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Full Sterilisation Validation for Novel Devices

Discussion in 'US Medical Device Regulations' started by Jo Campbell, Feb 10, 2016.

  1. Jo Campbell

    Jo Campbell Member

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    Hi All,

    In relation to FDA requirements, where in any regulations or standards does it state that for novel products you must perform a full method C sterilisation validation for EtO, and cannot validate via the adoption method?

    Regards,

    Jo
     
  2. Vintage Goose

    Vintage Goose Active Member

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    Hi, unfortunately I don't have access to the latest standards, but I would take a look at AAMI TIR 28 (Product adoption and process equivalence for ethylene oxide sterilization). This may be of help.
    Chris
     
  3. Jo Campbell

    Jo Campbell Member

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    Thank you Chris, but I have a copy of AAMI TIR 28 and can't find anything that states you need to perform a full EtO sterilisation validation for a novel device, unless I've missed it or it's written in a way I can't understand.
     

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