ASTM F3352/F3352M-23b
(Specification)Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
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.
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F3352/F3352M − 23b
Standard Specification for
1
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
2
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
3
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/
1
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-
2
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.
3
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
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F3352/F3352M
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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
1
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
2
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
3
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
1
This specification is under the jurisdiction of ASTM Committee F23 on Personal Protective Clothing and Equipment and is the direct responsibility of Subcommittee
F23.40 on Biological.
Current edition approved Feb. 1, 2023June 1, 2023. Published February 2023July 2023. Originally approved in 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.
2
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.
3
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
1
---------------------- Page: 1 ----------------------
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 defin
...
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