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  • 1.  Extractables and Leachables

    This message was posted by a user wishing to remain anonymous
    Posted 03-Sep-2019 09:54
    This message was posted by a user wishing to remain anonymous

    Hi

    Can you please tell me if there are any guidelines of Extractables and Leachables that would provide you with a cut off limit?

    Thank you
    Sara


  • 2.  RE: Extractables and Leachables

    Posted 04-Sep-2019 00:35
    Sara,

    Start with ISO 10993-17 which provides a risk management model for estimation of safe limits. 

    The ISO committee is currently working on expanding this to more fully embrace Thresholds of Toxicological Concern - drawing on ICH M7 guidance.

    Arthur

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    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
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  • 3.  RE: Extractables and Leachables

    Posted 04-Sep-2019 01:44
    Hi Sara,

    There is also the ISO TS 21726 2019 Biological Evaluation of medical Devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituent, which I think it might help you.

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    Spyros Drivelos
    Medical Devices Manager
    Agia Paraskevi, Athens
    Greece
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