ASTM F2100-23

Standard Specification for Performance of Materials Used in Medical Face Masks

ABSTRACT
This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. This specification does not address all aspects of medical face mask design and performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory protection, which may be necessary for some health care services.
SCOPE
1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care.  
1.1.1 This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks).  
1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.  
1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to their overall barrier and breathability properties.  
1.3.1 This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face.  
1.4 This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards.
Note 1: Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 The following precautionary caveat pertains only to the test methods portion, Section 9, of this specification: 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.  
1.7 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.

General Information

• Status: Published
• Publication Date: 28-Feb-2023
• ICS: 11.140 - Hospital equipment
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

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: F2100 − 23
Standard Specification for
1
Performance of Materials Used in Medical Face Masks
This standard is issued under the fixed designation F2100; 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 1.5 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1.1 This specification covers testing and requirements for
standard.
materials used in the construction of medical face masks that
1.6 The following precautionary caveat pertains only to the
are used in providing healthcare services such as surgery and
test methods portion, Section 9, of this specification: This
patient care.
standard does not purport to address all of the safety concerns,
1.1.1 This specification addresses medical masks with ties
if any, associated with its use. It is the responsibility of the user
(surgical masks) and ear loops (procedure masks or isolation
of this standard to establish appropriate safety, health, and
masks).
environmental practices and determine the applicability of
1.2 This specification provides for the classification of regulatory limitations prior to use.
medical face mask material performance. Medical face mask 1.7 This international standard was developed in accor-
material performance is based on testing for bacterial filtration dance with internationally recognized principles on standard-
efficiency, differential pressure, sub-micron particulate filtra- ization established in the Decision on Principles for the
tion efficiency, resistance to penetration by synthetic blood, and Development of International Standards, Guides and Recom-
flammability. mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.3 This specification does not address all aspects of medi-
cal face mask design and performance. This specification does
2. Referenced Documents
not specifically evaluate the effectiveness of medical face mask
2
2.1 ASTM Standards:
designs as related to their overall barrier and breathability
F1494 Terminology Relating to Protective Clothing
properties.
F1862 Test Method for Resistance of Medical Face Masks to
1.3.1 This specification does not include any specific design
Penetration by Synthetic Blood (Horizontal Projection of
criteria for medical face masks; however, surgical masks are
Fixed Volume at a Known Velocity)
differentiated by having ties to allow adjustment of the medical
F2101 Test Method for Evaluating the Bacterial Filtration
face mask fit in comparison to procedure or isolation masks,
Efficiency (BFE) of Medical Face Mask Materials, Using
which use ear loops to affix the mask to the wearer’s face.
a Biological Aerosol of Staphylococcus aureus
1.4 This specification does not address requirements for F3050 Guide for Conformity Assessment of Personal Pro-
regulated respiratory protection devices such as respirators,
tective Clothing and Equipment
which may be necessary for some healthcare services and F3502 Specification for Barrier Face Coverings
3
exposure to inhalation hazards.
2.2 ANSI/ASQC Standard:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
NOTE 1—Performance requirements for NIOSH-approved N95 respira-
spection by Attributes
tors are described in 42 CFR Part 84. Additional requirements for
4
NIOSH-approved N95 respirators intended for use in healthcare settings
2.3 ISO Standards:
are described in the Memorandum of Understanding between FDA and
ISO 2859-1 Sampling Plans for Inspection by Attributes
NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH
ISO 10993-1 Biological Evaluation of Medical Devices—
Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010,
November 2018.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
1
This specification is under the jurisdiction of ASTM Committee F23 on Standards volume information, refer to the standard’s Document Summary page on
Personal Protective Clothing and Equipment and is the direct responsibility of the ASTM website.
3
Subcommittee F23.40 on Biological. Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Current edition approved March 1, 2023. Published March 2023. Originally Milwaukee, WI 53203, http://www.asq.org.
4
approved in 2001. Last previous edition approved in 2021 as F2100 – 21. DOI: Available from American National Standar
...

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: F2100 − 21 F2100 − 23
Standard Specification for
1
Performance of Materials Used in Medical Face Masks
This standard is issued under the fixed designation F2100; 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 specification covers testing and requirements for materials used in the construction of medical face masks that are used
in providing healthcare services such as surgery and patient care.
1.1.1 This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks).
1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material
performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency,
resistance to penetration by synthetic blood, and flammability.
1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not
specifically evaluate the effectiveness of medical face mask designs as related to their overall barrier and breathability properties.
1.3.1 This specification does not include any specific design criteria for medical face masks; however, surgical masks are
differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which
use ear loops to affix the mask to the wearer’s face.
1.4 This specification does not address requirements for regulated respiratory protection devices such as respirators, which may
be necessary for some healthcare services and exposure to inhalation hazards.
NOTE 1—Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved
N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU
225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 The following precautionary caveat pertains only to the test methods portion, Section 9, of this specification: 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.
1.7 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 specification is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.40 on Biological.
Current edition approved Aug. 1, 2021March 1, 2023. Published August 2021March 2023. Originally approved in 2001. Last previous edition approved in 20202021 as
F2100 – 20.F2100 – 21. DOI: 10.1520/F2100-21.10.1520/F2100-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2100 − 23
2. Referenced Documents
2
2.1 ASTM Standards:
F1494 Terminology Relating to Protective Clothing
F1862 Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed
Volume at a Known Velocity)
F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological
Aerosol of Staphylococcus aureus
F2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by
Particulates Using Latex Spheres
F3050 Guide for Conformity Assessment of Personal Protective Clothing and Equipment
F3502 Specification for Barrier Face Coverings
3
2.2 ANSI/ASQC Standard:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes
4
2.3 ISO S
...