ASTM F2101-14
(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 <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, ...
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 test method may also be used to measure the bacterial filtration efficienc...
General Information
Relations
Buy Standard
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 − 14
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.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 test method may also be used to measure the
1.3 This test method does not apply to all forms or condi-
bacterial filtration efficiency (BFE) of other porous medical
tions of biological aerosol exposure. Users of the test method
products such as surgical gowns, surgical drapes, and sterile
should review modes for worker exposure and assess the
barrier systems.
appropriateness of the method for their specific applications.
1.8 This standard does not purport to address all of the
1.4 This test method evaluates medical face mask materials
safety concerns, if any, associated with its use. It is the
as an item of protective clothing but does not evaluate
responsibility of the user of this standard to establish appro-
materials for regulatory approval as respirators. If respiratory
priate safety and health practices and determine the applica-
protection for the wearer is needed, a NIOSH-certified respi-
bility of regulatory limitations prior to use.
rator should be used. Relatively high bacterial filtration effi-
ciency measurements for a particular medical face mask
2. Referenced Documents
materialdoesnotensurethatthewearerwillbeprotectedfrom
biological aerosols since this test method primarily evaluates 2
2.1 ASTM Standards:
the performance of the composite materials used in the
E171Practice for Conditioning and Testing Flexible Barrier
construction of the medical face mask and not its design, fit or
Packaging
facial sealing properties.
F1494Terminology Relating to Protective Clothing
1
ThistestmethodisunderthejurisdictionofASTMCommitteeF23onPersonal
ProtectiveClothingandEquipmentandisthedirectresponsibilityofSubcommittee
2
F23.40 on Biological. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
CurrenteditionapprovedJuly1,2014.PublishedJuly2014.Originallyapproved contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
in 2001. Last previous edition approved in 2007 as F2101-07. DOI: 10.1520/ Standards volume information, refer to the standard’s Document Summary page on
F2101-14. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2101 − 14
3
2.2 ANSI/ASQC Standard: The aerosol is drawn through the medical face mask material
ANSI/ASQC Z1.4Sampling Procedures and Tables for In- usingavacuumattachedtothecascadeimpactor.Thesix-stage
spection by Attributes cascadeimpactorusessixagarplatestocollectaerosoldroplets
4
2.3 ISO Standard: which penetrate the medical face mask material. Control
ISO 2859-1Sampling Plans for Inspection by Attributes samplesarecollectedwithnotestspecimenclampedinthetest
5
2.4 Military Standard: apparatus to determine the upstream aerosol counts.
MIL-STD 36954
...
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 − 07 F2101 − 14
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 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
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 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 and health practices and determine the applicability of regulatory
limitations prior to use.
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 Feb. 1, 2007July 1, 2014. Published February 2007July 2014. Originally approved in 2001. Last previous edition approved in 20012007 as
F2101 - 01.F2101 - 07. DOI: 10.1520/F2101-07.10.1520/F2101-14.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2101 − 14
2. Referenced Documents
2
2.1 ASTM Standards:
E171 Practice for Conditioning and Testing Flexible Barrier Packaging
F1494 Terminology Relating to Protective Clothing
3
2.2 ANSI/ASQC Standard:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes
4
2.3 ISO Standard:
ISO 2859-1 Sampling Plans for Inspection by Attributes
5
2.4 Military Standard:
MIL-STD 36954C (1973) Military Specification: Mask, Surgical, Disposable
3. Terminology
3.1 Definitions:
3.1.1 aerosol, n—a suspension of solid or liquid particles in a gas.
3.1.2 agar, n—
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.