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Full Description

The 2013 collection of 38 documents is intended primarily for manufacturers who ship their products sterile. It features new guidance for sterilization of single-use medical devices incorporating materials of animal origins (14160), requirements for products labeled "sterile" (ST67), dry heat sterilization of health care products (20857), radiation (11137-2), and more.
 

Document History

  1. AAMI STBK13-3

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    Sterilization, Part 3: Industrial Process Control, 2013 Edition

    • Most Recent
  2. AAMI STBK10-3


    Sterilization, Part 3: Industrial Process Control, 2010 Edition

    • Historical Version
  3. AAMI STBK06-3


    Sterilization, Part 3: Industrial Process Control, 2006/2007 edition

    • Historical Version