Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

Importancia y uso:

4.1 This specification provides minimum 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 ANSI/AAMI PB70 and sets general safety requirements for surgical gowns based on biocompatibility, sterility assurance, and flame spread. Performance requirements are established for important physical properties, including tensile strength, tear strength, and seam strength. Methods to be used for optional reporting of performance of linting resistance, evaporative resistance, water vapor transmission rate, and abrasion resistance are provided.

4.2 This specification does not address protective clothing used for nonsurgical 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 healthcare 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.

4.4 Additional information on the processing of multiple-use surgical gowns is provided in ANSI/AAMI ST65.

4.5 While surgical gowns are classified for barrier performance as specified in ANSI/AAMI PB70, this specification establishes other design criteria, minimum physical performance criteria, labeling, and documentation requirements for surgical gowns and their materials.

4.5.1 In addition to the barrier performance of the surgical gown material and seams, surgical gown material and seams are also required to meet minimum requirements for tensile strength, tear strength, and seam strength that have been established on the basis of an analysis of workplace requirements. Surgical gowns with different barrier level claims shall meet the same minimum strength requirements regardless of their barrier level.

4.5.2 Additional properties for surgical gown material such as lint generation, evaporative resistance or water vapor transmission rate, and durability are optional for testing for the purpose of documenting performance. No minimum criteria are established for these properties, but purchasers may use this information to compare products.

4.5.3 Surgical gowns differ from isolation gowns based on their intended use and anticipated location of liquid contact. Specific requirements for isolation gowns beyond the barrier performance of isolation gown materials and seams are provided in Specification F3352/F3352M.

4.6 Additional information for the testing, selection, and use of surgical gowns is provided in AAMI TIR11.

Subcomité:

F23.40

Referida por:

F1154-24, F3352_F3352M-23B, F3267-22

Volúmen:

11.03

Número ICS:

11.140 (Hospital equipment), 13.340.10 (Protective clothing)

Palabras clave:

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