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Full Description

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.
 

Document History

  1. AAMI/ISO 17664-1:2022


    Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices

    • Most Recent
  2. AAMI/ISO 17664:2017


    Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

    • Historical Version
  3. AAMI ST81:2004/(R)2016

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

    • Historical Version