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.

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

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.

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

Note 3-Information on barrier classes in AAMI TIR11 does not currently match the levels established in AAMI PB70. However, AAMI TIR11 provides other useful information that is intended to aid in the selection and use of surgical gowns.