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ASTM F3502-21

(Specification)

Standard Specification for Barrier Face Coverings

Standard Specification for Barrier Face Coverings

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...

General Information

Status
Historical
Publication Date
14-Feb-2021
ICS
13.340.30 - Respiratory protective devices
Technical Committee
F23 - Personal Protective Clothing and Equipment
Drafting Committee
F23.65 - Respiratory
Current Stage
Ref Project

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ASTM F3502-21 - Standard Specification for Barrier Face CoveringsASTM F3502-21 - Standard Specification for Barrier Face Coverings
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ASTM F3502-21 - Standard Specification for Barrier Face Coverings
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F3502 −21
Standard Specification for
1
Barrier Face Coverings
This standard is issued under the fixed designation F3502; 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.
INTRODUCTION
This is the first ASTM standard to address this type of product. The standard was primarily
established in response to the global COVID-19 pandemic beginning in 2019 to address a product that
is neither a medical face mask per ASTM Specification F2100 for providing source control, nor a
respirator for providing inhalation protection as defined by regulatory requirements specified in the
United States under 42 CFR Part 84.
This specification is intended to establish a national standard baseline for a source control device.
This standard brings value by specifying minimum design, performance, and testing requirements and
allowing comparison of products by end users where current guidelines have been limited. Evolving
literature suggests that barrier face coverings could reduce the potential for disease transmission, as
well as offering a reduction of inhalation particulate matter by the wearer. The focus of this
specification is to identify how the device should perform in terms of source control/protection,
comfort,andre-usepotential.Thelevelofsourcecontrol/protectiondependsonhowwellparticlesare
blocked from going through the barrier face covering and minimizing the amount of leakage that may
occur around the perimeter of the barrier face covering. The specific performance property for
filtration efficiency provides a greater challenge than most other particulate filtration tests, including
BFE, based on the use of smaller particles and more rigorous test conditions. Barrier face coverings
must be comfortable enough for individuals to be willing to wear them for long periods of time.
Requirements for breathing resistance were incorporated into the specification. The final performance
criterion was the potential for re-use of the barrier face covering, so the possibility of re-use was
identified in the specification.
Users of this standard are directed to Section 1 (Scope) and Section 4 (Significance and Use) to
understand the specific areas addressed by this standard and its limitations, along with the reasons for
choice of specific requirements. Users of this standard are further directed to the specific caveats for
this standard that are included in 1.3 – 1.11. The subcommittee responsible for this standard intends
tofurtherevolvethisspecificationforaddressingnewknowledgeaboutdiseasetransmissionreduction
and barrier face covering design, performance, labeling, conformity assessment, and other aspects of
these products’ safety, health, and environmental impact as this information becomes available.
1. Scope offer a degree of particulate filtration to reduce the amount of
inhaled particulate matter by the wearer.
1.1 This specification is primarily intended to help ensure
barrier face coverings meeting the stated requirements provide
NOTE 1—The source control/protection provided by barrier face cov-
eringsdependsonseveralfactorsnotconsideredinthisspecification,such
(1) a means of source control for individual wearers by
as material degradation from wearer challenges including perspiration,
reducingthenumberofexpelleddropletsandaerosolsfromthe
talking, sneezing, and the length of time the barrier face covering is worn.
wearer’s nose and mouth into the air; and (2) to potentially
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
1
well as fit, comfort, durability, and consumer appeal. (https://
This specification is under the jurisdiction of ASTM Committee F23 on
www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-
Personal Protective Clothing and Equipment and is the direct responsibility of
cov2.html.)
Subcommittee F23.65 on Respiratory.
NOTE 2—There are currently no established methods for measuring
Current edition approved Feb. 15, 2021. Published February 2021. DOI:
10.1520/F3502-21. outward leakage from a barrier face covering, medical mask, or respirator.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3502−21
Nothing in this standard addresses or implies a quantitative assessment of
1.3 This specification addresses all barrier face coverings
outward leakage and no claims can be made about the degree to which a
and only b
...

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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.)
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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).  
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Standard Specification for Barrier Face Coverings

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.
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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...

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ASTM
ASTM F3620-22(Practice)
Standard Practice for Respiratory Protection—Respirator Use—Physical Qualifications for Personnel

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.

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