ASTM F2100-11(2018)
(Specification)Standard Specification for Performance of Materials Used in Medical Face Masks
Standard Specification for Performance of Materials Used in Medical Face Masks
ABSTRACT
This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability. This specification does not address all aspects of medical face mask design and performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory protection, which may be necessary for some health care services.
SCOPE
1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used in providing healthcare services such as surgery and patient care.
1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to penetration by synthetic blood, and flammability.
1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This specification does not also apply to respiratory protection, which may be necessary for some healthcare services.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 The following precautionary caveat pertains only to the test methods portion, Section 9, of this specification: 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.
1.6 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.
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Designation:F2100 −11 (Reapproved 2018)
Standard Specification for
Performance of Materials Used in Medical Face Masks
This standard is issued under the fixed designation F2100; 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.
1. Scope 2. Referenced Documents
2.1 ASTM Standards:
1.1 This specification covers testing and requirements for
F1494 Terminology Relating to Protective Clothing
materials used in the construction of medical face masks that
F1862 TestMethodforResistanceofMedicalFaceMasksto
are used in providing healthcare services such as surgery and
Penetration by Synthetic Blood (Horizontal Projection of
patient care.
Fixed Volume at a Known Velocity)
1.2 This specification provides for the classification of
F2101 Test Method for Evaluating the Bacterial Filtration
medical face mask material performance. Medical face mask Efficiency (BFE) of Medical Face Mask Materials, Using
material performance is based on testing for bacterial filtration a Biological Aerosol of Staphylococcus aureus
F2299 Test Method for Determining the Initial Efficiency of
efficiency, differential pressure, sub-micron particulate filtra-
Materials Used in Medical Face Masks to Penetration by
tionefficiency,resistancetopenetrationbysyntheticblood,and
Particulates Using Latex Spheres
flammability.
2.2 ANSI/ASQC Standard:
1.3 This specification does not address all aspects of medi-
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
cal face mask design and performance. This specification does
spection by Attributes
notspecificallyevaluatetheeffectivenessofmedicalfacemask
2.3 ISO Standard:
designs as related to the barrier and breathability properties.
ISO 2859-1 Sampling Plans for Inspection by Attributes
This specification does not also apply to respiratory protection,
2.4 Military Standard:
which may be necessary for some healthcare services.
MIL-M-36954C MilitarySpecification,Mask,Surgical,Dis-
1.4 The values stated in SI units are to be regarded as
posable
standard. No other units of measurement are included in this
2.5 Federal Standards:
standard.
16CFRPart1610 StandardfortheFlammabilityofClothing
1.5 The following precautionary caveat pertains only to the
Textiles
test methods portion, Section 9, of this specification: This
29 CFR Part 1910.1030 Occupational Exposure to Blood-
standard does not purport to address all of the safety concerns,
borne Pathogens: Final Rule
if any, associated with its use. It is the responsibility of the user
42 CFR Part 84 Approval of Respiratory Protective Devices
of this standard to establish appropriate safety, health, and
environmental practices and determine the applicability of 3. Terminology
regulatory limitations prior to use.
3.1 Definitions:
1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the 2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Development of International Standards, Guides and Recom-
Standards volume information, refer to the standard’s Document Summary page on
mendations issued by the World Trade Organization Technical
the ASTM website.
Barriers to Trade (TBT) Committee.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Milwaukee, WI 53203, http://www.asq.org.
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
1 5
This specification is under the jurisdiction of ASTM Committee F23 on Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
Personal Protective Clothing and Equipment and is the direct responsibility of Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://
Subcommittee F23.40 on Biological. dodssp.daps.dla.mil.
Current edition approved Jan. 1, 2018. Published January 2018. Originally AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
approved in 2001. Last previous edition approved in 2011 as F2100 – 11. DOI: 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
10.1520/F2100-11R18. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2100−11 (2018)
3.1.1 bacterial filtration effıciency (BFE), n—the effective- and viscosity representative of blood and some other body
nessofmedicalfacemaskmaterialinpreventingthepassageof fluids, and the color of blood.
aerosolized bacteria, expressed in the percentage of a known
3.1.10.1 Discussion—The synthetic blood in this test
quantity that does not pass the medical face mask material at a method does not simulate all of the characteristics of blood or
given aerosol flow rate.
body fluids, for example, polarity (wetting characteristics),
coagulation, or content of cell matter.
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
creted by the human body.
3.2 Fordefinitionsofotherprotectiveclothing-relatedterms
3.1.2.1 Discussion—In this specification, body fluids in- used in this test method, refer to Terminology F1494.
clude liquids potentially infected with blood-borne pathogens,
including, but not limited to, blood, semen, vaginal secretions, 4. Significance and Use
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
4.1 This specification covers the minimum performance
otic fluid, saliva in dental procedures, any body fluid that is
requirements for materials used in the construction of medical
visibly contaminated with blood, and all body fluids in situa-
face masks.
tions where it is difficult or impossible to differentiate between
4.2 Thisspecificationprovidesclassificationofperformance
body fluids (see 29 CFR Part 1910.1030).
for a range of medical face mask materials. Medical face mask
3.1.3 body fluid simulant, n—a liquid which is used to act as
performance classes are based on the barrier performance
a model for human body fluids.
properties of the medical face mask materials (fluid resistance,
3.1.4 differential pressure, n—the measured pressure drop
bacterial filtration efficiency, and sub-micron filtration effi-
across a medical face mask material. ciency). The list of specified properties represents industry
3.1.4.1 Discussion—In this specification, differential pres- practices for characterizing material performance, but does not
include all aspects of performance that may be necessary to
sure is expressed as a pressure per unit area.
protect healthcare workers. Therefore, this specification does
3.1.5 flammability, n—those characteristics of a material
not cover medical face masks for all possible use situations.
that pertain to its relative ease of ignition and relative ability to
For example, the Center for Disease Control and Prevention
sustain combustion.
(CDC) specifically requires NIOSH respirators that are at least
3.1.6 medical face mask, n—an item of protective clothing
95 % efficient for tuberculosis exposure control.
designed to protect portions of the wearer’s face, including the
NOTE 1—This specification does not provide specific criteria for
mucous membrane areas of the wearer’s nose and mouth, from
demonstrating medical face mask protection of the patient.
contact with blood and other body fluids during medical
NOTE 2—The level of protection provided by medical face masks
procedures.
depends on several factors not considered in this specification. Examples
include facial fit and material degradation from wearer challenges
3.1.6.1 Discussion—Examples of medical face masks in-
(perspiration, talking, sneezing, and the length of time the medical face
clude surgical masks, procedure masks, isolation masks, laser
mask is worn).
masks, dental masks, and patient care masks.
4.3 Users of this specification are cautioned that improved
3.1.7 penetration,
...
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: F2100 − 11 F2100 − 11 (Reapproved 2018)
Standard Specification for
Performance of Materials Used in Medical Face Masks
This standard is issued under the fixed designation F2100; 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.
1. Scope
1.1 This specification covers testing and requirements for materials used in the construction of medical face masks that are used
in providing health care healthcare services such as surgery and patient care.
1.2 This specification provides for the classification of medical face mask material performance. Medical face mask material
performance is based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency,
resistance to penetration by synthetic blood, and flammability.
1.3 This specification does not address all aspects of medical face mask design and performance. This specification does not
specifically evaluate the effectiveness of medical face mask designs as related to the barrier and breathability properties. This
specification does not also apply to respiratory protection, which may be necessary for some health care healthcare services.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 The following precautionary caveat pertains only to the test methods portion, Section 9, of this specification: 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 safety, health, and healthenvironmental practices and determine the applicability of
regulatory limitations prior to use.
1.6 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
2.1 ASTM Standards:
F1494 Terminology Relating to Protective Clothing
F1862 Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed
Volume at a Known Velocity)
F2101 Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological
Aerosol of Staphylococcus aureus
F2299 Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by
Particulates Using Latex Spheres
2.2 ANSI/ASQC Standard:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes
2.3 ISO Standard:
ISO 2859-1 Sampling Plans for Inspection by Attributes
2.4 Military Standard:
MIL-M-36954C Military Specification, Mask, Surgical, Disposable
This specification 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 April 1, 2011Jan. 1, 2018. Published April 2011January 2018. Originally approved in 2001. Last previous edition approved in 20072011 as
F2100 – 07.F2100 – 11. DOI: 10.1520/F2100-11.10.1520/F2100-11R18.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Available from Standardization Documents Order Desk, DODSSP, Bldg. 4, Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://dodssp.daps.dla.mil.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2100 − 11 (2018)
2.5 Federal Standards:
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
29 CFR Part 1910.1030 Occupational Exposure to Blood-borne Pathogens: Final Rule
42 CFR Part 84 Approval of Respiratory Protective Devices
3. Terminology
3.1 Definitions:
3.1.1 bacterial filtration effıciency (BFE), n—the effectiveness of medical face mask material in preventing the passage of
aerosolized bacteria;bacteria, expressed in the percentage of a known quantity that does not pass the medical face mask material
at a given aerosol flow rate.
3.1.2 body fluid, n—any liquid produced, secreted, or excreted by the human body.
3.1.2.1 Discussion—
In this specification, body fluids include liquids potentially infected with blood-borne pathogens, including, but not limited to,
blood, semen, vaginal secretions, cerebrospinal fluid, synovial fluid and peritoneal fluid, amniotic fluid, saliva in dental procedures,
and any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to
differentiate between body fluids (see 29 CFR Part 1910.1030).
3.1.3 body fluid simulant, n—a liquid which is used to act as a model for human body fluids.
3.1.4 differential pressure, n—the measured pressure drop across a medical face mask material.
3.1.4.1 Discussion—
In this specification, differential pressure is expressed as a pressure per unit area.
3.1.5 flammability, n—those characteristics of a material that pertain to its relative ease of ignition and relative ability to sustain
combustion.
3.1.6 medical face mask, n—an item of protective clothing designed to protect portions of the wearer’s face, including the
mucous membrane areas of the wearer’s nose and mouth, from contact with blood and other body fluids during medical procedures.
3.1.6.1 Discussion—
Examples of medical face masks include surgical masks, procedure masks, isolation masks, laser masks, dental masks, and patient
care masks.
3.1.7 penetration, n—in a protective clothing material or item, the flow of a chemical on a non-molecular level through closures,
porous materials, seams and pinholes, or other imperfections in protective clothing.
3.1.7.1 Discussion—
In this specification, blood or body fluids replace the term chemical and the specific penetration liquid is synthetic blood, a body
fluid simulant.
3.1.8 protective clothing, n—an item of clothing that is specifically designed and constructed for the intended purpose of
isolating all or part of the body from a potential hazard; or, isolating the external environment from contamination by the wearer
of the clothing.
3.1.8.1 Discussion—
The primary purpose of protective clothing is to act as a barrier for the wearer to a hazard. However, the product may also offer
protection as a barrier which prevents the body from being a source of contamination.
3.1.9 sub-micron particulate filtration effıciency, n—the efficiency of the filter material in capturing aerosolized particles smaller
than one micron; expressed as the percentage of a known number of particles that does not pass the medical face mask material
at a given flow rate.
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
F2100 − 11 (2018)
3.1.10 synthetic blood, n—a mixture of a red dye/surfactant, thickening agent, and distilled water having a surface tension and
viscosity representative of blood and some other body fluids, and the color of blood.
3.1.10.1 Discussion—
The synthetic blood in this test method does not simulate all of the characteristics of blood or body fluids, for example, polarity
(wetting characteristics), coagulation, or content of cell matter.
3.2 For definitions of other protective clothing-related terms used in this test met
...
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