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Significance and Use
4.1 This specification provides requirements for surgical gowns used for protection of healthcare workers where the potential for exposure to blood, body fluids, and other potentially infectious materials exists. The specification requires barrier testing based on the system of classifying gowns established in AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Documentation and reporting requirements are set for important physical properties including tensile strength, tear resistance, seam strength, linting resistance, evaporative resistance testing, and water vapor transmission rate.
4.2 This specification does not address protective clothing used for non-surgical applications, such as isolation 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 health care providers.
4.3 Surgical gowns are either multiple-use or single-use products as designated by the manufacturer. This specification is intended to provide the basis for manufacturer claims for surgical gown performance and efficacy. For multiple-use gowns, this specification takes into account the anticipated care and maintenance of these products, by examining test requirements for surgical gown materials both before and after the maximum expected number of cycles for laundering and sterilization.
4.5 While surgical gowns are classified for barrier performance as specified in AAMI PB70, this specification establishes certain other physical performance and documentation requirements for surgical gowns and their materials. Design requirements and recommendations are also provided for surgical gowns.
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 and are included in this specification for reference purposes.
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.
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
ICS Number Code 11.140 (Hospital equipment); 13.340.10 (Protective clothing)
UNSPSC Code 42131702(Surgical gowns)