ASTM F3352/F3352M-23a
Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities

Standard No.

ASTM F3352/F3352M-23a

Release Date

2023

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F3352/F3352M-23b

Latest

ASTM F3352/F3352M-23b

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 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, 2023. Published February 2023. Originally approved in 2019. Last previous edition approved in 2023 as F3352/F3352M – 23. DOI: 10.1520/F3352_F3352M-23A. 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 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. 1 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 inchpound 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.

ASTM F3352/F3352M-23a Referenced Document

• ANSI/AAMI PB70 
• ANSI/AAMI/ISO 13485 Medical devices—Quality management systems— Requirements for regulatory purposes
• 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
• ASTM D1683/D1683M Standard Test Method for Failure in Sewn Seams of Woven Fabrics
• ASTM D1776/D1776M Standard Practice for Conditioning and Testing Textiles
• ASTM D4966 Standard Test Method for Abrasion Resistance of Textile Fabrics (Martindale Abrasion Tester Method)
• ASTM D5034 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
• ASTM D5587 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
• ASTM D5733 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure
• ASTM D6701 Standard Test Method for Determining Water Vapor Transmission Rates Through Nonwoven and Plastic Barriers
• ASTM D751 Standard Test Methods for Coated Fabrics
• ASTM F1154 Standard Practices for Qualitatively Evaluating the Comfort, Fit, Function, and Integrity of Chemical-Protective Suit Ensembles
• ASTM F1494 Standard Terminology Relating to Protective Clothing
• ASTM F1671/F1671M Standard 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
• ASTM F1868 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
• ASTM F2407/F2407M Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities*， 2023-06-01 Update
• ASTM F3050 Standard Guide for Conformity Assessment of Personal Protective Clothing and Equipment
• ASTM F392/F392M Standard Practice for Conditioning Flexible Barrier Materials for Flex Durability*， 2023-10-01 Update
• ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
• ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
• ISO 2859-1 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection; Technical Corrigendum 1
• ISO 3951 Sampling procedures and charts for inspection by variables for percent nonconforming
• ISO 9001 Quality management systems - Requirements [Spanish version]
• ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories [Standard in French]

ASTM F3352/F3352M-23a history

• 2023 ASTM F3352/F3352M-23b Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
• 2023 ASTM F3352/F3352M-23a Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
• 2023 ASTM F3352/F3352M-23 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
• 2022 ASTM F3352/F3352M-22 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
• 2019 ASTM F3352-19 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities