualified fit test operator.  
4.3 This guide contains information to aid program managers and fit test operators in preparing to perform a proper fit test. This includes guidance regarding potential interference from other personal protective equipment (PPE) with the respirator, detailed information on respirators used for fit testing, selection of respirators before fit testing, and other considerations that shall be met if the fit test is to be effective.  
4.4 A single fit test exercise protocol cannot model all workplace activities encountered by respirator users. Recognizing this, this guide provides flexibility regarding fit test exercise protocols. Exercises may be selected that are more representative of actual workplace activities, including repeated respirator donning.  
4.5 Exceptions—Users of this guide should be aware that regulatory agencies may have requirements that are different from this guide.
SCOPE
1.1 This guide provides guidance on how to conduct fit testing of tight-fitting respirators and appropriate methods to be used. Fit testing is only one element of a complete respiratory protection program. Examples of complete respiratory protection programs are defined in Practice F3387, 29 CFR 1910.134, and so forth.  
1.2 Purpose—This guide provides requirements for conducting respirator fit testing and includes:  
1.2.1 Qualifications for fit test operators,  
1.2.2 Specific fit test methods,  
1.2.3 Interpretation of fit test results,  
1.2.4 Recordkeeping, and  
1.2.5 Methods to validate new fit test methods.  
1.3 Should and Shall—The provisions of this guide are mandatory in nature when the word “shall” is used and advisory in nature when the word “should” is used.  
1.4 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 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.  
1.6 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.

SCOPE
1.1 This specification is intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing expelled aerosols from the wearer’s nose and mouth into the air; and (2) a degree of particulate filtration that potentially reduces the amount of aerosols inhaled by the wearer.
Note 1: The source control/protection provided by barrier face coverings depends on several factors not considered in this specification, such as material degradation from wearer challenges including perspiration, talking, sneezing, and the length of time the barrier face covering is worn. Further research is needed to expand the evidence base for the protective effect of face coverings and, in particular, to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal. (https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html.)
Note 2: There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. Nothing in this specification addresses or implies a quantitative assessment of outward leakage and no claims can be made about the degree to which a barrier face covering reduces expired human-generated aerosols.  
1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.  
1.2.1 Design criteria include setting minimum areas of face coverage over the wearer’s nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer’s head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering where the general approach is described in the product report. Manufacturers are permitted to conduct quantitative testing as specified in this specification to supplement the design analysis. Accessories, such as braces or other devices that allow the barrier face covering to better conform to the wearer’s face, are addressed as part of this specification if used for the purpose of reducing leakage.  
1.2.2 Performance and testing criteria define minimum barrier face covering filtration efficiency and airflow resistance performance properties. Sub-micron particulate filtration efficiency represents the ability to capture and reduce respirable aerosols that potentially contain viruses and bacteria. Airflow resistance represents the wearer’s ease of breathing or breathability while wearing the barrier face covering. The impact of repeated cleaning or laundering on continued performance is applied for measuring performance properties for those barrier face coverings that are intended for reuse. Manufacturers are permitted to also provide test results for bacterial filtration efficiency (BFE) as supplemental information to the mandatory performance measurement of sub-micron particulate filtration efficiency.
Note 3: The principal performance criteria for barrier face covering determined by testing are sub-micron particle filtration efficiency and airflow resistance. Quantitative leakage assessment testing is optional for information purposes and is not required. This testing is not likely to be representative of outward leakage from the barrier face covering and should not be claimed to represent the amount of source control offered by the face covering. Bacterial filtration efficiency testing is also optional and not required. It is significantly different than sub-micron filtration efficiency, and the results of BFE testing cannot be interchanged or directly compared.  
1.2.3 Labeling requirements specify the minimum content for labels that appear on the barrier face cover...

SCOPE
1.1 This specification is intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing expelled aerosols from the wearer’s nose and mouth into the air; and (2) a degree of particulate filtration that potentially reduces the amount of aerosols inhaled by the wearer.
Note 1: The source control/protection provided by barrier face coverings depends on several factors not considered in this specification, such as material degradation from wearer challenges including perspiration, talking, sneezing, and the length of time the barrier face covering is worn. Further research is needed to expand the evidence base for the protective effect of face coverings and, in particular, to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal. (https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html.)
Note 2: There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. Nothing in this specification addresses or implies a quantitative assessment of outward leakage and no claims can be made about the degree to which a barrier face covering reduces expired human-generated aerosols.  
1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.  
1.2.1 Design criteria include setting minimum areas of face coverage over the wearer’s nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer’s head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering. Manufacturers are permitted to conduct quantitative testing as specified in this standard to supplement the design analysis.  
1.2.2 Performance and testing criteria define minimum barrier face covering filtration efficiency and airflow resistance performance properties. Sub-micron particulate filtration efficiency represents the ability to capture and reduce respirable aerosols that potentially contain viruses and bacteria. Airflow resistance represents the wearer’s ease of breathing or breathability while wearing the barrier face covering. The impact of repeated cleaning or laundering on continued performance is applied for measuring performance properties for those barrier face coverings that are intended for reuse. Manufacturers are permitted to also provide test results for bacterial filtration efficiency (BFE) as supplemental information to the mandatory performance measurement of sub-micron particulate filtration efficiency.
Note 3: The principal performance criteria for barrier face covering determined by testing are sub-micron particle filtration efficiency and airflow resistance. Quantitative leakage assessment testing is optional for information purposes and is not required. This testing is not likely to be representative of outward leakage from the barrier face covering and should not be claimed to represent the amount of source control offered by the face covering. Bacterial filtration efficiency testing is also optional and not required. It is significantly different than sub-micron filtration efficiency, and the results of BFE testing cannot be interchanged or directly compared. The scope of this standard does not include accessories to barrier face coverings.  
1.2.3 Labeling requirements specify the minimum content for labels that appear on the barrier face covering, its immediate packaging, and if different, point-of-sale packaging.  
1.2.4 User instructions are required to guide selection and sizing, proper use (positioning and adjustment), and care i...

SCOPE
1.1 This specification is intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing expelled aerosols from the wearer’s nose and mouth into the air; and (2) a degree of particulate filtration that potentially reduces the amount of aerosols inhaled by the wearer.
Note 1: The source control/protection provided by barrier face coverings depends on several factors not considered in this specification, such as material degradation from wearer challenges including perspiration, talking, sneezing, and the length of time the barrier face covering is worn. Further research is needed to expand the evidence base for the protective effect of face coverings and, in particular, to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal. (https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html.)
Note 2: There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. Nothing in this specification addresses or implies a quantitative assessment of outward leakage and no claims can be made about the degree to which a barrier face covering reduces expired human-generated aerosols.  
1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.  
1.2.1 Design criteria include setting minimum areas of face coverage over the wearer’s nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer’s head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering. Manufacturers are permitted to conduct quantitative testing as specified in this standard to supplement the design analysis.  
1.2.2 Performance and testing criteria define minimum barrier face covering filtration efficiency and airflow resistance performance properties. Sub-micron particulate filtration efficiency represents the ability to capture and reduce respirable aerosols that potentially contain viruses and bacteria. Airflow resistance represents the wearer’s ease of breathing or breathability while wearing the barrier face covering. The impact of repeated cleaning or laundering on continued performance is applied for measuring performance properties for those barrier face coverings that are intended for reuse. Manufacturers are permitted to also provide test results for bacterial filtration efficiency (BFE) as supplemental information to the mandatory performance measurement of sub-micron particulate filtration efficiency.
Note 3: The principal performance criteria for barrier face covering determined by testing are sub-micron particle filtration efficiency and airflow resistance. Quantitative leakage assessment testing is optional for information purposes and is not required. This testing is not likely to be representative of outward leakage from the barrier face covering and should not be claimed to represent the amount of source control offered by the face covering. Bacterial filtration efficiency testing is also optional and not required. It is significantly different than sub-micron filtration efficiency, and the results of BFE testing cannot be interchanged or directly compared. The scope of this standard does not include accessories to barrier face coverings.  
1.2.3 Labelling requirements specify the minimum content for labels that appear on the barrier face covering, its immediate packaging, and if different, point-of-sale packaging.  
1.2.4 User instructions are required to guide selection and sizing, proper use (positioning and adjustment), and care ...

SCOPE
1.1 This specification is primarily intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing the number of expelled droplets and aerosols from the wearer’s nose and mouth into the air; and (2) to potentially offer a degree of particulate filtration to reduce the amount of inhaled particulate matter by the wearer.
Note 1: The source control/protection provided by barrier face coverings depends on several factors not considered in this specification, such as material degradation from wearer challenges including perspiration, talking, sneezing, and the length of time the barrier face covering is worn. Further research is needed to expand the evidence base for the protective effect of face coverings and, in particular, to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal. (https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html.)
Note 2: There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. Nothing in this standard addresses or implies a quantitative assessment of outward leakage and no claims can be made about the degree to which a barrier face covering reduces emission of human-generated particles.  
1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.  
1.2.1 Design criteria include setting minimum areas of face coverage over the wearer’s nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer’s head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering. Manufacturers are permitted to conduct quantitative testing as specified in this standard to supplement the design analysis.  
1.2.2 Performance and testing criteria define minimum barrier face covering filtration efficiency and airflow resistance performance properties. Sub-micron particulate filtration efficiency represents the ability to capture and reduce respirable droplets and aerosols that potentially contain viruses and bacteria. Airflow resistance represents the wearer’s ease of breathing or breathability while wearing the barrier face covering. The impact of repeated cleaning or laundering on continued performance is applied for measuring performance properties for those barrier face coverings that are intended to be reusable. Manufacturers are permitted to also provide test results for bacterial filtration efficiency (BFE) as supplemental information to the mandatory performance measurement of sub-micron particulate filtration efficiency.
Note 3: The principal performance criteria for barrier face covering determined by testing are sub-micron particle filtration efficiency and airflow resistance. Quantitative leakage assessment testing is optional for information purposes and is not required. This testing is not likely to be representative of outward leakage from the barrier face covering and should not be claimed to represent the amount of source control offered by the face covering. Bacterial filtration efficiency testing is also optional and not required. It is significantly different than sub-micron filtration efficiency, and the results of BFE testing cannot be interchanged or directly compared. The scope of this standard does not include accessories to barrier face coverings.  
1.2.3 Labelling requirements specify the minimum content for labels that appear on the barrier face covering, its immediate packaging, and if different, point-of-sale packaging.  
1.2.4 User instructions are required to guide s...

SCOPE
1.1 This specification is primarily intended to help ensure barrier face coverings meeting the stated requirements provide (1) a means of source control for individual wearers by reducing the number of expelled droplets and aerosols from the wearer’s nose and mouth into the air; and (2) to potentially offer a degree of particulate filtration to reduce the amount of inhaled particulate matter by the wearer.
Note 1: The source control/protection provided by barrier face coverings depends on several factors not considered in this specification, such as material degradation from wearer challenges including perspiration, talking, sneezing, and the length of time the barrier face covering is worn. Further research is needed to expand the evidence base for the protective effect of face coverings and, in particular, to identify the combinations of materials that maximize both their blocking and filtering effectiveness, as well as fit, comfort, durability, and consumer appeal. (https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html.)
Note 2: There are currently no established methods for measuring outward leakage from a barrier face covering, medical mask, or respirator. Nothing in this standard addresses or implies a quantitative assessment of outward leakage and no claims can be made about the degree to which a barrier face covering reduces emission of human-generated particles.  
1.2 This specification establishes minimum design, performance (testing), labeling, user instruction, reporting and classification, and conformity assessment requirements for barrier face coverings.  
1.2.1 Design criteria include setting minimum areas of face coverage over the wearer’s nose and mouth, prohibiting open vents or valves, requiring a means for retaining the barrier face covering on the wearer’s head, and providing a representation of product sizing. Manufacturers are further required to perform a design analysis for assessing leakage of exhaled air from the barrier face covering. Manufacturers are permitted to conduct quantitative testing as specified in this standard to supplement the design analysis.  
1.2.2 Performance and testing criteria define minimum barrier face covering filtration efficiency and airflow resistance performance properties. Sub-micron particulate filtration efficiency represents the ability to capture and reduce respirable droplets and aerosols that potentially contain viruses and bacteria. Airflow resistance represents the wearer’s ease of breathing or breathability while wearing the barrier face covering. The impact of repeated cleaning or laundering on continued performance is applied for measuring performance properties for those barrier face coverings that are intended to be reusable. Manufacturers are permitted to also provide test results for bacterial filtration efficiency (BFE) as supplemental information to the mandatory performance measurement of sub-micron particulate filtration efficiency.
Note 3: The principal performance criteria for barrier face covering determined by testing are sub-micron particle filtration efficiency and airflow resistance. Quantitative leakage assessment testing is optional for information purposes and is not required. This testing is not likely to be representative of outward leakage from the barrier face covering and should not be claimed to represent the amount of source control offered by the face covering. Bacterial filtration efficiency testing is also optional and not required. It is significantly different than sub-micron filtration efficiency, and the results of BFE testing cannot be interchanged or directly compared. The scope of this standard does not include accessories to barrier face coverings.  
1.2.3 Labelling requirements specify the minimum content for labels that appear on the barrier face covering, its immediate packaging, and if different, point-of-sale packaging.  
1.2.4 User instructions are required to guide s...

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...

SIGNIFICANCE AND USE
4.1 The purpose of this practice is to provide information and guidance on the proper selection, use, and maintenance of respirators, which will help safeguard the life and health of respirator wearers. This practice is written for all persons concerned with respiratory protection, but especially for those primarily responsible for establishing and administering an acceptable respirator program. This practice contains requirements recommended for enforcement authorities in establishing regulations or codes for respiratory protection use.  
4.2 Exceptions—Users of this practice shall be aware that regulatory agencies may have requirements that are different from this practice.
SCOPE
1.1 This practice sets forth minimally accepted practices for occupational respirator use; provides information and guidance on the proper selection, use, and maintenance of respirators; and contains requirements for establishing, implementing, and evaluating respirator programs.  
1.2 This practice covers the use of respirators to protect persons against the inhalation of harmful air contaminants and oxygen-deficient atmospheres in the workplace. The following are not covered by this practice:  
1.2.1 Underwater breathing devices,  
1.2.2 Aircraft oxygen systems,  
1.2.3 Supplied-air suits,  
1.2.4 Use of respirators under military combat conditions, and  
1.2.5 Medical inhalators and resuscitators.  
1.3 Units—The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.  
1.4 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.  
1.5 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.