ASTM F2100-19

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 apply to regulated 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.

General Information

• Status: Historical
• Publication Date: 31-Jul-2019
• ICS: 11.140 - Hospital equipment
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Replaces: ASTM F2100-11(2018) - Standard Specification for Performance of Materials Used in Medical Face Masks
• Effective Date: 01-Aug-2019
• Referred By: ASTM F3502-23a - Standard Specification for Barrier Face Coverings
• Effective Date: 01-Aug-2019

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 −19
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
efficiency, differential pressure, sub-micron particulate filtra-
F2299 Test Method for Determining the Initial Efficiency of
tionefficiency,resistancetopenetrationbysyntheticblood,and
Materials Used in Medical Face Masks to Penetration by
flammability.
Particulates Using Latex Spheres
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 apply to regulated respiratory
5
2.4 European Standard:
protection, which may be necessary for some healthcare
EN 14683 Medical Fask Masks—Requirements and Test
services.
Methods
6
1.4 The values stated in SI units are to be regarded as
2.5 Federal Standards:
standard. No other units of measurement are included in this
16CFRPart1610 StandardfortheFlammabilityofClothing
standard.
Textiles
29 CFR Part 1910.1030 Occupational Exposure to Blood-
1.5 The following precautionary caveat pertains only to the
borne Pathogens: Final Rule
test methods portion, Section 9, of this specification: This
42 CFR Part 84 Approval of Respiratory Protective Devices
standard does not purport to address all of the safety concerns,
if any, associated with its use. It is the responsibility of the user
3. Terminology
of this standard to establish appropriate safety, health, and
3.1 Definitions:
environmental practices and determine the applicability of
3.1.1 bacterial filtration effıciency (BFE), n—the effective-
regulatory limitations prior to use.
nessofmedicalfacemaskmaterialinpreventingthepassageof
1.6 This international standard was developed in accor-
aerosolized bacteria, expressed in the percentage of a known
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
Development of International Standards, Guides and Recom-
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
mendations issued by the World Trade Organization Technical
Standards volume information, refer to the standard’s Document Summary page on
Barriers to Trade (TBT) Committee.
the ASTM website.
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.,
1
This specification is under the jurisdiction of ASTM Committee F23 on 4th Floor, New York, NY 10036, http://www.ansi.org.
5
Personal Protective Clothing and Equipment and is the direct responsibility of Available from British Standards Institution (BSI), 389 Chiswick High Rd.,
Subcommittee F23.40 on Biological. London W4 4AL, U.K., http://www.bsigroup.com.
6
Current edition approved Aug. 1, 2019. Published August 2019. Originally AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
approved in 2001. Last previous edition approved in 2018 as F2100 – 11 (2018). 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
DOI: 10.1520/F2100-19. www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2100−19
quantity that does not pass the medical face mask material at
...

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 (Reapproved 2018) F2100 − 19
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 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 regulated 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.
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 MilitaryEuropean Standard:
MIL-M-36954CEN 14683 Military Specification, Mask, Surgical, DisposableMedical Fask Masks—Requirements and Test
Methods
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 Jan. 1, 2018Aug. 1, 2019. Published January 2018August 2019. Originally approved in 2001. Last previous edition approved in 20112018 as
F2100 – 11.F2100 – 11 (2018). DOI: 10.1520/F2100-11R18.10.1520/F2100-19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM 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.British
Standards Institution (BSI), 389 Chiswick High Rd., London W4 4AL, U.K., http://www.bsigroup.com.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2100 − 19
6
2.5 Federal Standards:
16 CFR Part 1610 Standard for
...