ASTM F2101-01

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

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 does 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 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-Apr-2001
• ICS: 11.140 - Hospital equipment
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Replaced By: ASTM F2101-07 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of <i>Staphylococcus aureus</i>
• Effective Date: 01-Feb-2007
• Referred By: ASTM F2302-22 - Standard Performance Specification for Labeling Protective Clothing Which Provides Resistance to Incidental Exposures to Heat or Open Flame
• Effective Date: 10-Apr-2001
• Referred By: ASTM F1494-23 - Standard Terminology Relating to Protective Clothing
• Effective Date: 10-Apr-2001
• Referred By: ASTM F2100-23 - Standard Specification for Performance of Materials Used in Medical Face Masks
• Effective Date: 10-Apr-2001
• Referred By: ASTM F1862/F1862M-17 - Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
• Effective Date: 10-Apr-2001
• Referred By: ASTM F3502-23a - Standard Specification for Barrier Face Coverings
• Effective Date: 10-Apr-2001

Standards Content (Sample)

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:F2101–01
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 F 2101; 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 (e) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
Workers, primarily those in the health care 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 can not eliminate all possible exposures,
attention is placed on reducing the potential of airborne exposure through the use of medical face
masks.
1. Scope system shall be used independently of the other. Combining
values from the two systems may result in nonconformance of
1.1 This test method is used to measure the bacterial
the standard.
filtration efficiency (BFE) of medical face mask materials,
1.6 This test method does not address breathability of the
employing a ratio of the upstream bacterial challenge to
medical face mask materials or any other properties affecting
downstream residual concentration to determine filtration effi-
the ease of breathing through the medical face mask material.
ciency of medical face mask materials.
1.7 This standard does not purport to address all of the
1.2 This test method is a quantitative method that allows
safety concerns, if any, associated with its use. It is the
filtration efficiency for medical face mask materials to be
responsibility of the user of this standard to establish appro-
determined. The maximum filtration efficiency that can be
priate safety and health practices and determine the applica-
determined by this method is 99.9 %.
bility of regulatory limitations prior to use.
1.3 This test method does not apply to all forms or condi-
tions of biological aerosol exposure. Users of the test method
2. Referenced Documents
should review modes for worker exposure and assess the
2
2.1 ASTM Standards:
appropriateness of the method for their specific applications.
E 171 Specification for Standard Atmospheres for Condi-
1.4 This test method evaluates medical face mask materials
tioning and Testing Flexible Barrier Materials
as an item of protective clothing but does not evaluate
F 1494 Terminology Relating to Protective Clothing
materials for regulatory approval as respirators. If respiratory
3
2.2 ANSI/ASQC Standard:
protection for the wearer is needed, a NIOSH-certified respi-
ANSI/ASQC Z1.4 Sampling Procedures and Tables for
rator should be used. Relatively high bacterial filtration effi-
Inspection by Attributes
ciency measurements for a particular medical face mask
4
2.3 ISO Standard:
material does not ensure that the wearer will be protected from
ISO 2859-1 Sampling Plans for Inspection by Attributes
biological aerosols since this test method primarily evaluates
5
2.4 Military Standard:
the performance of the composite materials used in the
construction of the medical face mask and not its design, fit or
facial sealing properties.
2
1.5 Units—The values stated in SI units or inch-pound units
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
are to be regarded separately as standard. The values stated in
Standards volume information, refer to the standard’s Document Summary page on
each system may not be exact equivalents; therefore, each
the ASTM website.
3
AvailablefromAmericanSocietyforQualityControl,611EastWisconsinAve.,
Milwaukee, WI 53202.
1 4
This test method is under the jurisdiction of ASTM Committee F23 on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Protective Clothing and is the direct responsibility of Subcommittee F23.40 on 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Biological. AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
Current edition approved April 10, 2001. Published June 2001. Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
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F2101–01
MIL-STD 36954C (1973) Military Specification: Mask, filtrationefficiency.Therefore,whenusingthistestmethoditis
Surgical, Disposable necessarytodescribethespecificconditionunderwhichtesting
is conducted.
3. Terminology 5.2 T
...