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ASTM F2100-07

(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 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 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.
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-Jan-2007
ICS
11.140 - Hospital equipment
Technical Committee
F23 - Personal Protective Clothing and Equipment
Drafting Committee
F23.40 - Biological
Current Stage
Ref Project

Relations

Replaces
ASTM F2100-04 - Standard Specification for Performance of Materials Used in Medical Face Masks
Effective Date
01-Feb-2007
Replaced By
ASTM F2100-11 - Standard Specification for Performance of Materials Used in Medical Face Masks
Effective Date
01-Apr-2011
Referred By
ASTM F3502-23a - Standard Specification for Barrier Face Coverings
Effective Date
01-Feb-2007

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ASTM F2100-07 - Standard Specification for Performance of Materials Used in Medical Face MasksASTM F2100-07 - Standard Specification for Performance of Materials Used in Medical Face Masks
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ASTM F2100-07 - Standard Specification for Performance of Materials Used in Medical Face Masks
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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 – 07
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 F2101 Test Method for Evaluating the Bacterial Filtration
Efficiency (BFE) of Medical Face Mask Materials, Using a
1.1 This specification covers testing and requirements for
Biological Aerosol of Staphylococcus aureus
materials used in the construction of medical face masks that
F2299 TestMethodforDeterminingtheInitialEfficiencyof
are used in providing health care services such as surgery and
Materials Used in Medical Face Masks to Penetration by
patient care.
Particulates Using Latex Spheres
1.2 This specification provides for the classification of
3
2.2 ANSI/ASQC Standard:
medical face mask material performance. Medical face mask
ANSI/ASQC Z1.4 Sampling Procedures and Tables for
material performance is based on testing for bacterial filtration
Inspection by Attributes
efficiency, differential pressure, sub-micron particulate filtra-
4
2.3 ISO Standard:
tionefficiency,resistancetopenetrationbysyntheticblood,and
ISO 2859-1 Sampling Plans for Inspection by Attributes
flammability.
5
2.4 Military Standard:
1.3 This specification does not address all aspects of medi-
MIL-M-36954C Military Specification, Mask, Surgical,
cal face mask design and performance. This specification does
Disposable
notspecificallyevaluatetheeffectivenessofmedicalfacemask
6
2.5 Federal Standards:
designs as related to the barrier and breathability properties.
16 CFR Part 1610 Standard for the Flammability of Cloth-
This specification does not also apply to respiratory protection,
ing Textiles
which may be necessary for some health care services.
29 CFR Part 1910.1030 Occupational Exposure to Blood-
1.4 The values stated in SI units or in other units shall be
borne Pathogens: Final Rule
regarded separately as standard. The values stated in each
42 CFR Part 84 Approval of Respiratory Protective Devices
system must be used independently of the other, without
combining values in any way.
3. Terminology
1.5 The following precautionary caveat pertains only to the
3.1 Definitions:
test methods portion, Section 9, of this specification: This
3.1.1 bacterial filtration effıciency (BFE), n—the effective-
standard does not purport to address all of the safety concerns,
nessofmedicalfacemaskmaterialinpreventingthepassageof
if any, associated with its use. It is the responsibility of the user
aerosolized bacteria; expressed in the percentage of a known
of this standard to establish appropriate safety and health
quantity that does not pass the medical face mask material at a
practices and determine the applicability of regulatory limita-
given aerosol flow rate.
tions prior to use.
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
2. Referenced Documents creted by the human body.
2
3.1.2.1 Discussion—In this specification, body fluids in-
2.1 ASTM Standards:
clude liquids potentially infected with blood-borne pathogens,
F1494 Terminology Relating to Protective Clothing
including, but not limited to, blood, semen, vaginal secretions,
F1862 Test Method for Resistance of Medical Face Masks
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
toPenetrationbySyntheticBlood(HorizontalProjectionof
otic fluid, saliva in dental procedures, and any body fluid that
Fixed Volume at a Known Velocity)
is visibly contaminated with blood, and all body fluids in
1
This specification is under the jurisdiction of ASTM Committee F23 on
Personal Protective Clothing and Equipment and is the direct responsibility of
3
Subcommittee F23.40 on Biological. Available from American Society for Quality (ASQ), 600 N. Plankinton Ave.,
Current edition approved Feb. 1, 2007. Published February 2007. Originally Milwaukee, WI 53203.
4
approved in 2001. Last previous edition approved in 2004 as F2100 – 04. DOI: Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
10.1520/F2100-07. 4th Floor, New York, NY 10036.
2 5
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from Standardization Documents Order Desk, DODSSP, Bldg. 4,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Section D, 700 Robbins Ave., Philadelphia, PA 19111-5098
6
Standards volume information, refer to the standard’s Document Summary page on AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
the ASTM website. 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401.
Copyright © ASTM International, 100
...

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This specification establishes the requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. It does not however cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. Barrier testing shall be conducted to determine the impact penetration, hydrostatic resistance, and viral penetration resistance performance of the critical zone(s) of the surgical gown. The physical properties of the critical zone(s) of the surgical gown shall also be tested and shall conform to the following requirements: tensile strength, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission rate. General safety requirements shall be set based on biocompatibility, sterility assurance, flame spread, and natural rubber latex specifications.
SIGNIFICANCE AND USE
4.1 This specification provides minimum requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying gowns established in ANSI/AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Performance requirements are established for important physical properties, including tensile strength, tear strength, and seam strength. Methods to be used for optional reporting of performance of linting resistance, evaporative resistance, water vapor transmission rate, and abrasion resistance are provided.  
4.2 This specification does not address protective clothing used for nonsurgical applications, such as isolation gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.  
4.3 Surgical gowns are either multiple-use or single-use products as designated by the manufacturer. This specification is intended to provide the basis for manufacturer claims for surgical gown performance and efficacy. For multiple-use gowns, this specification takes into account the anticipated care and maintenance of these products by examining test requirements for surgical gown materials both before and after the maximum expected number of cycles for laundering and sterilization.  
4.4 Additional information on the processing of multiple-use surgical gowns is provided in ANSI/AAMI ST65.  
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1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in healthcare facilities. Four levels of barrier properties for surgical gowns are specified in ANSI/AAMI PB70 and are included in this specification for reference purposes.
Note 1: Some properties require minimum performance and others are for documentation only.
Note 2: ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown.  
1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products.  
1.3 This specification is not intended to serve as a detailed manufacturing or purchase...

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ASTM F2100-23(Specification)
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.

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ASTM F2101-23(Test Method)
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

SIGNIFICANCE AND USE
5.1 This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition under which testing is conducted.  
5.2 This test method has been specifically designed for measuring bacterial filtration efficiency of medical face masks, using Staphylococcus aureus as the challenge organism. The use of S. aureus is based on its clinical relevance as a leading cause of nosocomial infections.  
5.3 This test method has been designed to introduce a bacterial aerosol challenge to the test specimens at a flow rate of 28.3 L/mm (1 ft3/min). This flow rate is within the range of normal respiration and within the limitations of the cascade impactor.  
5.4 Unless otherwise specified, the testing shall be performed with the inside of the medical face mask in contact with the bacterial challenge. Testing may be performed with the aerosol challenge directed through either the face side or liner side of the test specimen, thereby allowing evaluation of filtration efficiencies which relate to both patient-generated aerosols and wearer-generated aerosols.  
5.5 Degradation by physical, chemical, and thermal stresses could negatively impact the performance of the medical face mask material. The integrity of the material can also be compromised during use by such effects as flexing and abrasion, or by wetting with contaminants such as alcohol and perspiration. Testing without these stresses could lead to a false sense of security. If these conditions are of concern, evaluate the performance of the medical face mask material for bacterial filtration efficiency following an appropriate pretreatment technique representative of the expected conditions of use. Consider preconditioning to assess the impact of storage conditions and shelf life for disposable products, an...
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1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.  
1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %.  
1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications.  
1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material do not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties.  
1.5 Units—The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance of the standard.  
1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material.  
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5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.  
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5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions, as well as the usual continuous regions of protective clothing items.  
5.2 It is known that body fluids penetrating protective clothing materials are likely to carry microbiological contaminants; however, visual detection methods are not sensitive enough to detect minute amounts of liquid containing microorganisms (1-3).7 This test method uses media containing Phi-X174 Bacteriophage. The visual detection technique of this test method is supplemented with a biologically based assay capable of detecting virus under the specified test conditions.  
5.3 Test Method F1670/F1670M allows the screening of protective clothing materials for resistance to penetration with synthetic blood as a challenge liquid. Test Method F1670/F1670M uses the same penetration test cell and technique, but exposes material specimens to synthetic blood with visual detection of liquid penetration. Materials passing Test Method F1670/F1670M should then be tested against bacteriophage penetration using this test method to verify performance.  
5.4 This test method has been specifically designed for measuring penetration of a surrogate microbe for Hepatitis (B and C) and the Human Immunodeficiency Viruses. The surrogate, Phi-X174 Bacteriophage, used in this test method is similar to HCV in size and shape but also serves as a surrogate for HBV and HIV. Inferences about protection from other pathogens must be assessed on a case-by-case basi...
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1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the liquid assay fluid.  
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method should review modes for worker/clothing exposure and assess the appropriateness of this test method for their specific applications.  
1.3 This test method has been specifically defined for modeling the viral penetration of Hepatitis (B and C) and Human Immunodeficiency Viruses transmitted in blood and other potentially infectious body fluids. Inferences for protection from other pathogens must be assessed on a case-by-case basis.  
1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing and determined to be viral resistant. This test method does not address the design, overall construction and components, or interfaces of garments or other factors which may affect the overall protection offered by the protective clothing.  
1.5 The 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.  
1.6 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 i...

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ASTM F1819-19(Test Method)
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Using a Mechanical Pressure Technique

SIGNIFICANCE AND USE
5.1 This test method was modeled after a procedure commonly known as the Elbow Lean Test.8 The Elbow Lean Test involves the application of synthetic blood to an ink pad, placement of sample fabric over the blood-soaked pad, placement of a blotter over the sample fabric, and applying elbow or fingertip pressure on top of the blotter. The blotter is then examined for staining as evidence of blood penetration. This test method provides similar procedures which standardize the test equipment and application of pressure through an adopted methodology.  
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5.3 This test method uses predominately mechanical pressure as opposed to contained, hydrostatic pressure to demonstrate liquid penetration resistance (1, 2) . It simulates a single insult in which the outer surfaces of a protective clothing item are compressed at a steady rate by the wearer's body against a wet surface. This steady rate of compression represents one potential use scenario. Other scenarios may result in a wide variety of pressure ramp rates and profiles that are not simulated by the test apparatus.  
5.4 Because this test method provides quantitative results, it is useful for discriminating differences in the liquid barrier performance of protective clothing materials. This test method can be used for measuring differences in the penetration pressure for protective clothing materials which do not pass Test Method F1670/F1670M.  
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1.1 This test method is used to evaluate the resistance of materials used in protective clothing to synthetic blood under the conditions of liquid contact and increasing direct mechanical pressure. The penetration resistance of protective clothing is based on visual detection of synthetic blood penetration at a specific applied mechanical pressure.  
1.2 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.  
1.3 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction, components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.  
1.4 The values 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.  
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Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood

SIGNIFICANCE AND USE
5.1 This test method is based on Test Method F903 for measuring resistance of chemical protective clothing materials to penetration by liquids. This test method is normally used to evaluate specimens from individual finished items of protective clothing and individual samples of materials that are candidates for items of protective clothing.  
5.1.1 Finished items of protective clothing include gloves, arm shields, aprons, gowns, coveralls, hoods, and boots.  
5.1.2 The phrase “specimens from finished items” encompasses seamed and other discontinuous regions as well as the usual continuous regions of protective clothing items.  
5.2 Medical protective clothing materials are intended to be a barrier to blood, body fluids, and other potentially infectious materials. Many factors can affect the wetting and penetration characteristics of body fluids, such as surface tension, viscosity, and polarity of the fluid, as well as the structure and relative hydrophilicity or hydrophobicity of the materials. The surface tension range for blood and body fluids (excluding saliva) is approximately 0.042 to 0.060 N/m (1) .7 To help simulate the wetting characteristics of blood and body fluids, the surface tension of the synthetic blood is adjusted to approximate the lower end of this surface tension range. The resulting surface tension of the synthetic blood is approximately 0.042 ± 0.002 N/m.  
5.3 The synthetic blood mixture is prepared with a red dye to aid in visual detection and a thickening agent to simulate the flow characteristics of blood.  
5.4 Part of the protocol in Procedures A and B in Table 1 for exposing the protective clothing material specimens with synthetic blood involves pressurization of the test cell to 13.8 kPa [2 psig]. This hydrostatic pressure has been documented to discriminate between protective clothing material performance and to correlate with visual penetration results that are obtained with a human factors validation (2). Some studies, however,...
SCOPE
1.1 This test method is used to evaluate the resistance of materials used in protective clothing to penetration by synthetic blood under conditions of continuous liquid contact. Protective clothing  pass/fail determinations are based on visual detection of synthetic blood penetration.  
1.1.1 This test method is not always effective in testing protective clothing materials having thick, inner liners which readily absorb the synthetic blood.  
1.2 This test method is a means for selecting protective clothing materials for subsequent testing with a more sophisticated barrier test as described in Test Method F1671.  
1.3 This test method does not apply to all forms or conditions of blood-borne pathogen exposure. Users of the test method must review modes for work/clothing exposure and assess the appropriateness of this test method for their specific application.  
1.4 This test method addresses only the performance of materials or certain material constructions (for example, seams) used in protective clothing. This test method does not address the design, overall construction and components, or interfaces of garments, or other factors which may affect the overall protection offered by the protective clothing.  
1.5 The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard.  
1.6 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.  
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ABSTRACT
This specification establishes the requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. It does not however cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. Barrier testing shall be conducted to determine the impact penetration, hydrostatic resistance, and viral penetration resistance performance of the critical zone(s) of the surgical gown. The physical properties of the critical zone(s) of the surgical gown shall also be tested and shall conform to the following requirements: tensile strength, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission rate. General safety requirements shall be set based on biocompatibility, sterility assurance, flame spread, and natural rubber latex specifications.
SIGNIFICANCE AND USE
4.1 This specification provides minimum requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying gowns established in ANSI/AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Performance requirements are established for important physical properties, including tensile strength, tear strength, and seam strength. Methods to be used for optional reporting of performance of linting resistance, evaporative resistance, water vapor transmission rate, and abrasion resistance are provided.  
4.2 This specification does not address protective clothing used for nonsurgical applications, such as isolation gowns or decontamination gowns; protective clothing for the hands, such as surgical gloves, patient examination gloves, or other medical gloves; protective clothing for the head, such as goggles or face shields, surgical caps or hoods, surgical masks, or respirators; protective clothing for the feet, such as operating room shoes, shoe covers, or surgical boots; or other types of protective clothing and equipment worn by healthcare providers.  
4.3 Surgical gowns are either multiple-use or single-use products as designated by the manufacturer. This specification is intended to provide the basis for manufacturer claims for surgical gown performance and efficacy. For multiple-use gowns, this specification takes into account the anticipated care and maintenance of these products by examining test requirements for surgical gown materials both before and after the maximum expected number of cycles for laundering and sterilization.  
4.4 Additional information on the processing of multiple-use surgical gowns is provided in ANSI/AAMI ST65.  
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SCOPE
1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in healthcare facilities. Four levels of barrier properties for surgical gowns are specified in ANSI/AAMI PB70 and are included in this specification for reference purposes.
Note 1: Some properties require minimum performance and others are for documentation only.
Note 2: ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1, 2, and 3. Since surgical gowns are exposed to blood and other fluids with different surface tensions, the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown.  
1.2 This specification does not cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products.  
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ASTM F2100-23(Specification)
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.

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ASTM
ASTM F2101-23(Test Method)
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus

SIGNIFICANCE AND USE
5.1 This test method offers a procedure for evaluation of medical face mask materials for bacterial filtration efficiency. This test method does not define acceptable levels of bacterial filtration efficiency. Therefore, when using this test method it is necessary to describe the specific condition under which testing is conducted.  
5.2 This test method has been specifically designed for measuring bacterial filtration efficiency of medical face masks, using Staphylococcus aureus as the challenge organism. The use of S. aureus is based on its clinical relevance as a leading cause of nosocomial infections.  
5.3 This test method has been designed to introduce a bacterial aerosol challenge to the test specimens at a flow rate of 28.3 L/mm (1 ft3/min). This flow rate is within the range of normal respiration and within the limitations of the cascade impactor.  
5.4 Unless otherwise specified, the testing shall be performed with the inside of the medical face mask in contact with the bacterial challenge. Testing may be performed with the aerosol challenge directed through either the face side or liner side of the test specimen, thereby allowing evaluation of filtration efficiencies which relate to both patient-generated aerosols and wearer-generated aerosols.  
5.5 Degradation by physical, chemical, and thermal stresses could negatively impact the performance of the medical face mask material. The integrity of the material can also be compromised during use by such effects as flexing and abrasion, or by wetting with contaminants such as alcohol and perspiration. Testing without these stresses could lead to a false sense of security. If these conditions are of concern, evaluate the performance of the medical face mask material for bacterial filtration efficiency following an appropriate pretreatment technique representative of the expected conditions of use. Consider preconditioning to assess the impact of storage conditions and shelf life for disposable products, an...
SCOPE
1.1 This test method is used to measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.  
1.2 This test method is a quantitative method that allows filtration efficiency for medical face mask materials to be determined. The maximum filtration efficiency that can be determined by this method is 99.9 %.  
1.3 This test method does not apply to all forms or conditions of biological aerosol exposure. Users of the test method should review modes for worker exposure and assess the appropriateness of the method for their specific applications.  
1.4 This test method evaluates medical face mask materials as an item of protective clothing but does not evaluate materials for regulatory approval as respirators. If respiratory protection for the wearer is needed, a NIOSH-certified respirator should be used. Relatively high bacterial filtration efficiency measurements for a particular medical face mask material do not ensure that the wearer will be protected from biological aerosols, since this test method primarily evaluates the performance of the composite materials used in the construction of the medical face mask and not its design, fit, or facial-sealing properties.  
1.5 Units—The values stated in SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance of the standard.  
1.6 This test method does not address breathability of the medical face mask materials or any other properties affecting the ease of breathing through the medical face mask material.  
1.7 This test method may also be used to measure the bacterial filtration efficienc...

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ASTM
ASTM F2076-01(2022)(Practice)
Standard Practice for Communicating an EMS Patient Report to Receiving Medical Facilities

SIGNIFICANCE AND USE
4.1 This practice establishes the national standard for training the EMT in communicating pertinent patient information to the receiving medical facility.  
4.2 Appropriate physiological data and patient assessment information should be collected from the scene or while en route to the receiving medical facility or medical command site.  
4.3 This practice is based on the information needs of a receiving medical facility to assist them in medical triage, ED resource management, and the provision of medical direction.  
4.4 This practice should be used by those who develop curricula, provide continuing medical education, or desire a needs-based reporting approach.  
4.5 This practice should be used to develop documentation aids such as EMS notepads and medical command documentation sheets.  
4.6 The communication format in each PISA subsection in this practice are not necessarily in sequential order. The report may vary dependent upon patient presentation.
SCOPE
1.1 This practice establishes the EMS standard for communications entailing a patient radio (phone) report to a receiving medical facility.  
1.1.1 This report is based on receiving facility needs and is generic for medical, traumatic (ALS), and (BLS) patients.  
1.1.2 This report standard is based on the hierarchical information needs of an average medical receiving facility.  
1.2 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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