This specification establishes the requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. It does not however cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. Barrier testing shall be conducted to determine the impact penetration, hydrostatic resistance, and viral penetration resistance performance of the critical zone(s) of the surgical gown. The physical properties of the critical zone(s) of the surgical gown shall also be tested and shall conform to the following requirements: tensile strength, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission rate. General safety requirements shall be set based on biocompatibility, sterility assurance, flame spread, and natural rubber latex specifications.
This abstract is a brief summary of the referenced standard. It is informational only and not an official part of the standard; the full text of the standard itself must be referred to for its use and application. ASTM does not give any warranty express or implied or make any representation that the contents of this abstract are accurate, complete or up to date.
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.Note 1
Some properties require minimum performance and others are for documentation only.Note 2
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.
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
AAMI/ANSI BE78:2002 Biological Evaluation of Medical Devices, Part 10: Test for Irritation and Sensitization
AATCC 127 Water Resistance: Hydrostatic Pressure Test
barrier performance; critical zone; healthcare; hydrostatic pressure; impact penetration; physical properties; protective clothing; surgical gown; viral penetration resistance;
ICS Number Code 11.140 (Hospital equipment); 13.340.10 (Protective clothing)
ASTM International is a member of CrossRef.
Citing ASTM Standards
[Back to Top]