Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

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AAMI

Reference83 articles.

1. ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. Association for the Advancement of Medical Instrumentation Arlington VA; 2012.

2. ISO 11139:2018 Sterilization of health care products—Vocabulary of terms used in sterilization and related equipment and process standards. Geneva 2018.

3. ANSI/AAMI/ISO 14161:2009/(R)2014 Sterilization of health care products—Biological indicators—Guidance for the selection use and interpretation of results. Association for the Advancement of Medical Instrumentation Arlington VA; 2014.

4. ANSI/AAMI/ISO 15882:2008/(R)2013 Sterilization of health care products—Chemical indicators—Guidance for selection use and interpretation of results. Association for the Advancement of Medical Instrumentation Arlington VA; 2008.

5. Chemical disinfection and antisepsis in the hospital;Spaulding EH;J Hosp Res,1972

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