ASTM F2101-07
(Test Method)Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
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.
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.
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Designation: F2101 − 07
StandardTest Method for
Evaluating the Bacterial Filtration Efficiency (BFE) of
Medical Face Mask Materials, Using a Biological Aerosol of
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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.Anumber 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 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
significantriskstolifeandhealth.Sinceengineeringcontrolscannoteliminateallpossibleexposures,
attention is placed on reducing the potential of airborne exposure through the use of medical face
masks.
1. Scope 1.5 Units—ThevaluesstatedinSIunitsorinch-poundunits
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.
1.2 This test method is a quantitative method that allows 1.6 This test method does not address breathability of the
filtration efficiency for medical face mask materials to be medical face mask materials or any other properties affecting
determined. The maximum filtration efficiency that can be
the ease of breathing through the medical face mask material.
determined by this method is 99.9%.
1.7 This standard does not purport to address all of the
1.3 This test method does not apply to all forms or condi-
safety concerns, if any, associated with its use. It is the
tions of biological aerosol exposure. Users of the test method
responsibility of the user of this standard to establish appro-
should review modes for worker exposure and assess the
priate safety and health practices and determine the applica-
appropriateness of the method for their specific applications.
bility of regulatory limitations prior to use.
1.4 This test method evaluates medical face mask materials
2. Referenced Documents
as an item of protective clothing but does not evaluate
materials for regulatory approval as respirators. If respiratory
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2.1 ASTM Standards:
protection for the wearer is needed, a NIOSH-certified respi-
E171Practice for Conditioning and Testing Flexible Barrier
rator should be used. Relatively high bacterial filtration effi-
Packaging
ciency measurements for a particular medical face mask
F1494Terminology Relating to Protective Clothing
materialdoesnotensurethatthewearerwillbeprotectedfrom
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2.2 ANSI/ASQC Standard:
biological aerosols since this test method primarily evaluates
ANSI/ASQC Z1.4Sampling Procedures and Tables for In-
the performance of the composite materials used in the
spection by Attributes
construction of the medical face mask and not its design, fit or
facial sealing properties.
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ThistestmethodisunderthejurisdictionofASTMCommitteeF23onPersonal For referenced ASTM standards, visit the ASTM website, www.astm.org, or
ProtectiveClothingandEquipmentandisthedirectresponsibilityofSubcommittee contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
F23.40 on Biological. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Feb. 1, 2007. Published February 2007. Originally the ASTM website.
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approved in 2001. Last previous edition approved in 2001 as F2101-01. DOI: Available fromAmerican Society for Quality (ASQ), 600 N. PlankintonAve.,
10.1520/F2101-07. Milwaukee, WI 53203, http://www.asq.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2101 − 07
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2.3 ISO Standard: samplesarecollectedwithnotestspecimenclampedinthetest
ISO 2859-1Sampling Plans for Inspection by Attributes apparatus to determine the upstream aerosol counts.
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2.4 Military Standard:
4.2 Theagarplatesfromthecascadeimpactorareincubated
MIL-STD 36954C (1973)Military Specification: Mask,
for 48 h and counted to determine the number of viable
Surgical, Disposable
particles collected. The ratio of the upstream counts to the
downstream counts collected for the test specimen are calcu-
3. Te
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