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ANSI/AAMI ST98:2022
Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
This standard covers the requirements to validate cleaning processes that are developed by the medical device manufacturer for processing medical devices. This document applies to all medical devices that require cleaning prior to each clinical use of that device. Clinical uses may be in health care facilities, home uses, or use by first responders, etc.
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Association for the Advancement of Medical Instrumentation [aami]
