1. 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 AAMI PB70:2003 and are included in this specification for reference purposes.

Some properties require minimum performance and others are for documentation only.

AAMI PB70:2003 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.

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 and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

D751 Test Methods for Coated Fabrics

D1683 Test Method for Failure in Sewn Seams of Woven Apparel Fabrics

D1776 Practice for Conditioning and Testing Textiles

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

F1494 Terminology Relating to Protective Clothing

F1671 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

Keywords

barrier performance; critical zone; healthcare; hydrostatic pressure; impact penetration; physical properties; protective clothing; surgical gown; viral penetration resistance;

ICS Code

ICS Number Code 11.140 (Hospital equipment); 13.340.10 (Protective clothing)

DOI: 10.1520/F2407-06

ASTM International is a member of CrossRef.