ASTM F2100-11

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 health care 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 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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 31-Mar-2011
• ICS: 11.140 - Hospital equipment
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Replaces: ASTM F2100-07 - Standard Specification for Performance of Materials Used in Medical Face Masks
• Effective Date: 01-Apr-2011
• Replaced By: ASTM F2100-11(2018) - Standard Specification for Performance of Materials Used in Medical Face Masks
• Effective Date: 01-Jan-2018
• Referred By: ASTM F3502-23a - Standard Specification for Barrier Face Coverings
• Effective Date: 01-Apr-2011

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:F2100 −11
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 Fixed Volume at a Known Velocity)
F2101 Test Method for Evaluating the Bacterial Filtration
1.1 This specification covers testing and requirements for
Efficiency (BFE) of Medical Face Mask Materials, Using
materials used in the construction of medical face masks that
a Biological Aerosol of Staphylococcus aureus
are used in providing health care services such as surgery and
F2299 Test Method for Determining the Initial Efficiency of
patient care.
Materials Used in Medical Face Masks to Penetration by
1.2 This specification provides for the classification of
Particulates Using Latex Spheres
medical face mask material performance. Medical face mask 3
2.2 ANSI/ASQC Standard:
material performance is based on testing for bacterial filtration
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
efficiency, differential pressure, sub-micron particulate filtra-
spection by Attributes
tionefficiency,resistancetopenetrationbysyntheticblood,and
4
2.3 ISO Standard:
flammability.
ISO 2859-1 Sampling Plans for Inspection by Attributes
5
1.3 This specification does not address all aspects of medi-
2.4 Military Standard:
cal face mask design and performance. This specification does
MIL-M-36954C MilitarySpecification,Mask,Surgical,Dis-
notspecificallyevaluatetheeffectivenessofmedicalfacemask
posable
6
designs as related to the barrier and breathability properties.
2.5 Federal Standards:
This specification does not also apply to respiratory protection,
16CFRPart1610 StandardfortheFlammabilityofClothing
which may be necessary for some health care services.
Textiles
29 CFR Part 1910.1030 Occupational Exposure to Blood-
1.4 The values stated in SI units are to be regarded as
borne Pathogens: Final Rule
standard. No other units of measurement are included in this
42 CFR Part 84 Approval of Respiratory Protective Devices
standard.
1.5 The following precautionary caveat pertains only to the
3. Terminology
test methods portion, Section 9, of this specification: This
3.1 Definitions:
standard does not purport to address all of the safety concerns,
3.1.1 bacterial filtration effıciency (BFE), n—the effective-
if any, associated with its use. It is the responsibility of the user
nessofmedicalfacemaskmaterialinpreventingthepassageof
of this standard to establish appropriate safety and health
aerosolized bacteria; expressed in the percentage of a known
practices and determine the applicability of regulatory limita-
quantity that does not pass the medical face mask material at a
tions prior to use.
given aerosol flow rate.
2. Referenced Documents
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
2
creted by the human body.
2.1 ASTM Standards:
F1494 Terminology Relating to Protective Clothing 3.1.2.1 Discussion—In this specification, body fluids in-
clude liquids potentially infected with blood-borne pathogens,
F1862 TestMethodforResistanceofMedicalFaceMasksto
Penetration by Synthetic Blood (Horizontal Projection of including, but not limited to, blood, semen, vaginal secretions,
1 3
This specification is under the jurisdiction of ASTM Committee F23 on Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Personal Protective Clothing and Equipment and is the direct responsibility of Milwaukee, WI 53203, http://www.asq.org.
4
Subcommittee F23.40 on Biological. Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
Current edition approved April 1, 2011. Published April 2011. Originally 4th Floor, New York, NY 10036, http://www.ansi.org.
5
approved in 2001. Last previous edition approved in 2007 as F2100 – 07. DOI: Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
10.1520/F2100-11. Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098, http://
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or dodssp.daps.dla.mil.
6
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
Standards volume information, refer to the standard’s Document Summary page on 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
the ASTM website. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2100−11
cerebrospinal fluid,
...

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F2100–07 Designation: F2100 – 11
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 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 services.
1.4The values stated in SI units or in other units shall be regarded separately as standard.The values stated in each system must
be used independently of the other, without combining values in any way.
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 and health practices and determine the applicability of regulatory limitations prior to use.
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 TestMethodforEvaluatingtheBacterialFiltrationEfficiency(BFE)ofMedicalFaceMaskMaterials,UsingaBiological
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
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 of Respiratory Protective Devices
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 Feb.April 1, 2007.2011. Published February 2007.April 2011. Originally approved in 2001. Last previous edition approved in 20042007 as
F2100 – 047. DOI: 10.1520/F2100-07.10.1520/F2100-11.
2
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. 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.
6
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

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F2100 – 11
3. Terminology
3.
...