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
1
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
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.
3
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
4
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,
5
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
6
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.
3
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Milwaukee, WI 53203, http://www.asq.org.
4
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.
6
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
1
---------------------- Page: 1 ----------------------
F2100−11 (2018)
3.1.1 bacterial filtration effıciency (BFE), n—the effective- and viscosity representative of blood and some other body
nessofmedicalfacemaskmaterialinpreventingthepassageof fluids, a
...
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
1
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
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
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-M-36954C Military Specification, Mask, Surgical, Disposable
1
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.
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 Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American Society for Quality (ASQ), 600 N. Plankinton Ave., Milwaukee, WI 53203, http://www.asq.org.
4
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
5
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
1
---------------------- Page: 1 ----------------------
F2100 − 11 (2018)
6
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
...
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