ASTM F3352/F3352M-23b

Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

SCOPE
1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.  
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns, precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by ANSI/AAMI PB70 are excluded from this standard.  
1.3 This specification does not address protective clothing used for surgical applications, such as surgical 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.  
1.4 Units—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.  
1.5 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.

General Information

• Status: Published
• Publication Date: 31-May-2023
• ICS: 11.020.99 - Other standards related to health care in general
• ICS: 11.100.99 - Other standards related to laboratory medicine
• ICS: 13.340.10 - Protective clothing
• Technical Committee: F23 - Personal Protective Clothing and Equipment
• Drafting Committee: F23.40 - Biological

Relations

• 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 F392/F392M-23 - Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability
• Effective Date: 01-Oct-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 D1776/D1776M-15 - Standard Practice for Conditioning and Testing Textiles
• Effective Date: 01-Feb-2015
• Refers: ASTM D5587-14 - Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• Effective Date: 15-Feb-2014
• Refers: ASTM F1868-14 - Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
• Effective Date: 01-Feb-2014
• Refers: ASTM F1494-13 - Standard Terminology Relating to Protective Clothing
• Effective Date: 01-Jul-2013

Overview

ASTM F3352/F3352M-23b is a standard specification developed by ASTM International for isolation gowns intended for use in healthcare facilities. This standard establishes the minimum performance, design, and labeling requirements for isolation gowns designed to protect healthcare workers, patients, and visitors from the transmission of microorganisms, blood, body fluids, and other potentially infectious materials. The specification references the four barrier performance levels outlined in ANSI/AAMI PB70, ensuring that healthcare providers can select appropriate protective apparel for different risk scenarios.

The standard applies specifically to isolation gowns as defined in ANSI/AAMI PB70 and excludes other types of healthcare gowns (such as cover gowns, surgical gowns, and decontamination gowns), as well as protective equipment for hands, head, or feet.

Key Topics

• Barrier Performance: Isolation gowns are classified according to barrier protection levels (1 to 4), referencing the ANSI/AAMI PB70 standard. This focuses on protection from fluids and pathogens.
• Design Requirements: Gowns must provide 360° coverage of the arms and torso, meeting stringent requirements for coverage, material strength, and seam integrity.
• Biocompatibility and Safety: Materials must be non-sensitizing, non-irritating, and non-cytotoxic, with requirements for labeling in the presence of natural rubber latex.
• Durability and Use: The standard differentiates between single-use and multiple-use gowns. Multiple-use gowns require specific methods for tracking the number of processing cycles.
• Physical Properties: Gowns must meet minimum criteria for tensile strength, tear resistance, and seam performance, vital for the garment’s reliability during use.
• Labeling and Documentation: Strict guidelines ensure that healthcare purchasers and users can identify barrier level, manufacturer, lot codes, use-by dates, and care instructions.

Applications

Isolation gowns specified under ASTM F3352/F3352M-23b are critical components of healthcare personal protective equipment (PPE), intended for:

• Standard Precautions: Routine patient care where exposure to blood or body fluids may occur.
• Transmission-Based Precautions: High-risk procedures with increased exposure risk to infectious agents, including care for patients with known or suspected contagious diseases.
• Infection Control: Preventing the transfer of microorganisms between patients, visitors, and healthcare workers.

The standard facilitates:

• Purchasing Decisions: Uniform testing and labeling enable healthcare facilities to make informed selections based on anticipated exposure and task.
• Safety Assurance: Gowns meeting this standard help reduce occupational exposure to bloodborne pathogens such as HBV, HCV, and HIV.
• Compliance and Traceability: Stringent labeling and documentation requirements support regulatory compliance and traceability in case of recalls or incidents.

Related Standards

The following standards are referenced or related to ASTM F3352/F3352M-23b:

• ANSI/AAMI PB70: Outlines the liquid barrier performance and classification system for protective apparel and drapes in healthcare.
• ASTM F2407/F2407M: Standard specification for surgical gowns.
• ISO 10993 Series: Biological evaluation of medical devices (biocompatibility tests).
• OSHA 29 CFR 1910.1030: Occupational exposure to blood-borne pathogens.
• AATCC 42 & 127: Standards for water resistance of textiles.
• ASTM F1671/F1671M: Resistance of materials to penetration by blood-borne pathogens.
• 16 CFR 1610/1611: Flammability standards for textile and vinyl plastic film.

Practical Value

By adhering to ASTM F3352/F3352M-23b, manufacturers, healthcare providers, and regulators can ensure consistency in protective gown performance, safeguard healthcare environments, and support efforts for infection prevention and occupational safety. The standard’s clear criteria for performance, durability, and labeling contribute to improved safety outcomes and efficiency in the selection, use, and management of isolation gowns in healthcare settings.

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: F3352/F3352M − 23b
Standard Specification for
Isolation Gowns Intended for Use in Healthcare Facilities
This standard is issued under the fixed designation F3352/F3352M; 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 personal protective equipment, including isolation gowns, is worn by healthcare workers
to protect the patient, the healthcare worker, and visitors from the transfer of microorganisms, blood
and other body fluids, and other contaminants.
Healthcare workers and patients can be exposed to body fluids and other potentially infectious
materials 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), as well as other healthcare-associated infections. Since engineering
controls cannot eliminate all possible exposures, attention is placed on reducing the potential for direct
skin contact with microorganisms, blood or other body fluids, and other potentially infectious
materials through the use of protective clothing.
The ASTM F23.40 Biological Subcommittee work group surveyed infection preventionists to
determine use/wear issues, familiarity with isolation gown performance standards, and to identify
compliance perceptions and problems. Results of this survey clearly indicated issues with the
physical performance of the isolation gowns used in healthcare settings. Development of this standard,
which includes performance and design criteria for isolation gowns, is intended to assist end users in
correct gown selection. The minimum criteria in this specification were established based on the
findings of a study in collaboration with National Institute for Occupational Safety and Health and
committee discussions.
This specification addresses the performance of isolation gowns designed to protect the healthcare
worker, the patient, and visitors from exposure to blood, body fluids, and other potentially infectious
materials during patient care or patient procedures.
This specification establishes uniform testing and reporting requirements for isolation gown
manufacturers in order to provide information to end users that can be used in making informed
decisions in the evaluation, selection, and purchase of isolation gowns according to the anticipated
exposures.
1. Scope for use by healthcare workers to provide protection for
standard and transmission-based precautions. The intended use
1.1 This specification establishes minimum requirements
of this specification is to ensure the performance properties of
for the performance and labeling of isolation gowns intended
isolation gowns for the protection of the wearer. Four levels of
barrier properties for isolation gowns are specified in ANSI/
This specification is under the jurisdiction of ASTM Committee F23 on
AAMI PB 70, and are included in this specification for
Personal Protective Clothing and Equipment and is the direct responsibility of
Subcommittee F23.40 on Biological.
reference purposes.
Current edition approved June 1, 2023. Published July 2023. Originally approved
1.2 There are other types of gowns that are used in health-
in 2019. Last previous edition approved in 2023 as F3352/F3352M – 23a. DOI:
10.1520/F3352_F3352M-23B.
care settings, including: cover gowns, procedure gowns, com-
Cloud, R., Favret, U. B., Cunningham, T., Daley, J., Harris, L. G., Kilinc-Balci,
fort gowns, precaution gowns, and open-back gowns. All
F. S., and Lewis, J. A., “Isolation Gown Use, Performance and Potential Compliance
gowns not meeting the definition of isolation gown in 3.1.7 as
Issues Identified by Infection Control Professionals,” American Journal of Infection
Control, Vol 40, No. 5, 2012, pp. e74–e75. defined by ANSI/AAMI PB70 are excluded from this standard.
Kilinc-Balci, F. S., Nwoko, J., and Hillam, T., “Evaluation of the Performance
1.3 This specification does not address protective clothing
of Isolation Gowns,” American Journal of Infection Control, Vol 43, No. 6, 2015, p.
S44. used for surgical applications, such as surgical gowns or
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3352/F3352M − 23b
decontamination gowns; protective clothing for the hands, such F2407/F2407M Specification for Surgical Gowns Intended
as surgical gloves, patient examination gloves, or other medical for Use in Healthcare Facilities
gloves; protective clothing for the head, such as goggles or face
F3050 Guide for Conformity Assessment of Personal Pro-
shields, surgical caps or hoods, surgical masks, or respirators;
tective Clothing and Equipment
protective clothing for the feet, such as operating room shoes,
2.2 AAMI Documents:
shoe covers, or surgical boots; or other types of protective
ANSI/AAMI PB70 Liquid Barrier Performance and Classi-
clothing and equipment worn by healthcare providers.
fication of Protective Apparel and Drapes Intended for
1.4 Units—The values stated in either SI units or inch-
Use in Healthcare Facilities
pound units are to be regarded separately as standard. The
AAMI TIR11 Selection and Use of Protective Apparel and
values stated in each system may not be exact equivalents;
Surgical Drapes in Healthcare Facilities
therefore, each system shall be used independently of the other.
2.3 AATCC Standards:
Combining values from the two systems may result in noncon-
AATCC 42 Water Resistance: Impact Penetration Test
formance with the standard.
AATCC 127 Water Resistance: Hydrostatic Pressure Test
1.5 This standard does not purport to address all of the
2.4 ANSI/ASQ Standards:
safety concerns, if any, associated with its use. It is the
ANSI/ASQ Z1.4 Sampling Procedures and Tables for In-
responsibility of the user of this standard to establish appro-
spection by Attributes
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use. ANSI/ASQ Z1.9 Sampling Procedures and Tables for In-
1.6 This international standard was developed in accor- spection by Variables for Percent Nonconforming
dance with internationally recognized principles on standard-
2.5 ISO Standards:
ization established in the Decision on Principles for the
ISO 2859-1 Sampling Plans for Inspection by Attributes
Development of International Standards, Guides and Recom-
ISO 3951 Sampling Procedures for Inspection by Variables
mendations issued by the World Trade Organization Technical
ISO 9001 Quality Management Systems—Requirements
Barriers to Trade (TBT) Committee.
ISO 9073-10 Textiles—Test Methods for Nonwovens—Part
10: Lint and Other Particles Generation in the Dry State
2. Referenced Documents
ISO 10993-5 Biological Evaluation of Medical Devices—
2.1 ASTM Standards:
Part 5: Tests for in Vitro Cytotoxicity
D751 Test Methods for Coated Fabrics
ISO 10993-7 Biological Evaluation of Medical Devices—
D1683/D1683M Test Method for Failure in Sewn Seams of
Part 7: Ethylene Oxide Sterilization Residuals
Woven Fabrics
ISO 10993-10 Biological Evaluation of Medical Devices—
D1776/D1776M Practice for Conditioning and Testing Tex-
Part 10: Tests for Skin Sensitization
tiles
ISO 10993-23 Biological Evaluation of Medical Devices—
D4966 Test Method for Abrasion Resistance of Textile
Part 23: Tests for Irritation
Fabrics (Martindale Abrasion Tester Method)
ANSI/AAMI/ISO 13485 Medical Devices—Quality Man-
D5034 Test Method for Breaking Strength and Elongation of
agement Systems—Requirements for Regulatory Pur-
Textile Fabrics (Grab Test)
poses
D5587 Test Method for Tearing Strength of Fabrics by
ISO/IEC 17025 General Requirements for the Competence
Trapezoid Procedure
of Testing and Calibration Laboratories
D6701 Test Method for Determining Water Vapor Transmis-
ISO/IEC 17026 Conformity Assessment—Example of a
sion Rates Through Nonwoven and Plastic Barriers
Certification Scheme for Tangible Products
F392/F392M Practice for Conditioning Flexible Barrier Ma-
terials for Flex Durability
2.6 Federal Standards:
F1154 Practices for Evaluating the Comfort, Fit, Function,
16 CFR 1610 Standard for the Flammability of Clothing
and Durability of Protective Ensembles, Ensemble
Textiles, Federal Register, Vol 40, No. 59891, Dec. 30,
Elements, and Other Components
F1494 Terminology Relating to Protective Clothing
F1671/F1671M Test Method for Resistance of Materials
Used in Protective Clothing to Penetration by Blood-
Available from Association for the Advancement of Medical Instrumentation
Borne Pathogens Using Phi-X174 Bacteriophage Penetra-
(AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://
tion as a Test System
www.aami.org.
F1868 Test Method for Thermal Resistance, Evaporative Available from American Association of Textile Chemists and Colorists
(AATCC), P.O. Box 12215, Research Triangle Park, NC 27709-2215, http://
Resistance, and Total Heat Loss Measurements of Cloth-
www.aatcc.org.
ing Materials Using a Sweating Hot Plate
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org.
Available from International Organization for Standardization (ISO), ISO
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Geneva, Switzerland, http://www.iso.org.
Standards volume information, refer to the standard’s Document Summary page on Available at https://www.ecfr.gov/current/title-16/chapter-II/subchapter-D/part-
the ASTM website. 1610.
F3352/F3352M − 23b
16 CFR 1611 Standard for the Flammability of Vinyl Plastic 3.1.7 isolation gown, n—item of protective clothing/apparel
Film, Federal Register, Vol 40, No. 59891, Dec. 30, used to protect healthcare personnel, visitors, and patients from
1975 the transfer of microorganisms and body fluids in patient
29 CFR 1910.1030 Occupational Exposure to Blood-Borne isolation situations.
Pathogens: Final Rule, Federal Register, Vol 66, No. 12, 3.1.7.1 Discussion—This definition is consistent with the
Jan. 18, 2001 definition provided by AAMI TIR11. Isolation gowns might
FDA Premarket Notification Requirements Concerning also be used to protect visitors in the healthcare setting.
Gowns Intended for Use in Health Care Settings— According to the Centers for Disease Control and Prevention’s
Guidance for Industry and Food and Drug Administration Guideline for Isolation Precautions, isolation gowns are worn
Staff to protect the healthcare workers’ arms and exposed body areas
13 during procedures and patient care activities when anticipating
2.7 INDA Standard:
contact with clothing, blood, body fluids, secretions, and
WSP 70.4 Water Vapor Transmission Rate—Mocon Method
excretions.
3.1.8 multiple-use, adj—refers to an item of protective
3. Terminology
clothing that is intended to be used several times with
3.1 Definitions:
appropriate care of the protective clothing item between uses.
3.1.1 blood-borne pathogen, n—an infectious bacterium or
3.1.8.1 Discussion—In this specification, multiple-use pro-
virus, or other disease-inducing microbe carried in blood or
tective clothing is subject to processing (laundering and
other potentially infectious body fluids.
sterilization, if used sterile) between each use.
3.1.2 body fluid, n—any liquid produced, secreted, or ex-
3.1.9 other potentially infectious materials, n—any
creted by the human body.
materials, other than blood or body fluids, containing blood-
3.1.2.1 Discussion—In this specification, body fluids in-
borne pathogens or materials that have been linked with the
clude liquids potentially infected with blood-borne pathogens,
potential transmission of infectious disease.
including, but not limited to: blood, semen, vaginal secretions,
3.1.10 protective clothing, n—an item of clothing/apparel
cerebrospinal fluid, synovial fluid and peritoneal fluid, amni-
that is specifically designed and constructed for the intended
otic fluid, saliva in dental procedures, urine, feces, bile, any
purpose of isolating all or part of the body from a potential
body fluid that is visibly contaminated with blood, and all body
hazard, or isolating the external environment from contamina-
fluids in situations where it is difficult or impossible to
tion by the wearer of the clothing.
differentiate between body fluids (see 29 CFR 1910.1030).
3.1.10.1 Discussion—For the purpose of this standard, pro-
tective clothing refers to isolation gowns. The primary purpose
3.1.3 critical zone(s), n—area of a gown where direct
contact with blood, body fluids, and other potentially infectious of the protective clothing is to act as a barrier between the
wearer and a hazard. However, the wearer may be the source of
materials is most likely to occur.
3.1.3.1 Discussion—Annex B of ANSI/AAMI PB70 pro- the hazard (contamination), so the product might also offer
vides examples of barrier classification for isolation gowns protection to the patient or others from the wearer.
stating that the entire isolation gown, including seams but
3.1.11 single-use, adj—refers to an item of protective cloth-
excluding cuffs, hems, and bindings, is required to have a
ing that is intended to be used once and then disposed.
barrier performance of at least Level 1.
3.2 For definitions of other protective clothing-related terms
3.1.4 critical zone component, n—any element, constituent,
used in this specification, refer to Terminology F1494.
or item incorporated into the critical zone, including the
4. Significance and Use
materials, seams, attachments, and closures.
3.1.4.1 Discussion—Seams, ties, attachments, closures, or 4.1 This specification provides minimum requirements for
isolation gowns used for protection of healthcare workers
other components of the gown are considered to be a critical
zone component. where the potential for exposure to blood, body fluids, and
other potentially infectious materials exists. This specification
3.1.5 flammability, n—those characteristics of a material
requires barrier testing based on the system of classifying
that pertain to its ignition and support of combustion.
gowns established in ANSI/AAMI PB70 and sets general
3.1.6 healthcare protective clothing, n—protective clothing/
safety requirements for isolation gowns based on biocompat-
apparel used in a healthcare setting.
ibility. Performance requirements are established for important
physical properties including tensile strength, tear strength, and
seam strength. Methods to be used for optional reporting of
10 performance of linting resistance, evaporative resistance, water
Available at https://www.ecfr.gov/current/title-16/chapter-II/subchapter-D/
part-1611. vapor transmission rate, abrasion resistance, and flex durability
Available at https://www.osha.gov/laws-regs/regulations/standardnumber/
are provided.
1910/1910.1030.
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/premarket-notification-requirements-concerning-gowns-intended-use- Siegel, J. D., Rhinehart, E., Jackson, M., and Chiarello, L., “2007 Guideline
health-care-settings. for Isolation Precautions: Preventing Transmission of Infectious Agents in Health
Available from Association of the Nonwoven Fabrics Industry (INDA), 1100 Care Settings,” American Journal of Infection Control, Vol 35, No. 10, 2007, pp.
Crescent Green, Suite 115, Cary, NC 27518, http://www.inda.org. S65–S164.
F3352/F3352M − 23b
4.2 Isolation gowns are either multiple-use or single-use Level 1. The manufacturer shall provide detailed information
products, as designated by the manufacturer. This specification about the barrier performance of each critical zone component.
is intended to provide the basis for manufacturer claims for
5.3 To ensure 360° coverage, isolation gowns shall be
isolation gown performance and efficacy. For multiple-use
designed in a manner that, at a minimum, ensures that both
gowns, this specification takes into account the anticipated care
arms and the front, sides, and back of the body from the knees
and maintenance of these products by examining test require-
up to but not including the neck, are fully covered during
ments for isolation gown materials both before and after the
movement and use when the correct gown size is worn.
maximum expected number of cycles for laundering and
sterilization, if used sterile.
NOTE 1—Isolation gowns are able to achieve 360° coverage with the
closure in the back, due to the overlap of the back portions of the gown.
4.3 While isolation gowns are classified for barrier perfor-
mance as specified in ANSI/AAMI PB70, this specification 5.4 Isolation gowns which are intended for reuse shall have
either a means for recording or marking the number of
establishes other design criteria, physical performance criteria,
labeling, and documentation requirements for isolation gowns processing cycles, or have an area (or multiple areas) on the
and their materials. gown that a processor could use to employ their own means for
4.3.1 By design, isolation gowns are required to provide recording or marking the number of processing cycles. The
360° protection to the healthcare worker in a manner that, at a recording area shall be visible/readable by the wearer.
minimum, ensures that both arms and the front, sides, and back
of the body from the knees up to but not including the neck, are
6. General Safety Requirements
fully covered during movement and use when the correct gown
6.1 Biocompatibility—Assessment shall be conducted to
size is worn. Multiple-use isolation gowns are required to
ensure the safety of the device. Materials used in the construc-
either have a means for recording or marking the number of
tion of isolation gowns are classified as external devices that
processing cycles or to have an area (or multiple areas) on the
contact breached or compromised surfaces for limited expo-
gown that a processor could use to employ their own means for
sures and shall pass the appropriate evaluations in accordance
recording or marking the number of processing cycles.
with ANSI/AAMI BE78. Alternatively, ISO 10993-5, ISO
4.3.2 Isolation gown materials are required to be non-
10993-10, and ISO 10993-23 are permitted to be used. Assess-
sensitizing, non-irritating, and non-cytotoxic to meet biocom-
ment shall be conducted to ensure the safety of the device.
patibility criteria.
Materials used in the construction of isolation gowns shall be
4.3.3 In addition to the barrier performance of the isolation
non-sensitizing, non-irritating, and non-cytotoxic.
gown material and seams, isolation gown material and seams
are also required to meet minimum strength requirements for
NOTE 2—The entire gown is considered body contacting. For the
purposes of evaluating gown biocompatibility, all materials and colors
tensile strength, tear strength, and seam strength that have been
used in the construction of isolation gowns should be part of the test
established on the basis of an analysis of workplace require-
samples. These materials should include all different materials and
ments. Isolation gowns with different barrier level claims shall
components used in the gown, including thread and elastic, seam binding,
meet the same minimum strength requirements regardless of
or knit cuffs, if used in the gown’s construction.
their barrier level.
NOTE 3—FDA categorizes the final, finished isolation gown as surface-
4.3.4 Additional properties for isolation gown material,
contacting devices that contact breached or compromised surfaces for
short-term exposure and therefore the isolation gown shall pass the
such as lint generation, evaporative resistance or water vapor
appropriate evaluations in accordance with ISO 10993, if supplied in the
transmission rate, abrasion resistance, and durability are op-
USA. Common test methods used for the assessment of the
tional for testing for the purpose of documenting performance.
biocompatibility, including cytotoxicity, skin sensitization, and irritation,
No minimum criteria are established for these properties, but
are ISO 10993-5, ISO 10993-10, and ISO 10993-23.
purchasers may use this information to compare products.
NOTE 4—If an isolation gown includes drugs, biologics, nanomaterials,
or antimicrobial/antiviral agents, additional testing or information (for
4.4 Isolation gowns differ from surgical gowns based on
example, chemical characterization) associated with a toxicological risk
their intended use and the expectation that the isolation gown
assessment may be warranted.
provides 360° protection to the healthcare worker. Specific
NOTE 5—The common test methods for biocompatibility of finished
requirements for surgical gowns beyond the barrier perfor-
isolation gowns are in vitro cytotoxicity (for example, MEM elution),
irritation, and skin sensitization.
mance of surgical gown materials and seams are provided in
NOTE 6—If the isolation gown is sterilized by the ethylene oxide
Specification F2407/F2407M.
sterilization method, then the residual ethylene oxide and ethylene
4.5 Additional information for the testing, selection, and use
chlorohydrin shall be within the maximum allowable limits specified in
of isolation gowns is provided in AAMI TIR11. ISO 10993-7, or the isolation gown shall exhibit negligible irritation as
specified in ISO 10993-23.
5. Design Requirements
6.2 Flame Spread—Materials used in the construction of
isolation gowns shall meet the requirements for Class 1
5.1 Isolation gowns shall be designed to comply with the
“normal flammability” in accordance with 16 CFR Part 1610
barrier performance requirements of ANSI/AAMI PB70.
(or 16 CFR 1611 if the material is vinyl) before and after the
5.2 For isolation gowns and other gowns intended for use in
conditioning specified in Section 9.
isolation applications, the critical zone shall comprise the
entire gown, including the seams but excluding the cuffs, hems, 6.3 Natural Rubber Latex—Gowns that contain natural
and bindings, and shall have a barrier performance of at least rubber latex shall include the latex caution statement CFR
F3352/F3352M − 23b
801.437, “THIS PRODUCT CONTAINS NATURAL RUB- acceptance level (Alpha = 0.05), with the maximum RQL set at
BER LATEX WHICH MAY CAUSE ALLERGIC REAC- 20 % at a 10 % acceptance level (Beta = 0.10). For an original
TION.” (See 11.3 for labeling requirements.) classification of a product, the sampling plan shall be applied
independently to each material or component, or both, and the
7. Barrier and Physical Property Requirements
finished product across multiple non-consecutive lots (three or
more with a minimum sample size of 32 per lot).
7.1 The barrier performance and physical property perfor-
8.2.1 Examples of acceptable sampling plans for the other
mance requirements of single and multiple-use isolation gowns
physical properties are found in references such as ANSI/ASQ
shall be tested and reported as specified in Table 1. Multiple-
Z1.4 and Z1.9, ISO 2859-1, and ISO 3951.
use isolation gowns shall meet these minimum requirements
after one washing/drying and sterilization cycle, if used sterile,
8.3 Material, seam, and point-of-attachment specimens shall
and after the maximum number of cycles of washing/drying
be removed from manufactured isolation gowns and condi-
and sterilization processing, if used sterile, specified by the
tioned in accordance with Section 9, and shall be representative
manufacturer.
of the actual finished gowns.
8.3.1 If different types of seams are used in the construction
NOTE 7—Tensile and tear strength requirements apply to both machine
(MD) and cross-machine (CD) direction of material. The seam strength is of a gown, each type of seam shall be separately tested.
tested perpendicular to the seam and shall be tested in locations where the
8.3.2 If the seam/point of attachment is located close to the
material orientations are different.
edge (less than 2 in. to the edge), barrier resistance testing is
7.2 Additional performance properties that can be reported not required on those areas.
are listed in Table 2.
9. Conditioning
NOTE 8—Refer to Section 10 and Appendix X1 for more information
9.1 General Requirements—Testing used for demonstrating
about Table 1 and Table 2 test methods.
performance of isolation gowns shall be conducted after
8. Sampling ambient conditioning on both single and multiple-use products
as specified in 9.2. For isolation gowns where laundering and
8.1 Sample size for the physical property requirements shall
sterilization (if used sterile) are required before use, the
be determined as following for each lot. For tensile strength,
manufacturer must conduct testing outlined in this specification
take five samples from the machine direction and eight samples
after all required laundering and sterilization processing (if
from the cross-machine direction for each test condition
used sterile) have been completed. If the manufacturer is
described in 9.1 – 9.3, as applicable to a material specification.
claiming continued barrier performance after multiple uses,
For tear strength, take five samples from the machine direction
then the manufacturer must conduct testing outlined in this
and five samples from the cross-machine direction, for each
specification after one washing/drying and sterilization cycle,
test condition described in 9.1 – 9.3, as applicable to a material
if used sterile, and the maximum number of cycles of washing/
specification. For seam strength, take five test samples for each
drying and sterilization processing, if used sterile (9.3), speci-
specified seam assembly used in the isolation gown for each
fied by the manufacturer using samples taken from the same
test condition described in 9.1 – 9.3, as applicable to a material
lots.
specification. In these test methods, each sample shall be taken
from a different garment and minimum three non-consecutive 9.2 Ambient Conditioning—All specimens shall be condi-
lots. tioned at a temperature of 21 6 3 °C [70 6 5 °F] and relative
humidity of 65 6 5 % for at least 24 h in accordance with
8.2 Sample size for the barrier requirements shall be suffi-
Practice D1776/D1776M, unless otherwise specified by the
cient to establish an acceptable statistical confidence interval
selected test method.
for the property being measured. Test specimens shall be
selected randomly according to a statistical sampling plan that 9.3 Processing Conditioning—Specimens from multiple-
is appropriate for the type of data being generated. For use isolation gowns shall be processed (laundered, sterilized, or
examples of suitable sampling plans specific to barrier perfor- both) using the manufacturer’s recommended processing pro-
mance properties, see ANSI/AAMI PB70 Annex C. In this cedures. The total number of processing cycles specified in the
document, the maximum AQL is set at 4.0 % at a 95 % manufacturer’s claims shall be used.
TABLE 1 Barrier Performance and Physical Property Performance Requirements of Single and Multiple-Use Isolation Gowns
AAMI PB70 Level
Property Material Type Test Method
1 2 3 4
A
Barrier Performance All AATCC 42 #4.5 g #1.0 g #1.0 g N/A
All AATCC 127 N/A $20 cm $50 cm N/A
All ASTM F1671/F1671M N/A N/A N/A Pass
Tensile Strength All ASTM D5034 $30 N [$7 lbf] $30 N [$7 lbf] $30 N [$7 lbf] $30 N [$7 lbf]
Tear Strength All ASTM D5587 $10 N [$2.3 lbf]
...

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: F3352/F3352M − 23a F3352/F3352M − 23b
Standard Specification for
Isolation Gowns Intended for Use in Healthcare Facilities
This standard is issued under the fixed designation F3352/F3352M; 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 personal protective equipment, including isolation gowns, is worn by healthcare workers
to protect the patient, the healthcare worker, and visitors from the transfer of microorganisms, blood
and other body fluids, and other contaminants.
Healthcare workers and patients can be exposed to body fluids and other potentially infectious
materials 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), as well as other healthcare-associated infections. Since engineering
controls cannot eliminate all possible exposures, attention is placed on reducing the potential for direct
skin contact with microorganisms, blood or other body fluids, and other potentially infectious
materials through the use of protective clothing.
The ASTM F23.40 Biological Subcommittee work group surveyed infection preventionists to
determine use/wear issues, familiarity with isolation gown performance standards, and to identify
compliance perceptions and problems. Results of this survey clearly indicated issues with the
physical performance of the isolation gowns used in healthcare settings. Development of this standard,
which includes performance and design criteria for isolation gowns, is intended to assist end users in
correct gown selection. The minimum criteria in this specification were established based on the
findings of a study in collaboration with National Institute for Occupational Safety and Health and
committee discussions.
This specification addresses the performance of isolation gowns designed to protect the healthcare
worker, the patient, and visitors from exposure to blood, body fluids, and other potentially infectious
materials during patient care or patient procedures.
This specification establishes uniform testing and reporting requirements for isolation gown
manufacturers in order to provide information to end users that can be used in making informed
decisions in the evaluation, selection, and purchase of isolation gowns according to the anticipated
exposures.
1. Scope
1.1 This specification establishes minimum requirements for the performance and labeling of isolation gowns intended for use by
healthcare workers to provide protection for standard and transmission-based precautions. The intended use of this specification
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 2019. Last previous edition approved in 2023 as
F3352/F3352M – 23.F3352/F3352M – 23a. DOI: 10.1520/F3352_F3352M-23A.10.1520/F3352_F3352M-23B.
Cloud, R., Favret, U. B., Cunningham, T., Daley, J., Harris, L. G., Kilinc-Balci, F. S., and Lewis, J. A., “Isolation Gown Use, Performance and Potential Compliance
Issues Identified by Infection Control Professionals,” American Journal of Infection Control, Vol 40, No. 5, 2012, pp. e74–e75.
Kilinc-Balci, F. S., Nwoko, J., and Hillam, T., “Evaluation of the Performance of Isolation Gowns,” American Journal of Infection Control, Vol 43, No. 6, 2015, p. S44.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F3352/F3352M − 23b
is to ensure the performance properties of isolation gowns for the protection of the wearer. Four levels of barrier properties for
isolation gowns are specified in ANSI/AAMI PB 70, and are included in this specification for reference purposes.
1.2 There are other types of gowns that are used in healthcare settings, including: cover gowns, procedure gowns, comfort gowns,
precaution gowns, and open-back gowns. All gowns not meeting the definition of isolation gown in 3.1.7 as defined by
ANSI/AAMI PB70 are excluded from this standard.
1.3 This specification does not address protective clothing used for surgical applications, such as surgical 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.
1.4 Units—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.
1.5 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
F392/F392M Practice for Conditioning Flexible Barrier Materials for Flex Durability
F1154 Practices for Evaluating the Comfort, Fit, Function, and Durability of Protective Ensembles, Ensemble Elements, and
Other Components
F1494 Terminology Relating to Protective Clothing
F1671/F1671M Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens
Using Phi-X174 Bacteriophage Penetration as a Test System
F1868 Test Method for Thermal Resistance, Evaporative Resistance, and Total Heat Loss Measurements of Clothing Materials
Using a Sweating Hot Plate
F2407/F2407M Specification for Surgical Gowns Intended for Use in Healthcare Facilities
F3050 Guide for Conformity Assessment of Personal Protective Clothing and Equipment
2.2 AAMI Documents:
ANSI/AAMI PB70 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in
Healthcare Facilities
AAMI TIR11 Selection and Use of Protective Apparel and Surgical Drapes in Healthcare Facilities
2.3 AATCC Standards:
AATCC 42 Water Resistance: Impact Penetration Test
AATCC 127 Water Resistance: Hydrostatic Pressure Test
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 Association for the Advancement of Medical Instrumentation (AAMI), 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633, http://www.aami.org.
Available from American Association of Textile Chemists and Colorists (AATCC), P.O. Box 12215, Research Triangle Park, NC 27709-2215, http://www.aatcc.org.
F3352/F3352M − 23b
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 for Inspection by Variables
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
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
ANSI/AAMI/ISO 13485 Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes
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
29 CFR 1910.1030 Occupational Exposure to Blood-Borne Pathogens: Final Rule, Federal Register, Vol 66, No. 12, Jan. 18,
FDA Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings—Guidance for Industry
and Food and Drug Administration Staff
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.
3.1.2 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,
urine, feces, bile, 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 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 isolation gowns stating that the entire isolation
gown, including seams but excluding cuffs, hems, and bindings, is required to have a barrier performance of at least Level 1.
3.1.4 critical zone component, n—any element, constituent, or item incorporated into the critical zone, including the materials,
seams, attachments, and closures.
3.1.4.1 Discussion—
Seams, ties, attachments, closures, or other components of the gown are considered to be a critical zone component.
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
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.
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.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030.
Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/premarket-notification-
requirements-concerning-gowns-intended-use-health-care-settings.
Available from Association of the Nonwoven Fabrics Industry (INDA), 1100 Crescent Green, Suite 115, Cary, NC 27518, http://www.inda.org.
F3352/F3352M − 23b
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/apparel used in a healthcare setting.
3.1.7 isolation gown, n—item of protective clothing/apparel used to protect healthcare personnel, visitors, and patients from the
transfer of microorganisms and body fluids in patient isolation situations.
3.1.7.1 Discussion—
This definition is consistent with the definition provided by AAMI TIR11. Isolation gowns might also be used to protect visitors
in the healthcare setting. According to the Centers for Disease Control and Prevention’s Guideline for Isolation Precautions,
isolation gowns are worn to protect the healthcare workers’ arms and exposed body areas during procedures and patient care
activities when anticipating contact with clothing, blood, body fluids, secretions, and excretions.
3.1.8 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 uses.
3.1.8.1 Discussion—
In this specification, multiple-use protective clothing is subject to processing (laundering and sterilization, if used sterile) between
each use.
3.1.9 other potentially infectious materials, n—any materials, other than blood or body fluids, containing blood-borne pathogens
or materials that have been linked with the potential transmission of infectious disease.
3.1.10 protective clothing, n—an item of clothing/apparel that is specifically designed and constructed for the intended purpose
of isolating all or part of the body from a potential hazard, or isolating the external environment from contamination by the wearer
of the clothing.
3.1.10.1 Discussion—
For the purpose of this standard, protective clothing refers to isolation gowns. The primary purpose of the protective clothing is
to act as a barrier between the wearer and a hazard. However, the wearer may be the source of the hazard (contamination), so the
product might also offer protection to the patient or others from the wearer.
3.1.11 single-use, adj—refers to an item of protective clothing that is intended to be used once and then disposed.
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 isolation gowns used for protection of healthcare workers where the
potential for exposure to blood, body fluids, and other potentially infectious materials exists. This specification requires barrier
testing based on the system of classifying gowns established in ANSI/AAMI PB70 and sets general safety requirements for
isolation gowns based on biocompatibility. 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, abrasion resistance, and flex durability are provided.
4.2 Isolation 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 isolation 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 isolation
gown materials both before and after the maximum expected number of cycles for laundering and sterilization, if used sterile.
4.3 While isolation gowns are classified for barrier performance as specified in ANSI/AAMI PB70, this specification establishes
other design criteria, physical performance criteria, labeling, and documentation requirements for isolation gowns and their
materials.
4.3.1 By design, isolation gowns are required to provide 360° protection to the healthcare worker in a manner that, at a minimum,
Siegel, J. D., Rhinehart, E., Jackson, M., and Chiarello, L., “2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Health Care
Settings,” American Journal of Infection Control, Vol 35, No. 10, 2007, pp. S65–S164.
F3352/F3352M − 23b
ensures that both arms and the front, sides, and back of the body from the knees up to but not including the neck, are fully covered
during movement and use when the correct gown size is worn. Multiple-use isolation gowns are required to either have a means
for recording or marking the number of processing cycles or to 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 processing cycles.
4.3.2 Isolation gown materials are required to be non-sensitizing, non-irritating, and non-cytotoxic to meet biocompatibility
criteria.
4.3.3 In addition to the barrier performance of the isolation gown material and seams, isolation gown material and seams are also
required to meet minimum strength requirements for tensile strength, tear strength, and seam strength that have been established
on the basis of an analysis of workplace requirements. Isolation gowns with different barrier level claims shall meet the same
minimum strength requirements regardless of their barrier level.
4.3.4 Additional properties for isolation gown material, such as lint generation, evaporative resistance or water vapor transmission
rate, abrasion resistance, 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.
4.4 Isolation gowns differ from surgical gowns based on their intended use and the expectation that the isolation gown provides
360° protection to the healthcare worker. Specific requirements for surgical gowns beyond the barrier performance of surgical
gown materials and seams are provided in Specification F2407/F2407M.
4.5 Additional information for the testing, selection, and use of isolation gowns is provided in AAMI TIR11.
5. Design Requirements
5.1 Isolation gowns shall be designed to comply with the barrier performance requirements of ANSI/AAMI PB70.
5.2 For isolation gowns and other gowns intended for use in isolation applications, the critical zone shall comprise the entire gown,
including the seams but excluding the cuffs, hems, and bindings, and shall have a barrier performance of at least Level 1. The
manufacturer shall provide detailed information about the barrier performance of each critical zone component.
5.3 To ensure 360° coverage, isolation gowns shall be designed in a manner that, at a minimum, ensures that both arms and the
front, sides, and back of the body from the knees up to but not including the neck, are fully covered during movement and use
when the correct gown size is worn.
NOTE 1—Isolation gowns are able to achieve 360° coverage with the closure in the back, due to the overlap of the back portions of the gown.
5.4 Isolation 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 processing cycles. The recording area shall be visible/readable by the wearer.
6. General Safety Requirements
6.1 Biocompatibility—Assessment shall be conducted to ensure the safety of the device. Materials used in the construction of
isolation gowns are 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 isolation gowns shall be non-sensitizing, non-irritating, and non-cytotoxic.
NOTE 2—The entire gown is considered body contacting. For the purposes of evaluating gown biocompatibility, all materials and colors used in the
construction of isolation gowns should be part of the test samples. These materials should include all different materials and components used in the gown,
including thread and elastic, seam binding, or knit cuffs, if used in the gown’s construction.
NOTE 3—FDA categorizes the final, finished isolation gown as surface-contacting devices that contact breached or compromised surfaces for short-term
exposure and therefore the isolation 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.
F3352/F3352M − 23b
NOTE 4—If an isolation 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 5—The common test methods for biocompatibility of finished isolation gowns are in vitro cytotoxicity (for example, MEM elution), irritation, and
skin sensitization.
NOTE 6—If the isolation gown is sterilized by the ethylene oxide sterilization method, then the residual ethylene oxide and ethylene chlorohydrin shall
be within the maximum allowable limits specified in ISO 10993-7, or the isolation gown shall exhibit negligible irritation as specified in ISO 10993-23.
6.2 Flame Spread—Materials used in the construction of isolation 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.
6.3 Natural Rubber Latex—Gowns that contain natural rubber latex shall include the latex caution statement CFR 801.437, “THIS
PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTION.” (See 11.3 for labeling
requirements.)
7. Barrier and Physical Property Requirements
7.1 The barrier performance and physical property performance requirements of single and multiple-use isolation gowns shall be
tested and reported as specified in Table 1. Multiple-use isolation gowns shall meet these minimum requirements after one
washing/drying and sterilization cycle, if used sterile, and after the maximum number of cycles of washing/drying and sterilization
processing, if used sterile, specified by the manufacturer.
NOTE 7—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.
7.2 Additional performance properties that can be reported are listed in Table 2.
NOTE 8—Refer to Section 10 and Appendix X1 for more information about Table 1 and Table 2 test methods.
8. Sampling
8.1 Sample size for the physical property requirements shall be determined as following 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
– 9.3, 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 – 9.3, as applicable to a material specification. For seam
strength, take five test samples for each specified seam assembly used in the isolation gown for each test condition described in
9.1 – 9.3, as applicable to a material specification. In these test methods, each sample shall be taken from a different garment and
minimum three non-consecutive lots.
TABLE 1 Barrier Performance and Physical Property Performance Requirements of Single and Multiple-Use Isolation Gowns
AAMI PB70 Level
Property Material Type Test Method
1 2 3 4
A
Barrier Performance All AATCC 42 #4.5 g #1.0 g #1.0 g N/A
All AATCC 127 N/A $20 cm $50 cm N/A
All ASTM F1671/F1671M N/A N/A N/A Pass
Tensile Strength All ASTM D5034 $30 N [$7 lbf] $30 N [$7 lbf] $30 N [$7 lbf] $30 N [$7 lbf]
Tear Strength Woven textiles ASTM D5587 $10 N [$2.3 lbf] $10 N [$2.3 lbf] $10 N [$2.3 lbf] $10 N [$2.3 lbf]
Tear Strength All ASTM D5587 $10 N [$2.3 lbf] $10 N [$2.3 lbf] $10 N [$2.3 lbf] $10 N [$2.3 lbf]
Nonwoven textiles, ASTM D5733
films, nonwoven and
film composites
Seam Strength All ASTM D1683/D1683M $30 N [$7 lbf] $30 N [$7 lbf] $30 N [$7 lbf] $30 N [$7 lbf]
A
According to ANSI/AAMI PB70 with 4 % acceptable quality level (AQL), 20 % rejectable quality level (RQL).
F3352/F3352M − 23b
A
TABLE 2 Optional Tests Documentation Requirements (Documentation Only)
Performance Property Test Method Subsection Reported Data
B
Lint Generation ISO 9073-10 10.3.1 Particle count for each side, unless material is the
same on each side
Evaporative Resistance or ASTM F1868 10.3.2 Average evaporative resistance
Water Vapor Transmission Rate or ASTM D6701 10.3.3 Average water vapor transmission rate
C 2
Water Vapor Transmission Rate (Mocon Method) WSP 70.4 10.3.3 Average WVTR or g/m /24 h
Abrasion Resistance (Martindale) ASTM D4966 10.3.4 Average abrasion resistance
Flex Durability ASTM F392/F392M 10.3.4 Average flex durability
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, Test Method D6701, or WSP 70.4. Appendix
X1 provides a comparison of the three methods with their respective procedures, applications, 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 isolation 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 isolation 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.
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 classi
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