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  • 1.  Sterility failure

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jan-2018 10:03
    This message was posted by a user wishing to remain anonymous

    ​Needed guidance what needs to be done in the event of a single unit failure in sterility testing of Class II medical device sterilised by Gamma radiation ,where sterilisation is contracted  .


  • 2.  RE: Sterility failure

    Posted 17-Jan-2018 08:26

    Please reference the ANSI/AAMI/ISO 11137 series of standards that were used to validate the sterilization process.   The standards define how to handle a single positive on a dose audit.

     

    Best regards,

    Beverly G. Whitaker

    Indigo Consulting Group, LLC

    32 Dolphin Point Drive

    Beaufort, SC  29907

    843-524-1290 – office

    843-524-1390 – fax

    843-812-1905 - cellular

     

    http://indigoconsultinggroupllc.com

     

    Confidential Correspondence to the intended recipient(s) only. If you are not the intended recipient of this message, or if this message has been addressed to you in error, please immediately alert the sender by reply e-mail and then delete this message and its attachments

     




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