ASTM F3502-22a
(Specification)Standard Specification for Barrier Face Coverings
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.
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 ...
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Designation: F3502 − 22a
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, and reuse potential. The level of source control/protection depends on how well particles are
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 reuse of the barrier face covering, so the possibility of reuse 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
to further evolve this specification for addressing new knowledge about disease transmission reduction
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 a degree of particulate filtration that potentially reduces the
amount of aerosols inhaled by the wearer.
1.1 This specification is intended to help ensure barrier face
coverings meeting the stated requirements provide (1) a means
NOTE 1—The source control/protection provided by barrier face cov-
of source control for individual wearers by reducing expelled erings depends on several factors not considered in this specification, such
as material degradation from wearer challenges including perspiration,
aerosols from the wearer’s nose and mouth into the air; and (2)
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
1
This specification is under the jurisdiction of ASTM Committee F23 on
well as fit, comfort, durability, and consumer appeal. (https://
Personal Protective Clothing and Equipment and is the direct responsibility of
www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-
Subcommittee F23.65 on Respiratory.
cov2.html.)
Current edition approved July 1, 2022. Published July 2022. Originally approved
in 2021. Last previous edition approved in 2022 as F3502 – 22. DOI: 10.1520/ NOTE 2—There are currently no established methods for measuring
F3502-22A. 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
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F3502 − 22a
Nothing in this specification addresses or implies a quantitative assess-
1.3 This specification addresses all ba
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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: F3502 − 22 F3502 − 22a
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, and re-usereuse potential. The level of source control/protection depends on how well
particles are 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-usereuse of the barrier face covering, so the possibility
of re-usereuse 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
to further evolve this specification for addressing new knowledge about disease transmission reduction
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
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 expelled aerosols from the
1
This specification 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 June 1, 2022July 1, 2022. Published July 2022. Originally approved in 2021. Last previous edition approved in 20212022 as
F3502 – 21.F3502 – 22. DOI: 10.1520/F3502-22.10.1520/F3502-22A.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F3502 − 22a
wearer’s nose and mouth into the air; and (2) to potentially offer a degree of particulate filtration to reduce that potentially reduces
the amount of aerosols 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 a
...
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