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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 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 (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
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
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 and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
F2407 Specification for Surgical Gowns Intended for Use in Healthcare Facilities
AAMI DocumentsAAMI TIR11 Selection and Use of Protective Apparel and Surgical Drapes in Healthcare Facilities ANSI/AAMI PB70
ISO StandardsISO 2859-1 Sampling Plans for Inspection by Attributes ISO 3951 Sampling Procedures for Inspection by Variables ISO 9073-10 TextilesTest Methods for NonwovensPart 10: Lint and Other Particles Generation in the Dry State ISO/ANSI/AAMI 10993-10
ANSI/ASQ StandardsANSI/ASQ Z1.4 ANSI/ASQ Z1.9 Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
AATCC StandardsAATCC 127 Water Resistance: Hydrostatic Pressure Test AATCC 42
INDA StandardWSP 70.4 Water Vapor Transmission RateMocon Method
Federal Standard29 CFR 1910.1030 Bloodborne Pathogens
ICS Number Code 11.020.99 (Other standards related to health care in general); 11.100.99 (Other standards related to laboratory medicine); 13.340.10 (Protective clothing)
|Link to Active (This link will always route to the current Active version of the standard.)|
ASTM F3352-19, Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities, ASTM International, West Conshohocken, PA, 2019, www.astm.orgBack to Top