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ASTM F2407-06(2013)e1

Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities

Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities F2407-06R13E01 ASTM|F2407-06R13E01|en-US Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities Standard new BOS Vol. 11.03 Committee F23
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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.

4.4 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 3Information 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.

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 and are included in this specification for reference purposes.

Note 1Some properties require minimum performance and others are for documentation only.
Note 2AAMI PB70 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.

1.5 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.

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Details
Book of Standards Volume: 11.03
Developed by Subcommittee: F23.40
Pages: 8
DOI: 10.1520/F2407-06R13E01
ICS Code: 11.140; 13.340.10