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AAMI ST81:2004/(R)2016

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

Association for the Advancement of Medical Instrumentation , 12/02/2004

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AAMI ST81:2004/(R)2016 PDF

Specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable and medical devices intended to be sterilized by the processor. Requirements are specified for the information to be provided by the medical device manufacturer so that the medical device can be processed safely and will continue to meet its performance specification. This standard also includes definitions, a bibliography and informative annexes.