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ANSI/AAMI ST90:2017

Processing of health care products - Quality management systems for processing in health care facilities

This document specifies minimum requirements for quality management systems (QMSs) to effectively, efficiently, and consistently process (transport, clean, decontaminate, disinfect, inspect, package, sterilize, and store) medical devices to prevent adverse patient events and nonmanufacturer-related device failures.

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Association for the Advancement of Medical Instrumentation [aami]

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