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ANSI/AAMI/ST81:2004 (R2016)

Sterilization of Medical Devices - Information to be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices

This standard 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.

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Association for the Advancement of Medical Instrumentation [aami]

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