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About This Item

 

Full Description

This standard establishes requirements and guidance for selection of the appropriate sterility assurance level for terminally sterilized medical devices and acceptance criteria for maximum contamination rate of aseptically filled products.
 

Document History

  1. AAMI ST67:2019


    Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"

    • Most Recent
  2. AAMI ST67:2011/(R)2017


    Sterilization of Health Care Products--Requirements for Products Labeled 'STERILE'

    • Historical Version
  3. AAMI ST67:2003/(R)2008

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    Sterilization of Health Care Products--Requirements for Products Labeled "STERILE"

    • Historical Version