Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities (Includes all amendments and changes 7/7/2023).
STANDARD published on 1.6.2023
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Designation standards: ASTM F2407/F2407M-23a
Publication date standards: 1.6.2023
The number of pages: 11
Approximate weight : 33 g (0.07 lbs)
Country: American technical standard
Category: Technical standards ASTM
This specification establishes the requirements for the performance, documentation, and labeling of surgical gowns used in the healthcare facilities. It does not however cover all the requirements that a healthcare facility deems necessary to select a product, nor does it address criteria for evaluating experimental products. Barrier testing shall be conducted to determine the impact penetration, hydrostatic resistance, and viral penetration resistance performance of the critical zone(s) of the surgical gown. The physical properties of the critical zone(s) of the surgical gown shall also be tested and shall conform to the following requirements: tensile strength, tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission rate. General safety requirements shall be set based on biocompatibility, sterility assurance, flame spread, and natural rubber latex specifications.
Keywords:
barrier performance, critical zone, healthcare, hydrostatic pressure, impact penetration, physical properties, protective clothing, surgical gown, viral penetration resistance,, ICS Number Code 11.140 (Hospital equipment),13.340.10 (Protective clothing)