Standards for Surgical Gowns-Henan Medical Technology Co.,Ltd

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Standards for Surgical Gowns
1970-01-01

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.

①Tensile Strength: ASTM D5034, ASTM D1682

②Tear resistance: ASTM D5587(woven), ASTM D5587 (nonwoven), ASTM D1424

③Seam Strength: ASTM D751 (stretch woven or knit)

④Lint Generation (ISO 9073 Part 10)

⑤Water vapor transmission (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), 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.

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