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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Keyword: gown
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07/09/2014 Sterility 14-286 Complete ANSI AAMI ST65:2008/(R)2018 Processing of reusable surgical textiles for use in health care facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-487 Partial ANSI AAMI PB70:2022 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
05/29/2023 General Plastic Surgery/
General Hospital		 6-488 Complete ASTM F1671/F1671M-22 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
05/29/2023 General Plastic Surgery/
General Hospital		 6-496 Partial ASTM F739-20 Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
 
 
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