ASTM F2407/F2407M-23a

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...

General Information

• Status: Published
• Publication Date: 31-May-2023
• ICS: 11.140 - Hospital equipment
• ICS: 13.340.10 - Protective clothing
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• Refers: ASTM E96/E96M-24 - Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
• Effective Date: 01-Mar-2024
• Refers: ASTM F1154-24 - Standard Practices for Evaluating the Comfort, Fit, Function, and Durability of Protective Ensembles, Ensemble Elements, and Other Components
• Effective Date: 01-Feb-2024
• Refers: ASTM D5587-15(2024) - Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• Effective Date: 01-Jan-2024
• Refers: ASTM E96/E96M-23 - Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
• Effective Date: 15-Nov-2023
• Refers: ASTM D1776/D1776M-20 - Standard Practice for Conditioning and Testing Textiles
• Effective Date: 01-Feb-2020
• Refers: ASTM D5587-15(2019) - Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• Effective Date: 01-Jul-2019
• Refers: ASTM F1154-18 - Standard Practices for Evaluating the Comfort, Fit, Function, and Durability of Protective Ensembles, Ensemble Elements, and Other Components
• Effective Date: 15-Jul-2018
• Refers: ASTM D1683/D1683M-17 - Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• Effective Date: 01-Mar-2017
• Refers: ASTM D1683/D1683M-17e1 - Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• Effective Date: 01-Mar-2017
• Refers: ASTM D1683/D1683M-16 - Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• Effective Date: 01-Nov-2016
• Refers: ASTM D1776/D1776M-16 - Standard Practice for Conditioning and Testing Textiles
• Effective Date: 01-Jan-2016
• Refers: ASTM D5587-15 - Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• Effective Date: 01-Jul-2015
• Refers: ASTM E96/E96M-15 - Standard Test Methods for Water Vapor Transmission of Materials
• Effective Date: 01-May-2015
• Refers: ASTM D1776/D1776M-15 - Standard Practice for Conditioning and Testing Textiles
• Effective Date: 01-Feb-2015
• Refers: ASTM E96/E96M-14 - Standard Test Methods for Water Vapor Transmission of Materials
• Effective Date: 15-Oct-2014

Overview

ASTM F2407/F2407M-23a: Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities sets minimum requirements for the performance, documentation, and labeling of surgical gowns used by healthcare professionals. The standard aims to safeguard healthcare workers and patients from the transfer of microorganisms, blood, body fluids, and other potentially infectious materials during medical and surgical procedures.

ASTM F2407/F2407M-23a references performance criteria and testing methods for barrier protection, physical properties, and general safety aspects of surgical gowns. It serves as a basis for manufacturers’ claims related to gown performance and is aligned with widely accepted regulatory and industry practices. The specification covers both single-use and multiple-use surgical gowns, but does not address all aspects needed by individual healthcare facilities for product selection.

Key Topics

• Barrier Performance: The standard requires barrier testing of critical gown zones, referencing the four barrier performance levels defined in ANSI/AAMI PB70. Level 4 gowns, suitable for high-risk exposure, demand additional testing against simulated biological fluids.
• Physical Property Requirements: Surgical gowns must meet stringent criteria including:
  • Tensile Strength
  • Tear Resistance
  • Seam Strength
• Optional Test Methods: For enhanced product evaluation and end-user decision-making, properties such as lint generation, evaporative resistance, water vapor transmission rate, and abrasion resistance may also be documented.
• General Safety Requirements: Gowns must comply with biocompatibility (non-cytotoxic, non-irritating, non-sensitizing), sterility assurance, flame spread (Class 1 normal flammability), and natural rubber latex labeling.
• Documentation & Labeling: The standard mandates comprehensive product and package labeling, traceability, manufacturer identification, barrier performance level, and-for reusable gowns-instructions and tracking for laundering and sterilization cycles.

Applications

ASTM F2407/F2407M-23a is crucial for:

• Manufacturers: Guiding the design, testing, and labeling of surgical gowns to ensure compliance and effective product claims.
• Healthcare Providers: Assisting in the evaluation, selection, and procurement of appropriate protective apparel according to anticipated exposure risks (e.g., surgery, invasive procedures).
• Regulatory Compliance: Supporting adherence to OSHA’s blood-borne pathogens standard and FDA requirements for medical devices.
• Quality Assurance: Ensuring that both single-use and reusable surgical gowns perform reliably even after laundering or sterilization as specified by the manufacturer.
• Patient and Worker Safety: Providing a key reference for maintaining sterility and minimizing cross-contamination in healthcare environments.

Related Standards

Surgical gowns designed under ASTM F2407/F2407M-23a are tested and classified in conjunction with several industry standards and regulations, including:

• ANSI/AAMI PB70: Classification of barrier performance for protective apparel and drapes
• ANSI/AAMI ST65: Processing guidelines for multiple-use surgical textiles
• ISO 10993 (Parts 5, 7, 10, and 23): Biocompatibility testing and evaluation
• ASTM F3352/F3352M: Requirements for isolation gowns
• 16 CFR 1610/1611: Flammability standards for textiles and vinyl materials
• 21 CFR 878.4040: FDA requirements for surgical apparel
• 29 CFR 1910.1030: OSHA occupational exposure to bloodborne pathogens
• AATCC 42/127: Water resistance test methods

By setting uniform criteria and referencing internationally recognized test methods, ASTM F2407/F2407M-23a plays a vital role in standardizing surgical gown performance, promoting safety, and enhancing infection control in healthcare settings. This standard ensures that healthcare facilities and manufacturers have a clear, practical benchmark for quality, safety, and effectiveness in protective medical apparel.

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: F2407/F2407M − 23a
Standard Specification for
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.
1.5 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
F2407/F2407M − 23a
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 World Trade Organization Technical spection by Variables for Percent Nonconforming
Barriers to Trade (TBT) Committee.
2.5 ISO Standards:
ISO 2859-1 Sampling Plans for Inspection by Attributes
2. Referenced Documents
ISO 3951 Sampling Procedures and Charts for Inspection by
2.1 ASTM Standards:
Variables for Percent Nonconforming
D751 Test Methods for Coated Fabrics
ISO 9001 Quality Management Systems—Requirements
D1683/D1683M Test Method for Failure in Sewn Seams of
ISO 9073-10 Textiles—Test Methods for Nonwovens—Part
Woven Fabrics
10: Lint and Other Particles Generation in the Dry State
D1776/D1776M Practice for Conditioning and Testing Tex-
ISO 10993-5 Biological Evaluation of Medical Devices—
tiles
Part 5: Tests for in Vitro Cytotoxicity
D4966 Test Method for Abrasion Resistance of Textile
ISO 10993-7 Biological Evaluation of Medical Devices—
Fabrics (Martindale Abrasion Tester Method)
Part 7: Ethylene Oxide Sterilization Residuals
D5034 Test Method for Breaking Strength and Elongation of
ISO 10993-10 Biological Evaluation of Medical Devices—
Textile Fabrics (Grab Test)
Part 10: Tests for Skin Sensitization
D5587 Test Method for Tearing Strength of Fabrics by
ISO 10993-23 Biological Evaluation of Medical Devices—
Trapezoid Procedure
Part 23: Tests for Irritation
D6701 Test Method for Determining Water Vapor Transmis-
ISO 11134 Sterilization of Healthcare Products—
sion Rates Through Nonwoven and Plastic Barriers
Requirements for Validation and Routine Control—
E96/E96M Test Methods for Gravimetric Determination of
Industrial Moist Heat Sterilization
Water Vapor Transmission Rate of Materials
ISO 11135 Medical Devices—Validation and Routine Con-
F1154 Practices for Evaluating the Comfort, Fit, Function,
trol of Ethylene Oxide Sterilization
and Durability of Protective Ensembles, Ensemble
ISO 11137 Sterilization of Healthcare Products—
Elements, and Other Components
Requirements for Validation and Routine Control—
F1494 Terminology Relating to Protective Clothing
Radiation Sterilization
F1868 Test Method for Thermal Resistance, Evaporative
ANSI/AAMI/ISO 13485 Medical Devices—Quality Man-
Resistance, and Total Heat Loss Measurements of Cloth-
agement Systems—Requirements for Regulatory Pur-
ing Materials Using a Sweating Hot Plate
poses
F3050 Guide for Conformity Assessment of Personal Pro-
ISO 13683 Sterilization of Healthcare Products—
tective Clothing and Equipment
Requirements for Validation and Routine Control of Moist
F3352/F3352M Specification for Isolation Gowns Intended
Heat Sterilization in Healthcare Facilities
for Use in Healthcare Facilities
ISO/IEC 17025 General Requirements for the Competence
of Testing and Calibration Laboratories
2.2 AAMI Documents:
ISO/IEC 17026 Conformity Assessment—Example of a
ANSI/AAMI PB70 Liquid Barrier Performance and Classi-
Certification Scheme for Tangible Products
fication of Protective Apparel and Drapes Intended for
Use in Healthcare Facilities
2.6 Federal Standards:
ANSI/AAMI ST65 Processing of Multiple-Use Surgical
16 CFR 1610 Standard for the Flammability of Clothing
Textiles for Use in Healthcare Facilities
Textiles, Federal Register, Vol 40, No. 59891, Dec. 30,
AAMI TIR11 Selection of Surgical Gowns and Drapes in
Healthcare Facilities
16 CFR 1611 Standard for the Flammability of Vinyl Plastic
ANSI/AAMI BE78 Biological Evaluation of Medical
Film, Federal Register, Vol 40, No. 59891, Dec. 30, 1975
Devices, Part 10: Test for Irritation and Sensitization
21 CFR 801.437 User Labeling for Devices That Contain
4 9
2.3 AATCC Standards: Natural Rubber
AATCC 42 Water Penetration Resistance: Impact Penetra- 21 CFR 820 Subpart K Labeling and Packaging Control,
tion Test
AATCC 127 Water Resistance: Hydrostatic Pressure Test
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036.
2 6
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available from International Organization for Standardization (ISO), ISO
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Standards volume information, refer to the standard’s Document Summary page on Geneva, Switzerland, http://www.iso.org.
the ASTM website. Available at https://www.ecfr.gov/current/title-16/chapter-II/subchapter-D/part-
Available from the Association for the Advancement of Medical 1610.
Instrumentation, 110 North Glebe Road, Suite 220, Arlington, VA 22201. Available at https://www.ecfr.gov/current/title-16/chapter-II/subchapter-D/part-
Available from American Association of Textile Chemists and Colorists 1611.
(AATCC), One Davis Dr., P.O. Box 12215, Research Triangle Park, NC 27709- Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
2215. CFRSearch.cfm?fr=801.437.
F2407/F2407M − 23a
Federal Register, Vol 8, April 1, 2019 3.1.7 multiple-use, adj—refers to an item of protective
21 CFR 878.4040 Surgical Apparel, Federal Register, Vol clothing that is intended to be used several times with
63, No. 318, Nov. 12, 1998, No. 63247 appropriate care of the protective clothing item between use.
29 CFR 1910.1030 Occupational Exposure to Blood-Borne 3.1.7.1 Discussion—In this specification, multiple-use pro-
Pathogens: Final Rule, Federal Register, Vol 66, No. 12, tective clothing is subject to cleaning (laundering) and steril-
Jan. 18, 2001 ization between each use.
Food and Drug Administration UDI FDA Final Rule from
3.1.8 other potentially infectious materials, n—any
Federal Register
materials, other than blood or body fluids, containing blood-
2.7 INDA Standard:
borne pathogens or materials that have been linked with the
WSP 70.4 Water Vapor Transmission Rate—Mocon Method
potential transmission of infectious disease.
3.1.9 protective clothing, n—an item of clothing that is
3. Terminology
specifically designed and constructed for the intended purpose
3.1 Definitions:
of isolating all or part of the body from a potential hazard; or
3.1.1 blood-borne pathogen, n—an infectious bacterium or
isolating the external environment from contamination by the
virus, or other disease-inducing microbe carried in blood or
wearer of the clothing.
other potentially infectious body fluids.
3.1.9.1 Discussion—Examples of protective clothing in-
3.1.1.1 Discussion—For the purpose of this test method, the
clude surgical gowns, isolation gowns, decontamination
primary blood-borne pathogens include Hepatitis B Virus
garments, aprons, sleeve protectors, and certain types of
(HBV), Hepatitis C Virus (HCV), and Human Immunodefi-
laboratory coats. The primary purpose of the protective cloth-
ciency Virus (HIV). Other microorganisms must be considered
ing is to act as a barrier between the wearer and a hazard.
on a case-by-case basis.
However, the product may also offer protection as a barrier,
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
which prevents the body from being a source of contamination.
creted by the human body.
3.1.10 single-use, adj—refers to an item of protective cloth-
3.1.2.1 Discussion—In this specification, body fluids in-
ing that is intended to be used once and then disposed.
clude liquids potentially infected with blood-borne pathogens,
3.1.10.1 Discussion—In this specification, single-use pro-
including, but not limited to: blood, semen, vaginal secretions,
tective clothing is subject to sterilization prior to use per the
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
manufacturer’s instructions.
otic fluid, saliva in dental procedures, any body fluid that is
3.1.11 surgical gown, n—protective clothing that is intended
visibly contaminated with blood, and all body fluids in situa-
to be worn by operating room personnel during surgical
tions where it is difficult or impossible to differentiate between
procedures to protect both the surgical patient and the operat-
body fluids (see 29 CFR Part 1910.1030).
ing room personnel from the transfer of microorganisms, body
3.1.3 critical zone(s), n—area of a gown where direct
fluids, and particulate matter.
contact with blood, body fluids, and other potentially infectious
3.1.11.1 Discussion—This definition is consistent with the
materials is most likely to occur.
definition provided by the U.S. Food and Drug Administration
3.1.3.1 Discussion—Annex B of ANSI/AAMI PB70 pro-
(21 CFR 878.4040) except that the word “device” is used
vides examples of barrier classification for surgical gowns
instead of protective clothing. However, while historically
based on the critical zone(s). The critical zone can encompass
surgery happens in the operating room, currently, invasive
multiple parts of the garment.
procedures are also performed in procedure rooms and in
3.1.4 critical zone component, n—any element, constituent,
certain situations (for example, patient cannot be moved) at the
or item incorporated into the critical zone, including the
bedside. Therefore, surgical gowns are worn by personnel
materials, seams, and attachments.
during these procedures to protect both the patient and person-
3.1.4.1 Discussion—Seams at the boundary between the
nel from the transfer of microorganisms, body fluids, and
critical and noncritical zones are not considered parts of the
particulate matter.
critical zone(s).
3.2 For definitions of other protective clothing-related terms
3.1.5 flammability, n—those characteristics of a material
used in this specification, refer to Terminology F1494.
that pertain to its ignition and support of combustion.
3.1.6 healthcare protective clothing, n—protective clothing
4. Significance and Use
used in a healthcare setting.
4.1 This specification provides minimum requirements for
surgical gowns used for protection of healthcare workers where
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
the potential for exposure to blood, body fluids, and other
CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.11.
potentially infectious materials exists. The specification re-
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/
quires barrier testing based on the system of classifying gowns
CFRSearch.cfm?FR=878.4040.
established in ANSI/AAMI PB70 and sets general safety re-
Available at https://www.osha.gov/laws-regs/regulations/standardnumber/
1910/1910.1030.
quirements for surgical gowns based on biocompatibility,
Available at https://www.federalregister.gov/documents/2013/09/24/2013-
sterility assurance, and flame spread. Performance require-
23059/unique-device-identification-system.
ments are established for important physical properties, includ-
Available from Association of the Nonwoven Fabrics Industry (INDA), 1100
Crescent Green, Suite 115, Cary, NC 27518, http://www.inda.org. ing tensile strength, tear strength, and seam strength. Methods
F2407/F2407M − 23a
to be used for optional reporting of performance of linting gown that a processor could use to employ their own means for
resistance, evaporative resistance, water vapor transmission recording or marking the number of laundering and steriliza-
rate, and abrasion resistance are provided. tion cycles. The recording area shall be visible/readable by the
wearer.
4.2 This specification does not address protective clothing
5.3 The sizes of the critical zone(s) of a surgical gown shall
used for nonsurgical applications, such as isolation gowns or
decontamination gowns; protective clothing for the hands, such be defined by anatomical reference in accordance with ANSI/
AAMI PB70.
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; 6. General Safety and Performance Requirements
protective clothing for the feet, such as operating room shoes,
6.1 Biocompatibility:
shoe covers, or surgical boots; or other types of protective
6.1.1 Materials used in the construction of surgical gowns
clothing and equipment worn by healthcare providers.
shall be classified as external devices that contact breached or
4.3 Surgical gowns are either multiple-use or single-use compromised surfaces for limited exposures and shall pass the
products as designated by the manufacturer. This specification appropriate evaluations in accordance with ANSI/
is intended to provide the basis for manufacturer claims for AAMI BE78. Alternatively, ISO 10993-5, ISO 10993-10, and
surgical gown performance and efficacy. For multiple-use ISO 10993-23 are permitted to be used. Assessment shall be
gowns, this specification takes into account the anticipated care conducted to ensure the safety of the device. Materials used in
and maintenance of these products by examining test require- the construction of surgical gowns shall be non-sensitizing,
ments for surgical gown materials both before and after the non-irritating, and non-cytotoxic.
maximum expected number of cycles for laundering and
NOTE 3—The entire gown is considered body contacting. For the
sterilization.
purposes of evaluating gown biocompatibility, all materials and colors
used in the construction of surgical gowns should be part of the test
4.4 Additional information on the processing of multiple-
samples. These materials should include all different materials and
use surgical gowns is provided in ANSI/AAMI ST65.
components used in the gown, including the thread and elastic, seam
binding, or knit cuffs, if used in the gown’s construction.
4.5 While surgical gowns are classified for barrier perfor-
NOTE 4—FDA categorizes the final, finished surgical gown as surface-
mance as specified in ANSI/AAMI PB70, this specification
contacting devices that contact breached or compromised surfaces for
establishes other design criteria, minimum physical perfor-
short-term exposure and therefore the surgical gown shall pass the
mance criteria, labeling, and documentation requirements for
appropriate evaluations in accordance with ISO 10993, if supplied in the
USA. Common test methods used for the assessment of the
surgical gowns and their materials.
biocompatibility, including cytotoxicity, skin sensitization, and irritation,
4.5.1 In addition to the barrier performance of the surgical
are ISO 10993-5, ISO 10993-10, and ISO 10993-23.
gown material and seams, surgical gown material and seams
NOTE 5—If a surgical gown includes drugs, biologics, nanomaterials, or
are also required to meet minimum requirements for tensile
antimicrobial/antiviral agents, additional testing or information (for
strength, tear strength, and seam strength that have been
example, chemical characterization) associated with a toxicological risk
established on the basis of an analysis of workplace require- assessment may be warranted.
NOTE 6—The common test methods for biocompatibility of finished
ments. Surgical gowns with different barrier level claims shall
surgical gowns are in vitro cytotoxicity (for example, MEM elution),
meet the same minimum strength requirements regardless of
irritation, and skin sensitization.
their barrier level.
NOTE 7—If the surgical gown is sterilized by ethylene oxide steriliza-
4.5.2 Additional properties for surgical gown material such tion method, then the residual ethylene oxide and ethylene chlorohydrin
shall be within the maximum allowable limits specified in ISO 10993-7 or
as lint generation, evaporative resistance or water vapor
the surgical gown shall exhibit negligible irritation as specified in ISO
transmission rate, and durability are optional for testing for the
10993-23.
purpose of documenting performance. No minimum criteria
6.2 Sterility Assurance Level:
are established for these properties, but purchasers may use this
6.2.1 The selected sterilization process for surgical gowns
information to compare products.
shall have a sterility assurance level of at least 10-6.
4.5.3 Surgical gowns differ from isolation gowns based on
6.2.2 If the surgical gown is sterilized by ethylene oxide
their intended use and anticipated location of liquid contact.
sterilization method, the residual ethylene oxide and ethylene
Specific requirements for isolation gowns beyond the barrier
chlorohydrin shall be within the maximum allowable limits
performance of isolation gown materials and seams are pro-
specified in ISO 10993-7 or the surgical gown shall exhibit
vided in Specification F3352/F3352M.
negligible irritation as specified in ISO 10993-23.
4.6 Additional information for the testing, selection, and use
NOTE 8—Appropriate sterilization processes include those specified in
of surgical gowns is provided in AAMI TIR11.
ISO 11134 for moist heat, ISO 11135 for EtO, ISO 11137 for Gamma, or
ISO 13683 also for moist heat.
5. Design Requirements
6.3 Flame Spread:
5.1 Surgical gowns shall be designed to comply with the
6.3.1 Materials used in the construction of surgical gowns
barrier performance requirements of ANSI/AAMI PB70.
shall meet the requirements for Class 1 “normal flammability”
5.2 Surgical gowns which are intended for reuse shall have in accordance with 16 CFR Part 1610 (or 16 CFR 1611 if the
either a means for recording or marking the number of material is vinyl) before and after the conditioning specified in
processing cycles, or have an area (or multiple areas) on the Section 9.
F2407/F2407M − 23a
6.4 Natural Rubber Latex: acceptance level (Alpha = 0.05) with the maximum RQL set at
6.4.1 Gowns that contain natural rubber latex should be 20 % at a 10 % acceptance level (Beta = 0.10). For an original
clearly labeled and include the latex caution statement per CFR classification of a product, the sampling plan shall be applied
801.437, “THIS PRODUCT CONTAINS NATURAL RUB- independently to each material or component, or both, and the
BER LATEX WHICH MAY CAUSE ALLERGIC REAC- finished product across multiple lots (minimum three noncon-
TION.” (See 11.2.13 for labeling requirements.) secutive lots with a minimum sample size of 32 per lot).
8.2.1 Examples of acceptable sampling plans for the other
7. Barrier and Physical Property Requirements
physical properties are found in references such as ANSI/
ASQ Z1.4 and Z1.9, ISO 2859-1, and ISO 3951.
7.1 The barrier performance of single and multiple-use
surgical gowns shall be tested and reported as specified in
8.3 Material, seam, and point of attachment specimens shall
ANSI/AAMI PB70-2012.
be removed from manufactured surgical gowns and condi-
7.2 The physical property performance of single and tioned in accordance with Section 9, and shall be representative
multiple-use surgical gowns shall be tested and reported as of the actual finished gowns.
specified in Table 1. Multiple-use surgical gowns shall meet
8.3.1 If different types of seams are used in the construction
these minimum requirements after one washing/drying and of a gown, each type of seam shall be separately tested.
sterilization cycle, and after the maximum number of cycles of
8.3.2 If the seam/point of attachment is located close to the
washing/drying and sterilization processing specified by the
edge (less than 2 in. to the edge), the barrier resistance testing
manufacturer.
is not required on those areas.
NOTE 9—Tensile and tear strength requirements apply to both machine
9. Conditioning
(MD) and cross-machine (CD) direction of material. The seam strength is
tested perpendicular to the seam and shall be tested in locations where the
9.1 General Requirements—Testing used for demonstrating
material orientations are different.
performance of surgical gowns shall be conducted after ambi-
7.3 Additional performance properties that can be option-
ent conditioning on both single and multiple-use products as
ally reported are listed in Table 2.
specified in 9.2. For surgical gowns where the manufacturer is
NOTE 10—Refer to Section 10 and Appendix X1 for more information claiming continued barrier performance after multiple uses, or
and conditions about Table 1 and Table 2 test methods.
if laundering/sterilization is required before use, then testing
shall also be conducted after the maximum number of cycles of
8. Sampling
washing/drying (9.3) and sterilization (9.4) specified by the
8.1 Sample size for the physical property requirements shall
manufacturer using samples taken from the same lots.
be determined as follows for each lot. For tensile strength, take
9.2 Ambient Conditioning—All specimens shall be condi-
five samples from the machine direction and eight samples
tioned at a temperature of 21 6 3 °C [70 6 5 °F] and relative
from the cross-machine direction for each test condition
humidity of 65 6 5 % for at least 24 h in accordance with
described in 9.1 – 9.4, as applicable to a material specification.
Practice D1776/D1776M, unless otherwise specified by the
For tear strength, take five samples from the machine direction
selected test method.
and five samples from the cross-machine direction for each test
9.3 Laundering Conditioning—Specimens from multiple-
condition described in 9.1 – 9.4, as applicable to a material
use surgical gowns shall be laundered using the manufacturer’s
specification. For seam strength, take five test samples for each
recommended washing and drying procedures. These proce-
specified seam assembly used in the surgical gown for each test
dures shall conform to ANSI/AAMI ST65. The total number of
condition described in 9.1 – 9.4, as applicable to a material
washing and drying cycles specified in the manufacturer’s
specification. In these test methods, each sample shall be taken
claims shall be used.
from a different garment and minimum three nonconsecutive
lots.
9.4 Sterilization—If specimens are not removed from sterile
8.2 Sample size for the barrier requirements shall be suffi- surgical gowns, specimens from surgical gowns shall be
cient to establish an acceptable statistical confidence interval sterilized using the manufacturer’s recommended sterilization
for the property being measured. Test specimens shall be
process and specific sterilization cycle parameters (for
selected randomly according to a statistical sampling plan that example, time, temperature, sterilant concentration, humidity,
is appropriate for the type of data being generated. For etc.). Sterilization of specimen surgical gowns shall be per-
examples of suitable sampling plans specific to barrier perfor- formed following each laundering cycle as specified in 9.3 for
mance properties, see ANSI/AAMI PB70, Annex C. In this multiple-use surgical gowns. The total number of sterilization
document, the maximum AQL is set at 4.0 % at a 95 % cycles specified in the manufacturer’s claims shall be followed.
TABLE 1 Physical Property Performance Requirements of Single and Multiple-Use Surgical Gowns
ANSI/AAMI PB70 Level
Property Material Type Test Method
All Barrier Levels (1, 2, 3, and 4)
Tensile strength All ASTM D5034 $30 N [$7 lbf]
Tear strength All ASTM D5587 $10 N [$2.3 lbf]
Seam strength All ASTM D1683/D1683M $30 N [$7 lbf]
F2407/F2407M − 23a
A
TABLE 2 Optional Tests Documentation Requirements (Documentation Only)
Performance Property Test Method Subsection Reported Data
B
Lint generation ISO 9073, Part 10 10.3.1 Particle count for each side, unless material is
the same on each side
C
Evaporative resistance or ASTM F1868 10.3.2 Average evaporative resistance
C
Water vapor transmission rate or ASTM D6701 10.3.3 Average water vapor transmission rate
C
Water vapor transmission rate (Mocon method) WSP 70.4 10.3.3 Average water vapor transmission rate
C
Water vapor transmission rate ASTM E96/E96M 10.3.3 Average permeance
Abrasion resistance (Martindale) ASTM D4966 10.3.4 Average abrasion resistance
A
Appendix X1 provides a description of each method, its intended application, and limitations.
B
Results from lint testing are highly operator and equipment dependent. It is recommended that data be collected using
...

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
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.
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
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 and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
D751 Test Methods for Coated Fabrics
D1683/D1683M Test Method for Failure in Sewn Seams of Woven Fabrics
D1776/D1776M Practice for Conditioning and Testing Textiles
D4966 Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method)
D5034 Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
D5587 Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
D5733 Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Withdrawn 2008)
D6701 Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
E96/E96M Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
F1154 Practices for Evaluating the Comfort, Fit, Function, and Durability of Protective Ensembles, Ensemble Elements, and
Other Components
F1494 Terminology Relating to Protective Clothing
F1868 Test Method for Thermal Resistance, Evaporative Resistance, and Total Heat Loss Measurements of Clothing Materials
Using a Sweating Hot Plate
F3050 Guide for Conformity Assessment of Personal Protective Clothing and Equipment
F3352/F3352M Specification for Isolation Gowns Intended for Use in Healthcare Facilities
2.2 AAMI Documents:
ANSI/AAMI PB70 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in
Healthcare Facilities
ANSI/AAMI ST65 Processing of Multiple-Use Surgical Textiles for Use in Healthcare Facilities
AAMI TIR11 Selection of Surgical Gowns and Drapes in Healthcare Facilities
ANSI/AAMI BE78 Biological Evaluation of Medical Devices, Part 10: Test for Irritation and Sensitization
2.3 AATCC Standards:
AATCC 42 Water Penetration Resistance: Impact Penetration Test
AATCC 127 Water Resistance: Hydrostatic Pressure Test
2.4 ANSI/ASQ Standards:
ANSI/ASQ Z1.4 Sampling Procedures and Tables for Inspection by Attributes
ANSI/ASQ Z1.9 Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
2.5 ISO Standards:
ISO 2859-1 Sampling Plans for Inspection by Attributes
ISO 3951 Sampling Procedures and Charts for Inspection by Variables for Percent Nonconforming
ISO 9001 Quality Management Systems—Requirements
ISO 9073-10 Textiles—Test Methods for Nonwovens—Part 10: Lint and Other Particles Generation in the Dry State
ISO 10993-5 Biological Evaluation of Medical Devices—Part 5: Tests for in Vitro Cytotoxicity
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 the Association for the Advancement of Medical Instrumentation, 110 North Glebe Road, Suite 220, Arlington, VA 22201.
Available from American Association of Textile Chemists and Colorists (AATCC), One Davis Dr., P.O. Box 12215, Research Triangle Park, NC 27709-2215.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
Available from International Organization for Standardization (ISO), ISO Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
Switzerland, http://www.iso.org.
F2407/F2407M − 23a
ISO 10993-7 Biological Evaluation of Medical Devices—Part 7: Ethylene Oxide Sterilization Residuals
ISO 10993-10 Biological Evaluation of Medical Devices—Part 10: Tests for Skin Sensitization
ISO 10993-23 Biological Evaluation of Medical Devices—Part 23: Tests for Irritation
ISO 11134 Sterilization of Healthcare Products—Requirements for Validation and Routine Control—Industrial Moist Heat
Sterilization
ISO 11135 Medical Devices—Validation and Routine Control of Ethylene Oxide Sterilization
ISO 11137 Sterilization of Healthcare Products—Requirements for Validation and Routine Control—Radiation Sterilization
ANSI/AAMI/ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
ISO 13683 Sterilization of Healthcare Products—Requirements for Validation and Routine Control of Moist Heat Sterilization
in Healthcare Facilities
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
2.6 Federal Standards:
16 CFR 1610 Standard for the Flammability of Clothing Textiles, Federal Register, Vol 40, No. 59891, Dec. 30, 1975
16 CFR 1611 Standard for the Flammability of Vinyl Plastic Film, Federal Register, Vol 40, No. 59891, Dec. 30, 1975
21 CFR 801.437 User Labeling for Devices That Contain Natural Rubber
21 CFR 820 Subpart K Labeling and Packaging Control, Federal Register, Vol 8, April 1, 2019
21 CFR 878.4040 Surgical Apparel, Federal Register, Vol 63, No. 318, Nov. 12, 1998, No. 63247
29 CFR 1910.1030 Occupational Exposure to Blood-Borne Pathogens: Final Rule, Federal Register, Vol 66, No. 12, Jan. 18,
Food and Drug Administration UDI FDA Final Rule from Federal Register
2.7 INDA Standard:
WSP 70.4 Water Vapor Transmission Rate—Mocon Method
3. Terminology
3.1 Definitions:
3.1.1 blood-borne pathogen, n—an infectious bacterium or virus, or other disease-inducing microbe carried in blood or other
potentially infectious body fluids.
3.1.1.1 Discussion—
For the purpose of this test method, the primary blood-borne pathogens include Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
and Human Immunodeficiency Virus (HIV). Other microorganisms must be considered on a case-by-case basis.
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 critical zone(s), n—area of a gown where direct contact with blood, body fluids, and other potentially infectious materials
is most likely to occur.
3.1.3.1 Discussion—
Annex B of ANSI/AAMI PB70 provides examples of barrier classification for surgical gowns based on the critical zone(s). The
critical zone can encompass multiple parts of the garment.
3.1.4 critical zone component, n—any element, constituent, or item incorporated into the critical zone, including the materials,
seams, and attachments.
3.1.4.1 Discussion—
Seams at the boundary between the critical and noncritical zones are not considered parts of the critical zone(s).
Available at https://www.ecfr.gov/current/title-16/chapter-II/subchapter-D/part-1610.
Available at https://www.ecfr.gov/current/title-16/chapter-II/subchapter-D/part-1611.
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=801.437.
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1&subpartNode=21:8.0.1.1.12.11.
Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=878.4040.
Available at https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030.
Available at https://www.federalregister.gov/documents/2013/09/24/2013-23059/unique-device-identification-system.
Available from Association of the Nonwoven Fabrics Industry (INDA), 1100 Crescent Green, Suite 115, Cary, NC 27518, http://www.inda.org.
F2407/F2407M − 23a
3.1.5 flammability, n—those characteristics of a material that pertain to its ignition and support of combustion.
3.1.6 healthcare protective clothing, n—protective clothing used in a healthcare setting.
3.1.7 multiple-use, adj—refers to an item of protective clothing that is intended to be used several times with appropriate care of
the protective clothing item between use.
3.1.7.1 Discussion—
In this specification, multiple-use protective clothing is subject to cleaning (laundering) and sterilization between each use.
3.1.8 other potentially infectious materials, n—any materials, other than blood or body fluids, containing bloodborne pathogens
or materials that have been linked with the potential transmission of infectious disease.
3.1.9 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.
3.1.9.1 Discussion—
Examples of protective clothing include surgical gowns, isolation gowns, decontamination garments, aprons, sleeve protectors, and
certain types of laboratory coats. The primary purpose of the protective clothing is to act as a barrier between the wearer and a
hazard. However, the product may also offer protection as a barrier, which prevents the body from being a source of contamination.
3.1.10 single-use, adj—refers to an item of protective clothing that is intended to be used once and then disposed.
3.1.10.1 Discussion—
In this specification, single-use protective clothing is subject to sterilization prior to use per the manufacturer’s instructions.
3.1.11 surgical gown, n—protective clothing that is intended to be worn by operating room personnel during surgical procedures
to protect both the surgical patient and the operating room personnel from the transfer of microorganisms, body fluids, and
particulate matter.
3.1.11.1 Discussion—
This definition is consistent with the definition provided by the U.S. Food and Drug Administration (21 CFR 878.4040) except that
the word “device” is used instead of protective clothing. However, while historically surgery happens in the operating room,
currently, invasive procedures are also performed in procedure rooms and in certain situations (for example, patient cannot be
moved) at the bedside. Therefore, surgical gowns are worn by personnel during these procedures to protect both the patient and
personnel from the transfer of microorganisms, body fluids, and particulate matter.
3.2 For definitions of other protective clothing-related terms used in this specification, refer to Terminology F1494.
4. 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.
F2407/F2407M − 23a
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 as specified in ANSI/AAMI PB70, this specification establishes
other design criteria, minimum physical performance criteria, labeling, and documentation requirements for surgical gowns and
their materials.
4.5.1 In addition to the barrier performance of the surgical gown material and seams, surgical gown material and seams are also
required to meet minimum requirements for tensile strength, tear strength, and seam strength that have been established on the
basis of an analysis of workplace requirements. Surgical gowns with different barrier level claims shall meet the same minimum
strength requirements regardless of their barrier level.
4.5.2 Additional properties for surgical gown material such as lint generation, evaporative resistance or water vapor transmission
rate, and durability are optional for testing for the purpose of documenting performance. No minimum criteria are established for
these properties, but purchasers may use this information to compare products.
4.5.3 Surgical gowns differ from isolation gowns based on their intended use and anticipated location of liquid contact. Specific
requirements for isolation gowns beyond the barrier performance of isolation gown materials and seams are provided in
Specification F3352/F3352M.
4.6 Additional information for the testing, selection, and use of surgical gowns is provided in AAMI TIR11.
5. Design Requirements
5.1 Surgical gowns shall be designed to comply with the barrier performance requirements of ANSI/AAMI PB70.
5.2 Surgical gowns which are intended for reuse shall have either a means for recording or marking the number of processing
cycles, or have an area (or multiple areas) on the gown that a processor could use to employ their own means for recording or
marking the number of laundering and sterilization cycles. The recording area shall be visible/readable by the wearer.
5.3 The sizes of the critical zone(s) of a surgical gown shall be defined by anatomical reference in accordance with
ANSI/AAMI PB70.
6. General Safety and Performance Requirements
6.1 Biocompatibility:
6.1.1 Materials used in the construction of surgical gowns shall be classified as external devices that contact breached or
compromised surfaces for limited exposures and shall pass the appropriate evaluations in accordance with ANSI/AAMI BE78.
Alternatively, ISO 10993-5, ISO 10993-10, and ISO 10993-23 are permitted to be used. Assessment shall be conducted to ensure
the safety of the device. Materials used in the construction of surgical gowns shall be non-sensitizing, non-irritating, and
non-cytotoxic.
NOTE 3—The entire gown is considered body contacting. For the purposes of evaluating gown biocompatibility, all materials and colors used in the
construction of surgical gowns should be part of the test samples. These materials should include all different materials and components used in the gown,
including the thread and elastic, seam binding, or knit cuffs, if used in the gown’s construction.
NOTE 4—FDA categorizes the final, finished surgical gown as surface-contacting devices that contact breached or compromised surfaces for short-term
exposure and therefore the surgical gown shall pass the appropriate evaluations in accordance with ISO 10993, if supplied in the USA. Common test
methods used for the assessment of the biocompatibility, including cytotoxicity, skin sensitization, and irritation, are ISO 10993-5, ISO 10993-10, and
ISO 10993-23.
NOTE 5—If a surgical gown includes drugs, biologics, nanomaterials, or antimicrobial/antiviral agents, additional testing or information (for example,
chemical characterization) associated with a toxicological risk assessment may be warranted.
NOTE 6—The common test methods for biocompatibility of finished surgical gowns are in vitro cytotoxicity (for example, MEM elution), irritation, and
skin sensitization.
NOTE 7—If the surgical gown is sterilized by ethylene oxide sterilization method, then the residual ethylene oxide and ethylene chlorohydrin shall be
F2407/F2407M − 23a
within the maximum allowable limits specified in ISO 10993-7 or the surgical gown shall exhibit negligible irritation as specified in ISO 10993-23.
6.2 Sterility Assurance Level:
6.2.1 The selected sterilization process for surgical gowns shall have a sterility assurance level of at least 10-6.
6.2.2 If the surgical gown is sterilized by ethylene oxide sterilization method, the residual ethylene oxide and ethylene
chlorohydrin shall be within the maximum allowable limits specified in ISO 10993-7 or the surgical gown shall exhibit negligible
irritation as specified in ISO 10993-23.
NOTE 8—Appropriate sterilization processes include those specified in ISO 11134 for moist heat, ISO 11135 for EtO, ISO 11137 for Gamma, or
ISO 13683 also for moist heat.
6.3 Flame Spread:
6.3.1 Materials used in the construction of surgical gowns shall meet the requirements for Class 1 “normal flammability” in
accordance with 16 CFR Part 1610 (or 16 CFR 1611 if the material is vinyl) before and after the conditioning specified in Section
9.
6.4 Natural Rubber Latex:
6.4.1 Gowns that contain natural rubber latex should be clearly labeled and include the latex caution statement per CFR 801.437,
“THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION.” (See 11.2.13
for labeling requirements.)
7. Barrier and Physical Property Requirements
7.1 The barrier performance of single and multiple-use surgical gowns shall be tested and reported as specified in ANSI/AAMI
PB70-2012.
7.2 The physical property performance of single and multiple-use surgical gowns shall be tested and reported as specified in Table
1. Multiple-use surgical gowns shall meet these minimum requirements after one washing/drying and sterilization cycle, and after
the maximum number of cycles of washing/drying and sterilization processing specified by the manufacturer.
NOTE 9—Tensile and tear strength requirements apply to both machine (MD) and cross-machine (CD) direction of material. The seam strength is tested
perpendicular to the seam and shall be tested in locations where the material orientations are different.
7.3 Additional performance properties that can be optionally reported are listed in Table 2.
NOTE 10—Refer to Section 10 and Appendix X1 for more information and conditions about Table 1 and Table 2 test methods.
8. Sampling
8.1 Sample size for the physical property requirements shall be determined as follows for each lot. For tensile strength, take five
samples from the machine direction and eight samples from the cross-machine direction for each test condition described in 9.1
– 9.4, as applicable to a material specification. For tear strength, take five samples from the machine direction and five samples
from the cross-machine direction for each test condition described in 9.1 – 9.4, as applicable to a material specification. For seam
TABLE 1 Physical Property Performance Requirements of Single and Multiple-Use Surgical Gowns
ANSI/AAMI PB70 Level
Property Material Type Test Method
All Barrier Levels (1, 2, 3, and 4)
Tensile strength All ASTM D5034 $30 N [$7 lbf]
Tear strength All ASTM D5587 or D5733 $10 N [$2.3 lbf]
Tear strength All ASTM D5587 $10 N [$2.3 lbf]
Seam strength All ASTM D1683/D1683M $30 N [$7 lbf]
F2407/F2407M − 23a
A
TABLE 2 Optional Tests Documentation Requirements (Documentation Only)
Performance Property Test Method Subsection Reported Data
B
Lint generation ISO 9073, Part 10 10.3.1 Particle count for each side, unless material is
the same on each side
C
Evaporative resistance or ASTM F1868 10.3.2 Average evaporative resistance
C
Water vapor transmission rate or ASTM D6701 10.3.3 Average water vapor transmission rate
C
Water vapor transmission rate (Mocon method) WSP 70.4 10.3.3 Average water vapor transmission rate
C
Water vapor transmission rate ASTM E96/E96M 10.3.3 Average permeance
Abrasion resistance (Martindale) ASTM D4966 10.3.4 Average abrasion resistance
A
Appendix X1 provides a description of each method, its intended application, and limitations.
B
Results from lint testing are highly operator and equipment dependent. It is recommended that data be collected using a single piece of equipment, using a single
operator, and on the same day to minimize variability.
C
This specification permits reporting either evaporative resistance or water vapor transmission rate using Test Method F1868 or D6701, WSP 70.4, or Test Methods
E96/E96M. Appendix X1 provides a comparison of the four methods with their respective procedures, application, specified conditions, and limitations. Garment comfort
is a function of several factors, including but not limited to: fabric “breathability,” garment design, weight, fabric stiffness, the degree of garment fit on the individual wearer,
and other possible individual wearer preferences (for example, noise, odor). Due to the complexity of these factors, the best assessment of overall gown comfort can be
made through actual wear tests. Measuring the breathability of the fabrics used to construct surgical gowns is one method of predicting thermal comfort. Those gowns that
are designed and constructed of materials which more freely allow evaporation of perspiration and body heat transfer provide better thermal comfort. When gowns are
constructed or reinforced with different materials in different zones, then testing the breathability of all the materials is important to help gain an understanding of the impact
of overall garment design on thermal comfort. Comparisons of breathability between different surgical gowns (or gown materials) should only be made using the same test
method. Also included in Appendix X1 are other potential factors that can affect comfort.
strength, take five test samples for each specified seam assembly used in the surgical gown for each test condition described in
9.1 – 9.4, as applicable to a material specification. In these test methods, each sample shall be taken from a different garment and
minimum three nonconsecutive lots.
8.2 Sample size for the barrier requirements shall be sufficient to establish an acceptable statistical confidence interval for the
property being measured. Test specimens shall be selected randomly according to a statistical sampling plan that is appropriate for
the type of data being generated. For examples of suitable sampling plans specific to barrier performance properties, see
ANSI/AAMI PB70, Annex C. In this document, the maximum AQL is set at 4.0 % at a 95 % acceptance level (Alpha = 0.05) with
the maximum RQL set at 20 % at a 10 % acceptance level (Beta = 0.10). For an original classification of a product, the sampling
plan shall be applied independently to each material or component, or both, and the finished product across multiple lots (minimum
three nonconsecutive lots with a minimum sample size of 32 per lot).
8.2.1 Examples of acceptable sampling plans for the other physical properties are found in references such as ANSI/ASQ Z1.4 and
Z1.9, ISO 2859-1, and ISO 3951.
8.3 Material, seam, and point of attachment specimens shall be removed from manufactured surgical gowns and conditioned in
accordance with Section 9, and shall be representative of the actual finished gowns.
8.3.1 If different types of seams are used in the construction of a gown, each type of seam shall be separately tested.
8.3.2 If the seam/point of attachment is located close to the edge (less than 2 in. to the edge), the barrier resistance testing is not
required on those areas.
9. Conditioning
9.1 General Requirements—Testing used for demonstrating performance of surgical gowns shall be conducted after ambient
conditioning on both single and multiple-use products as specified in 9.2. For surgical gowns where the manufacturer is claiming
continued barrier performance after multiple uses, or if laundering/sterilization is required before use, then testing shall also be
conducted after the maximum number of cycles of washing/drying (9.3) and sterilization (9.4) specified by the manufacturer using
samples taken from the same lots.
9.2 Ambient Conditioning—All specimens shall be conditioned at a temperature of 21 6 3 °C [70 6 5 °F] and relat
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