ASTM F2407/F2407M-23a
(Specification)Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
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.
4.5 While surgical gowns are classified for barrier performance...
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.
1.3 This specification is not intended to serve as a detailed manufacturing or purchase...
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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: F2407/F2407M − 23a
Standard Specification for
1
Surgical Gowns Intended for Use in Healthcare Facilities
This standard is issued under the fixed designation F2407/F2407M; 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.
INTRODUCTION
Healthcare workers can be exposed to biological fluids capable of transmitting diseases. These
diseases, which may be caused by a variety of microorganisms, can pose significant risks to life and
health. This is especially true of blood-borne pathogens, such as Hepatitis (Hepatitis B Virus (HBV)
and Hepatitis C Virus (HCV)) and Human Immunodeficiency Virus (HIV). Since engineering controls
cannot eliminate all possible exposures, attention is placed on reducing the potential of direct skin
contact with microorganisms, body fluids, and other potentially infectious materials through the use
of protective apparel.
Healthcare protective clothing, including surgical gowns, is worn by healthcare workers to protect
both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and other
contaminants from one person to another.
This specification addresses the performance of surgical gowns designed to preserve the sterile field
and/or protect against exposure of healthcare workers to blood, body fluids, and other potentially
infectious materials during surgery and other healthcare procedures.
This specification establishes uniform testing and reporting requirements for surgical gown
manufacturers in order to provide information to end users that can be used in making informed
decisions in the selection and purchase of surgical gowns according to the anticipated exposures. This
information is also useful for helping end users comply with the Occupational Safety and Health
Administration’s blood-borne pathogen standard (29 CFR 1910.1030).
1. Scope 1.2 This specification does not cover all the requirements
that a healthcare facility deems necessary to select a product,
1.1 This specification establishes requirements for the
nor does it address criteria for evaluating experimental prod-
performance, documentation, and labeling of surgical gowns
ucts.
used in healthcare facilities. Four levels of barrier properties
for surgical gowns are specified in ANSI/AAMI PB70 and are
1.3 This specification is not intended to serve as a detailed
included in this specification for reference purposes.
manufacturing or purchase specification, but can be referenced
in purchase specifications as the basis for selecting test
NOTE 1—Some properties require minimum performance and others are
for documentation only.
requirements.
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
1.4 The values stated in SI units or in other units shall be
are exposed to blood and other fluids with different surface tensions, the
regarded separately as standard. The values stated in each
performance of additional testing to identify the barrier levels to simulated
system must be used independently of the other, without
biological fluids is required for a Level 4 gown.
combining values in any way.
1
1.5 This standard does not purport to address all of the
This specification is under the jurisdiction of ASTM Committee F23 on
Personal Protective Clothing and Equipment and is the direct responsibility of safety concerns, if any, associated with its use. It is the
Subcommittee F23.40 on Biological.
responsibility of the user of this standard to establish appro-
Current edition approved June 1, 2023. Published July 2023. Originally approved
priate safety, health, and environmental practices and deter-
in 2006. Last previous edition approved in 2023 as F2407/F2407M – 23. DOI:
10.1520/F2407_F2407M-23A. mine the applicability of regulatory limitations prior to use.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
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F2407/F2407M − 23a
5
1.6 This international standard was developed in accor- 2.4 ANSI/ASQ Standards:
dance with internationally recognized principles on standard- ANSI/ASQ Z1.4 Sampling Procedures and Tables for In-
ization established in the Decision on Principles for the spection by Attributes
Development of International Standards, Guides and Recom- ANSI/ASQ Z1.9 Sampling Procedures and Tables for In-
mendations issued by the Wo
...
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: F2407/F2407M − 23 F2407/F2407M − 23a
Standard Specification for
1
Surgical Gowns Intended for Use in Healthcare Facilities
This standard is issued under the fixed designation F2407/F2407M; 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.
INTRODUCTION
Healthcare workers can be exposed to biological fluids capable of transmitting diseases. These
diseases, which may be caused by a variety of microorganisms, can pose significant risks to life and
health. This is especially true of blood-borne pathogens, such as Hepatitis (Hepatitis B Virus (HBV)
and Hepatitis C Virus (HCV)) and Human Immunodeficiency Virus (HIV). Since engineering controls
cannot eliminate all possible exposures, attention is placed on reducing the potential of direct skin
contact with microorganisms, body fluids, and other potentially infectious materials through the use
of protective apparel.
Healthcare protective clothing, including surgical gowns, is worn by healthcare workers to protect
both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and other
contaminants from one person to another.
This specification addresses the performance of surgical gowns designed to preserve the sterile field
and/or protect against exposure of healthcare workers to blood, body fluids, and other potentially
infectious materials during surgery and other healthcare procedures.
This specification establishes uniform testing and reporting requirements for surgical gown
manufacturers in order to provide information to end users that can be used in making informed
decisions in the selection and purchase of surgical gowns according to the anticipated exposures. This
information is also useful for helping end users comply with the Occupational Safety and Health
Administration’s blood-borne pathogen standard (29 CFR 1910.1030).
1. 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.
1
This specification is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.40 on Biological.
Current edition approved Feb. 1, 2023June 1, 2023. Published February 2023July 2023. Originally approved in 2006. Last previous edition approved in 20222023 as
F2407/F2407M – 22a. DOI: 10.1520/F2407_F2407M-23.23. DOI: 10.1520/F2407_F2407M-23A.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F2407/F2407M − 23a
1.3 This specification is not intended to serve as a detailed manufacturing or purchase specification, but can be referenced in
purchase specifications as the basis for selecting test requirements.
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.
1.5 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
...
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