Labeling that shows a product has been tested and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown.
The performance of gowns is tested using consensus standards:
American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns: tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission.
Below is a summary of ASTM F2407 standard recognized by the FDA.
Tensile Strength: ASTM D5034, ASTM D1682
Tear resistance: ASTM D5587(woven), ASTM D5587 (non-woven), ASTM D1424
Seam Strength: ASTM D751 (stretch woven or knit)
Lint Generation (ISO 9073 Part 10)
Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (non-woven), ASTM D737-75
American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Below is a table summarizing the ANSI/AAMI PB70 standard recognized by the FDA.
Conformance with recognized consensus standards is voluntary for a medical device manufacturer. A manufacturer may choose to conform to applicable recognized standards or may choose to address relevant issues in another manner.
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