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 F3502-23a - Standard Specification for Barrier Face Coverings
• Effective Date: 10-Apr-2001
• Referred By: ASTM F1494-23 - Standard Terminology Relating to Protective Clothing
• 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 F2100-23 - Standard Specification for Performance of Materials Used in Medical Face Masks
• 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
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
2.1 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
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
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
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.
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.
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.
Biological. AvailablefromStandardizationDocumentsOrderDesk,Bldg.4SectionD,700
Current edition approved April 10, 2001. Published June 2001. Robbins Ave., Philadelphia, PA 19111-5094, Attn: NPODS.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2101–01
MIL-STD 36954C (1973) Military Specification: Mask, filtrationefficiency.Therefore,whenusingthistestmethoditis
Surgical, Disposable necessarytodescribethespecificconditionunderwhichtesting
is conducted.
3. Terminology 5.2 This test method has been specifically designed for
measuring bacterial filtration efficiency of medical face masks,
3.1 Definitions:
using Staphylococcus aureus as the challenge organism. The
3.1.1 aerosol, n—a suspension of solid or liquid particles in
use of S. aureus is based on its clinical relevance as a leading
a gas.
cause of nosocomial infections.
3.1.2 agar, n—a semi-solid culture medium used to support
5.3 This test method has been designed to introduce a
the growth of bacteria and other micro-organisms.
bacterial aerosol challenge to the test specimens at a flow rate
3.1.3 airborne exposure pathways, n—inhalation routes of
of 28.3 L/mm. (1 ft /min). This flow rate is within the range of
exposure to the medical face mask wearer.
normal respiration and within the limitations of the cascade
3.1.4 bacterial filtration effıciency (BFE), n—the effective-
impactor.
ness of a medical face mask material in preventing the passage
5.4 This test method allows the aerosol challenge to be
ofaerosolizedbacteria;expressedinthepercentageofaknown
directed through either the face side or liner side of the test
quantity that does not pass the medical face mask material at a
specimen, thereby, allowing evaluation of filtration efficiencies
given aerosol flow rate.
which relate to both patient-generated aerosols and wearer-
3.1.5 biological aerosol, n—a suspension of particles con-
generated aerosols.
taining biological agents which have been dispersed in a gas.
5.5 Degradation by physical, chemical, and thermal stresses
3.1.6 blood-borne pathogen, n—an infectious bacterium or
could negatively impact the performance of the medical face
virus, or other disease inducing microbe carried in blood or
mask material. The integrity of the material can also be
other potentially infectious body fluids.
compromised during use by such effects as flexing and
3.1.7 body fluid, n—any liquid produced, secreted, or ex-
abrasion, or by wetting with contaminants such as alcohol and
creted by the human body.
perspiration.Testingwithoutthesestressescouldleadtoafalse
3.1.8 protective clothing, n—a product which is specifically
sense of security. If these conditions are of concern, evaluate
designed and constructed for the intended purpose of isolating
theperformanceofthemedicalfacemaskmaterialforbacterial
parts of the body from a potential hazard.
filtration efficiency following an appropriate pretreatment tech-
3.1.9 medical face mask, n—an item of protective clothing
nique representative of the expected conditions of use. Con-
designed to protect portions of the wearer’s face, including at
siderpreconditioningtoassesstheimpactofstorageconditions
least the mucous membrane areas of the wearer’s nose and
and shelf life for disposable products, and the effects of
mouth, from contact with blood and other body fluids during
laundering and sterilization for reusable products.
medical procedures.
5.6 If this procedure is used for quality control, perform
3.1.9.1 Discussion—Medical face masks also function to
proper statistical design and analysis of larger data sets. This
partly limit the spread of biological contamination from the
type of analysis includes, but is not limited to, the number of
mask wearer (health care provider) to the patient.
individual specimens tested, the average percent bacterial
3.2 For definitions of other protective clothing-related terms
filtration efficiency, and standard deviation. Data reported in
used in this test method, refer to Terminology F 1494.
this way help to establish confidence limits concerning product
performance.Examplesofacceptablesamplingplansarefound
4. Summary of Test Method
in references such as ANSI/ASQC Z1.4 and ISO 2859-1.
4.1 The medical face mask material is clamped between a
six-stage cascade impactor and an aerosol chamber. The
6. Apparatus and Materials
bacterial aerosol is introduced into the aerosol chamber using
6.1 Apparatus:
a nebulizer and a culture suspension of Staphylococcus aureus.
6.1.1 Autoclave, capable of maintaining 121-123°C.
The aerosol is drawn through the medical face mask material
usingavacuumattachedtothecascadeimpactor.Thesix-stage 6.1.2 Incubator, capable of maintaining 37 6 2°C.
6.1.3 Analytical Balance, capable of weighing 0.001 g.
cascadeimpactorusessixagarplatestocollectaerosoldroplets
which penetrate the medical face mask material. Control 6.1.4 Vortex Mixer, capable of mixing the contents of 16
samples are collected with no test specimen clamped in the test mm 3 150 mm test tubes.
apparatus to determine the upstream aerosol counts.
6.1.5 Orbital Shaker, capable of achieving 100-250 rpm.
4.2 The agar plates from the cascade impactor are incubat
...