ASTM F2100-23

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.  
1.1.1 This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks).  
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 their overall barrier and breathability properties.  
1.3.1 This specification does not include any specific design criteria for medical face masks; however, surgical masks are differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which use ear loops to affix the mask to the wearer’s face.  
1.4 This specification does not address requirements for regulated respiratory protection devices such as respirators, which may be necessary for some healthcare services and exposure to inhalation hazards.
Note 1: Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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.  
1.7 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: Published
• Publication Date: 28-Feb-2023
• ICS: 11.140 - Hospital equipment
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Refers: ASTM F3502-24 - Standard Specification for Barrier Face Coverings
• Effective Date: 01-Feb-2024
• Refers: ASTM F2101-14 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency &#40;BFE&#41; of Medical Face Mask Materials, Using a Biological Aerosol of <emph type="ital" >Staphylococcus aureus</emph>
• Effective Date: 01-Jul-2014
• Refers: ASTM F1494-13 - Standard Terminology Relating to Protective Clothing
• Effective Date: 01-Jul-2013
• Refers: ASTM F1494-03(2011) - Standard Terminology Relating to Protective Clothing
• Effective Date: 01-Feb-2011
• Refers: 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
• Refers: ASTM F1862-07 - 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: 01-Feb-2007
• Refers: ASTM F1862-05 - 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: 15-Sep-2005
• Refers: ASTM F1494-03 - Standard Terminology Relating to Protective Clothing
• Effective Date: 10-Jul-2003
• Refers: ASTM F1494-01 - Standard Terminology Relating to Protective Clothing
• Effective Date: 10-Jun-2001
• Refers: ASTM F1494-99 - Standard Terminology Relating to Protective Clothing
• Effective Date: 10-Jun-2001
• Refers: 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>
• Effective Date: 10-Apr-2001
• Refers: ASTM F1862-00a - 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-Jul-2000

Overview

ASTM F2100-23: Standard Specification for Performance of Materials Used in Medical Face Masks is a key international standard developed by ASTM International. This specification outlines the classification, performance requirements, and testing methods for materials used in the construction of medical face masks, such as those used in healthcare settings for surgery and patient care. By establishing minimum performance criteria, ASTM F2100-23 helps ensure that medical masks provide adequate protection against the penetration of fluids and bacteria while maintaining the necessary breathability and flammability requirements.

Key Topics

Performance Requirements
The standard establishes performance criteria for medical face mask materials based on:

• Bacterial Filtration Efficiency (BFE): Measures the effectiveness of mask materials in preventing the passage of bacteria.
• Differential Pressure (ΔP): Assesses breathability by measuring the pressure drop across the mask material.
• Sub-micron Particulate Filtration Efficiency: Evaluates the mask’s capability to filter particles smaller than one micron.
• Resistance to Penetration by Synthetic Blood: Tests material resistance to fluid penetration, simulating exposure to blood and other body fluids.
• Flammability: Ensures that mask materials meet minimum flammability requirements for safety.

Classification Levels

• Level 1 Barrier: Minimum protection for general procedures and low-risk patient care.
• Level 2 Barrier: Moderate protection suitable for procedures with a moderate risk of fluid exposure.
• Level 3 Barrier: Maximum barrier protection for high-risk situations with high fluid exposure potential.

Test Methods and Conformity

• Testing must be conducted according to specific ASTM test methods, such as F1862 for fluid resistance and F2101 for bacterial filtration.
• Laboratories performing these tests must be accredited to ISO/IEC 17025.

Scope Limitations

• The standard does not address every aspect of medical face mask design, effectiveness related to fit, or regulatory criteria for respiratory protection such as N95 respirators.

Applications

ASTM F2100-23 is widely used by:

• Mask Manufacturers: To develop, test, and label medical face masks that meet recognized performance levels.
• Healthcare Facilities: For selecting appropriate face masks for surgical staff, patient care, and isolation purposes based on specific performance needs.
• Quality Assurance and Procurement: To ensure that ordered masks meet stringent material performance requirements for infection control and patient safety.
• Regulatory and Testing Labs: For conformity assessment, product certification, and compliance documentation.

Typical applications include:

• Surgical masks for operating rooms and procedural areas
• Procedure masks for patient care areas and general medical use
• Isolation masks for patient or visitor use in healthcare facilities

Related Standards

Several key standards are referenced in ASTM F2100-23 for testing and compliance, including:

• ASTM F1862: Resistance of medical face masks to penetration by synthetic blood
• ASTM F2101: Bacterial filtration efficiency of medical face mask materials
• ASTM F2299: Sub-micron particulate filtration efficiency
• EN 14683: European standard for medical face mask requirements and test methods
• ISO 10993-1: Biological evaluation of medical devices
• 16 CFR Part 1610: Flammability of clothing textiles
• ISO/IEC 17025: Competence of testing and calibration laboratories

Keywords: ASTM F2100, medical face masks, surgical masks, barrier mask standards, bacterial filtration efficiency, particulate filtration, synthetic blood resistance, healthcare PPE, mask performance levels, conformity assessment

Standards Content (Sample)

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.
Designation: F2100 − 23
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 1.5 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
1.1 This specification covers testing and requirements for
standard.
materials used in the construction of medical face masks that
1.6 The following precautionary caveat pertains only to the
are used in providing healthcare services such as surgery and
test methods portion, Section 9, of this specification: This
patient care.
standard does not purport to address all of the safety concerns,
1.1.1 This specification addresses medical masks with ties
if any, associated with its use. It is the responsibility of the user
(surgical masks) and ear loops (procedure masks or isolation
of this standard to establish appropriate safety, health, and
masks).
environmental practices and determine the applicability of
1.2 This specification provides for the classification of regulatory limitations prior to use.
medical face mask material performance. Medical face mask 1.7 This international standard was developed in accor-
material performance is based on testing for bacterial filtration dance with internationally recognized principles on standard-
efficiency, differential pressure, sub-micron particulate filtra- ization established in the Decision on Principles for the
tion efficiency, resistance to penetration by synthetic blood, and Development of International Standards, Guides and Recom-
flammability. mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
1.3 This specification does not address all aspects of medi-
cal face mask design and performance. This specification does
2. Referenced Documents
not specifically evaluate the effectiveness of medical face mask
2.1 ASTM Standards:
designs as related to their overall barrier and breathability
F1494 Terminology Relating to Protective Clothing
properties.
F1862 Test Method for Resistance of Medical Face Masks to
1.3.1 This specification does not include any specific design
Penetration by Synthetic Blood (Horizontal Projection of
criteria for medical face masks; however, surgical masks are
Fixed Volume at a Known Velocity)
differentiated by having ties to allow adjustment of the medical
F2101 Test Method for Evaluating the Bacterial Filtration
face mask fit in comparison to procedure or isolation masks,
Efficiency (BFE) of Medical Face Mask Materials, Using
which use ear loops to affix the mask to the wearer’s face.
a Biological Aerosol of Staphylococcus aureus
1.4 This specification does not address requirements for F3050 Guide for Conformity Assessment of Personal Pro-
regulated respiratory protection devices such as respirators,
tective Clothing and Equipment
which may be necessary for some healthcare services and F3502 Specification for Barrier Face Coverings
exposure to inhalation hazards.
2.2 ANSI/ASQC Standard:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for In-
NOTE 1—Performance requirements for NIOSH-approved N95 respira-
spection by Attributes
tors are described in 42 CFR Part 84. Additional requirements for
NIOSH-approved N95 respirators intended for use in healthcare settings
2.3 ISO Standards:
are described in the Memorandum of Understanding between FDA and
ISO 2859-1 Sampling Plans for Inspection by Attributes
NIOSH. FDA/NIOSH MOU 225-18-006, November 2017 and the NIOSH
ISO 10993-1 Biological Evaluation of Medical Devices—
Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010,
November 2018.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
This specification is under the jurisdiction of ASTM Committee F23 on Standards volume information, refer to the standard’s Document Summary page on
Personal Protective Clothing and Equipment and is the direct responsibility of the ASTM website.
Subcommittee F23.40 on Biological. Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Current edition approved March 1, 2023. Published March 2023. Originally Milwaukee, WI 53203, http://www.asq.org.
approved in 2001. Last previous edition approved in 2021 as F2100 – 21. DOI: Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2100-23. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2100 − 23
Part 1: Evaluation and Testing Within a Risk Management 3.1.7 medical face mask, n—an item of protective clothing
Process designed to protect portions of the wearer’s face, including the
ISO 10993-5 Biological Evaluation of Medical Devices— mucous membrane areas of the wearer’s nose and mouth, from
Part 5: Tests for in vitro Cytotoxicity contact with blood and other body fluids during medical
ISO 10993-10 Biological Evaluation of Medical Devices— procedures.
Part 10: Tests for Irritation and Skin Sensitization
3.1.7.1 Discussion—Examples of medical face masks in-
ISO 10993-23 Biological Evaluation of Medical Devices—
clude surgical masks, procedure masks, isolation masks, laser
Part 23: Tests for Irritation
masks, dental masks, and patient care masks.
ISO/IEC 17025 General Requirements for the Competence
3.1.8 penetration, n—in a protective clothing material or
of Testing and Calibration Laboratories
item, the flow of a chemical on a non-molecular level through
ISO/IEC 17026 Conformity Assessment—Example of a
closures, porous materials, seams and pinholes, or other
Certification Scheme for Tangible Products
imperfections in protective clothing.
2.4 European Standard:
3.1.8.1 Discussion—In this specification, blood or body
EN 14683 Medical Face Masks—Requirements and Test
fluids replace the term chemical and the specific penetration
Methods
liquid is synthetic blood, a body fluid simulant.
2.5 Federal Standards:
16 CFR Part 1610 Standard for the Flammability of Clothing
3.1.9 procedure mask, n—a medical face mask that is used
Textiles
for performing patient procedures, or when patients are in
21 CFR Section 878.4040 Surgical Apparel
isolation to protect them or their surroundings from potential
29 CFR Part 1910.1030 Occupational Exposure to Blood-
contaminants.
Borne Pathogens: Final Rule
3.1.9.1 Discussion—Procedure masks are used to protect
42 CFR Part 84 Approval of Respiratory Protective Devices
both patients and staff from the transfer of respiratory
secretions, fluids, or other debris. Procedure masks are used for
3. Terminology
generally “respiratory etiquette” to prevent clinicians, patients,
3.1 Definitions:
and visitors from spreading germs by talking, coughing, or
3.1.1 bacterial filtration effıciency (BFE), n—the effective-
sneezing. They may also be used for source control. Procedure
ness of medical face mask material in preventing the passage of
masks have ear loops for easier donning and doffing.
aerosolized bacteria, expressed in the percentage of a known
3.1.10 protective clothing, n—an item of clothing that is
quantity that does not pass the medical face mask material at a
specifically designed and constructed for the intended purpose
given aerosol flow rate.
of isolating all or part of the body from a potential hazard; or,
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
isolating the external environment from contamination by the
creted by the human body.
wearer of the clothing.
3.1.2.1 Discussion—In this specification, body fluids in-
3.1.10.1 Discussion—The primary purpose of protective
clude liquids potentially infected with blood-borne pathogens,
clothing is to act as a barrier for the wearer to a hazard.
including, but not limited to: blood, semen, vaginal secretions,
However, the product may also offer protection as a barrier
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
which prevents the body from being a source of contamination.
otic fluid, saliva in dental procedures, any body fluid that is
3.1.11 respirator, n—a personal protective device that is
visibly contaminated with blood, and all body fluids in situa-
worn on the face, covers at least the nose and mouth, and is
tions where it is difficult or impossible to differentiate between
used to reduce the wearer’s risk of inhaling airborne hazards
body fluids (see 29 CFR Part 1910.1030).
such as particles, gases, or vapors. Respirators are regulated
3.1.3 body fluid simulant, n—a liquid which is used to act as
devices and must be approved by the applicable agency, such
a model for human body fluids.
as the National Institute for Occupational Safety and Health
3.1.4 differential pressure, n—the measured pressure drop
(NIOSH), in accordance with the specific regulation in 42 CFR
across a medical face mask material.
Part 84.
3.1.4.1 Discussion—In this specification, differential pres-
3.1.11.1 Discussion—Healthcare workers can be instructed
sure is expressed as a force per unit area.
to wear disposable half-mask filtering facepiece respirators
3.1.5 flammability, n—those characteristics of a material
with N95 or higher levels of filtration efficiency as defined in
that pertain to its relative ease of ignition and relative ability to
42 CFR Part 84 in situations with an elevated risk of exposure
sustain combustion.
to airborne pathogenic biological particulates. See also defini-
tion for surgical N95 respirator.
3.1.6 isolation mask, n—another name for a procedure
mask, particularly in reference to ear loop masks worn by
3.1.12 source control, n—the use of a medical face mask or
patients.
other device covering the wearer’s nose and mouth that is
primarily intended to contain the wearer’s respiratory secre-
Available from British Standards Institution (BSI), 389 Chiswick High Rd., tions to help prevention the transmission from infected indi-
London W4 4AL, U.K., http://www.bsigroup.com.
viduals who may or may not have symptoms of a specific
Available from U.S. Government Printing Office Superintendent of Documents,
respiratory disease.
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov. 3.1.12.1 Discussion—Medical faces masks provide a level
F2100 − 23
of source control when worn properly and meeting the require- (CDC) specifically recommends NIOSH respirators that are at
ments in this specification. least 95 % efficient for tuberculosis exposure control.
NOTE 2—This specification does not provide specific criteria for
3.1.13 sub-micron particulate filtration effıciency, n—the
demonstrating medical face mask protection of the patient.
efficiency of the filter material in capturing aerosolized par-
NOTE 3—The level of protection provided by medical face masks
ticles smaller than one micron, expressed as the percentage of
depends on several factors not considered in this specification. Examples
a known number of particles that do not pass through the
include facial fit and material degradation from wearer challenges
(perspiration, talking, sneezing, and the length of time the medical face
medical face mask material at a given flow rate or face
mask is worn).
velocity.
4.3 Users of this specification are cautioned that improved
3.1.14 surgical mask, n—a medical face mask that is used
resistance of medical face masks to penetration by synthetic
inside the operating room or within other sterile procedure
blood can cause a reduction in medical face mask breathability.
areas to protect the patient environment from contamination.
In general, increasing synthetic blood penetration resistance
3.1.14.1 Discussion—Surgical masks also protect the clini-
(and bacterial filtration efficiency and sub-micron particulate
cian from contaminated fluid or debris generated during the
filtration efficiency) results in increasing pressure drop or
procedure. Surgical masks have ties so that they can be
reduction of breathability for medical face masks of the same
adjusted for fit, and are tied over top of a surgical cap or a
design.
bouffant cap.
4.4 This specification is intended to provide the function of
source control for materials used in the construction medical
3.1.15 surgical N95 respirator, n—a respirator that is ap-
face masks, but does not include any specific criteria that relate
proved by NIOSH and is cleared by the U.S. Food and Drug
to the design and fit of medical face masks on individual
Administration (FDA) as a Class II medical device under 21
wearers that allows an assessment of overall medical face mask
CFR Secti
...

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 − 21 F2100 − 23
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 healthcare services such as surgery and patient care.
1.1.1 This specification addresses medical masks with ties (surgical masks) and ear loops (procedure masks or isolation masks).
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 their overall barrier and breathability properties.
1.3.1 This specification does not include any specific design criteria for medical face masks; however, surgical masks are
differentiated by having ties to allow adjustment of the medical face mask fit in comparison to procedure or isolation masks, which
use ear loops to affix the mask to the wearer’s face.
1.4 This specification does not address requirements for regulated respiratory protection devices such as respirators, which may
be necessary for some healthcare services and exposure to inhalation hazards.
NOTE 1—Performance requirements for NIOSH-approved N95 respirators are described in 42 CFR Part 84. Additional requirements for NIOSH-approved
N95 respirators intended for use in healthcare settings are described in the Memorandum of Understanding between FDA and NIOSH. FDA/NIOSH MOU
225-18-006, November 2017 and the NIOSH Conformity Assessment Letter to Manufacturers, NIOSH CA 2018-1010, November 2018.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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.
1.7 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.
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 Aug. 1, 2021March 1, 2023. Published August 2021March 2023. Originally approved in 2001. Last previous edition approved in 20202021 as
F2100 – 20.F2100 – 21. DOI: 10.1520/F2100-21.10.1520/F2100-23.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2100 − 23
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
F3050 Guide for Conformity Assessment of Personal Protective Clothing and Equipment
F3502 Specification for Barrier Face Coverings
2.2 ANSI/ASQC Standard:
ANSI/ASQC Z1.4 Sampling Procedures and Tables for Inspection by Attributes
2.3 ISO Standards:
ISO 2859-1 Sampling Plans for Inspection by Attributes
ISO 10993-1 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process
ISO 10993-5 Biological Evaluation of Medical Devices—Part 5: Tests for in vitro Cytotoxicity
ISO 10993-10 Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-23 Biological Evaluation of Medical Devices—Part 23: Tests for Irritation
ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
ISO/IEC 17026 Conformity Assessment—Example of a Certification Scheme for Tangible Products
2.4 European Standard:
EN 14683 Medical Face Masks—Requirements and Test Methods
2.5 Federal Standards:
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
21 CFR Section 878.4040 Surgical Apparel
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, 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,
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 force per unit area.
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.
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 British Standards Institution (BSI), 389 Chiswick High Rd., London W4 4AL, U.K., http://www.bsigroup.com.
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 − 23
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 isolation mask, n—another name for a procedure mask, particularly in reference to ear loop masks worn by patients.
3.1.7 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.
3.1.7.1 Discussion—
Examples of medical face masks include surgical masks, procedure masks, isolation masks, laser masks, dental masks, and patient
care masks.
3.1.8 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.
3.1.8.1 Discussion—
In this specification, blood or body fluids replace the term chemical and the specific penetration liquid is synthetic blood, a body
fluid simulant.
3.1.9 procedure mask, n—a medical face mask that is used for performing patient procedures, or when patients are in isolation to
protect them or their surroundings from potential contaminants.
3.1.9.1 Discussion—
Procedure masks are used to protect both patients and staff from the transfer of respiratory secretions, fluids, or other debris.
Procedure masks are used for generally “respiratory etiquette” to prevent clinicians, patients, and visitors from spreading germs
by talking, coughing, or sneezing. They may also be used for source control. Procedure masks have ear loops for easier donning
and doffing.
3.1.10 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.
3.1.10.1 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.
3.1.11 respirator, n—a personal protective device that is worn on the face, covers at least the nose and mouth, and is used to reduce
the wearer’s risk of inhaling airborne hazards such as particles, gases, or vapors. Respirators are regulated devices and must be
approved by the applicable agency, such as the National Institute for Occupational Safety and Health (NIOSH), in accordance with
the specific regulation in 42 CFR Part 84.
3.1.11.1 Discussion—
Healthcare workers can be instructed to wear disposable half-mask filtering facepiece respirators with N95 or higher levels of
filtration efficiency as defined in 42 CFR Part 84 in situations with an elevated risk of exposure to airborne pathogenic biological
particulates. See also definition for surgical N95 respirator.
3.1.12 source control, n—the use of a medical face mask or other device covering the wearer’s nose and mouth that is primarily
intended to contain the wearer’s respiratory secretions to help prevention the transmission from infected individuals who may or
may not have symptoms of a specific respiratory disease.
3.1.12.1 Discussion—
Medical faces masks provide a level of source control when worn properly and meeting the requirements in this specification.
3.1.13 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 do not pass through the medical face mask
material at a given flow rate or face velocity.
3.1.14 surgical mask, n—a medical face mask that is used inside the operating room or within other sterile procedure areas to
protect the patient environment from contamination.
3.1.14.1 Discussion—
F2100 − 23
Surgical masks also protect the clinician from contaminated fluid or debris generated during the procedure. Surgical masks have
ties so that they can be adjusted for fit, and are tied over top of a surgical cap or a bouffant cap.
3.1.15 surgical N95 respirator, n—a respirator that is approved by NIOSH and is cleared by the U.S. Food and Drug
Administration (FDA) as a Class II medical device under 21 CFR Section 878.4040.
3.1.15.1 Discussion—
Surgical N95 respirators are N95 disposable filtering facepiece respirators that are approved under 42 CFR Part 84 criteria and meet
additional performance criteria for material biocompatibility, fluid resistance, and flammability as required by the FDA.
3.1.16 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.
3.1.16.1 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 method, refer to Terminology F1494.
4. Significance and Use
4.1 This specification covers the minimum performance requirements for materials used in the construction of medical face masks.
4.1.1 For the purposes of this specification, medical face masks include surgical masks and procedure masks.
4.2 This specification provides classification of performance for a range
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