ASTM F 2407

Scope

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 ANSI/AAMI PB70 and are included in this specification for reference purposes.

NOTE 1—Some properties require minimum performance and others are for documentation only.

NOTE 2—ANSI/AAMI 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.

Significance and Use

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 resistance, 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.

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.

The below methods from ASTM F3352 are performed at SGS-IPS Testing:

• ANSI/AAMI PB70, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
• AATCC 42, Water Resistance: Impact Penetration
• AATCC 127, Water Resistance: Hydrostatic Pressure
• ASTM D5034, Breaking Strength and Elongation of Textile Fabrics (Grab Test)
• ASTM D5587, Tearing Strength of Fabrics by the Trapezoid Procedure
• ASTM D5733, Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure
• ASTM D1683, Failure in Sewn Seams of Woven Apparel Fabrics
• ISO 9073-10, Lint and other particles generation in the dry state
• ASTM D 6701, Water Vapor Transmission Rate

Please note:
SGS-IPS cannot sell or otherwise provide standards, specifications, or test procedures to third parties.

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