ASTM F2101-23

Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of <emph type="ital" >Staphylococcus aureus</emph>

SIGNIFICANCE AND USE
5.1 This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition under which testing is conducted.  
5.2 This test method has been specifically designed for measuring bacterial filtration efficiency of medical face masks, using Staphylococcus aureus as the challenge organism. The use of S. aureus is based on its clinical relevance as a leading cause of nosocomial infections.  
5.3 This test method has been designed to introduce a bacterial aerosol challenge to the test specimens at a flow rate of 28.3 L/mm (1 ft3/min). This flow rate is within the range of normal respiration and within the limitations of the cascade impactor.  
5.4 Unless otherwise specified, the testing shall be performed with the inside of the medical face mask in contact with the bacterial challenge. Testing may be performed with the aerosol challenge directed through either the face side or liner side of the test specimen, thereby allowing evaluation of filtration efficiencies which relate to both patient-generated aerosols and wearer-generated aerosols.  
5.5 Degradation by physical, chemical, and thermal stresses could negatively impact the performance of the medical face mask material. The integrity of the material can also be compromised during use by such effects as flexing and abrasion, or by wetting with contaminants such as alcohol and perspiration. Testing without these stresses could lead to a false sense of security. If these conditions are of concern, evaluate the performance of the medical face mask material for bacterial filtration efficiency following an appropriate pretreatment technique representative of the expected conditions of use. Consider preconditioning to assess the impact of storage conditions and shelf life for disposable products, an...
SCOPE
1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.  
1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %.  
1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications.  
1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material do not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties.  
1.5 Units—The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance of the standard.  
1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material.  
1.7 This test method may also be used to measure the bacterial filtration efficienc...

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

Relations

• Refers: ASTM E171/E171M-11(2020) - Standard Practice for Conditioning and Testing Flexible Barrier Packaging
• Effective Date: 01-May-2020

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: F2101 − 23
Standard Test Method for
Evaluating the Bacterial Filtration Efficiency (BFE) of
Medical Face Mask Materials, Using a Biological Aerosol of
1
Staphylococcus aureus
This standard is issued under the fixed designation F2101; 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
Workers, primarily those in the healthcare profession involved in treating and caring for individuals
injured or sick, as well as the patient, can be exposed to biological aerosols capable of transmitting
disease. These diseases, which may be caused by a variety of microorganisms, can pose significant
risks to life and health. Since engineering controls cannot eliminate all possible exposures, attention
is placed on reducing the potential of airborne exposure through the use of medical face masks.
1. Scope 1.5 Units—The values stated in SI units or inch-pound units
are to be regarded separately as standard. The values stated in
1.1 This test method is used to measure the bacterial
each system may not be exact equivalents; therefore, each
filtration efficiency (BFE) of medical face mask materials,
system shall be used independently of the other. Combining
employing a ratio of the upstream bacterial challenge to
values from the two systems may result in nonconformance of
downstream residual concentration to determine filtration effi-
the standard.
ciency of medical face mask materials.
1.6 This test method does not address breathability of the
1.2 This test method is a quantitative method that allows
medical face mask materials or any other properties affecting
filtration efficiency for medical face mask materials to be
the ease of breathing through the medical face mask material.
determined. The maximum filtration efficiency that can be
determined by this method is 99.9 %. 1.7 This test method may also be used to measure the
bacterial filtration efficiency (BFE) of other porous medical
1.3 This test method does not apply to all forms or condi-
products such as surgical gowns, surgical drapes, and sterile
tions of biological aerosol exposure. Users of the test method
barrier systems.
should review modes for worker exposure and assess the
1.8 This standard does not purport to address all of the
appropriateness of the method for their specific applications.
safety concerns, if any, associated with its use. It is the
1.4 This test method evaluates medical face mask materials
responsibility of the user of this standard to establish appro-
as an item of protective clothing but does not evaluate
priate safety, health, and environmental practices and deter-
materials for regulatory approval as respirators. If respiratory
mine the applicability of regulatory limitations prior to use.
protection for the wearer is needed, a NIOSH-certified respi-
1.9 This international standard was developed in accor-
rator should be used. Relatively high bacterial filtration effi-
dance with internationally recognized principles on standard-
ciency measurements for a particular medical face mask
ization established in the Decision on Principles for the
material do not ensure that the wearer will be protected from
Development of International Standards, Guides and Recom-
biological aerosols, since this test method primarily evaluates
mendations issued by the World Trade Organization Technical
the performance of the composite materials used in the
Barriers to Trade (TBT) Committee.
construction of the medical face mask and not its design, fit, or
facial-sealing properties.
2. Referenced Documents
2
2.1 ASTM Standards:
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
2
F23.40 on Biological. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved March 1, 2023. Published March 2023. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2001. Last previous edition approved in 2022 as F2101 – 22. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2101-23. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2101 − 23
E171/E171M Practice for Conditioning and Testing Flexible 3.2 For definitions of other protectiv
...

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: F2101 − 22 F2101 − 23
Standard Test Method for
Evaluating the Bacterial Filtration Efficiency (BFE) of
Medical Face Mask Materials, Using a Biological Aerosol of
1
Staphylococcus aureus
This standard is issued under the fixed designation F2101; 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
Workers, primarily those in the healthcare profession involved in treating and caring for individuals
injured or sick, as well as the patient, can be exposed to biological aerosols capable of transmitting
disease. These diseases, which may be caused by a variety of microorganisms, can pose significant
risks to life and health. Since engineering controls cannot eliminate all possible exposures, attention
is placed on reducing the potential of airborne exposure through the use of medical face masks.
1. Scope
1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio
of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask
materials.
1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined.
The maximum filtration efficiency that can be determined by this method is 99.9 %.
1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should
review modes for worker exposure and assess the appropriateness of the method for their specific applications.
1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for
regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used.
Relatively high bacterial filtration efficiency measurements for a particular medical face mask material do not ensure that the
wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite
materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties.
1.5 Units—The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each
system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the
two systems may result in nonconformance of the standard.
1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease
of breathing through the medical face mask material.
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
F23.40 on Biological.
Current edition approved Aug. 1, 2022March 1, 2023. Published September 2022March 2023. Originally approved in 2001. Last previous edition approved in 20192022
as F2101 – 19.F2101 – 22. DOI: 10.1520/F2101-22.10.1520/F2101-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2101 − 23
1.7 This test method may also be used to measure the bacterial filtration efficiency (BFE) of other porous medical products such
as surgical gowns, surgical drapes, and sterile barrier systems.
1.8 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.
1.9 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.
2. Referenced Documents
2
2.1 ASTM Standards:
E171/E171M Practice for Conditioning and Testing Flexible Barrier Packaging
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E691 Practice for
...