ASTM F2407-20
Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

Standard No.

ASTM F2407-20

Release Date

2020

Published By

American Society for Testing and Materials (ASTM)

Status

Be replaced

Replace By

ASTM F2407/F2407M-22

Latest

ASTM F2407/F2407M-23a

Scope

1.1 This specification establishes requirements for the performance, documentation, and labeling of surgical gowns used in the 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 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 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 Sept. 1, 2020. Published September 2020. Originally approved in 2006. Last previous edition approved in 2013 as F2407 – 06 (2013)ɛ1 . DOI: 10.1520/F2407-20. 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 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 F2407-20 Referenced Document

• ANSI/AAMI BE78 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity - Amendment 1
• ANSI/AAMI PB70 
• ANSI/AAMI ST65 
• 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 E96/E96M Standard Test Methods for Gravimetric Determination of Water Vapor Transmission Rate of Materials
• 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 F1868 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
• ASTM F3352 Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
• ISO 11134 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
• ISO 11135 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices AMENDMENT 1: Revision of Annex E, Single batch release
• ISO 11137 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Technical Corrigendum 1
• ISO 13683 Sterilization of health care products - Requirements for validation and routine control of moist heat sterilization in health care facilities
• 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

ASTM F2407-20 history

• 2023 ASTM F2407/F2407M-23a Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• 2023 ASTM F2407/F2407M-23 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• 2022 ASTM F2407/F2407M-22a Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• 2022 ASTM F2407/F2407M-22 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• 2020 ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• 2006 ASTM F2407-06(2013)e1 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
• 2006 ASTM F2407-06 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities