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  • 1.  Bio-compatibility tests for active implantable medical devices

    Posted 20-Sep-2021 01:13
    Hi,

    Please let me know when to do the biocompatibility tests for the active implantable medical devices, is it prior to sterilization process or after.

    Regards,
    Jayaram

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    Jayaram Abimanyu
    Chennai
    India
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  • 2.  RE: Bio-compatibility tests for active implantable medical devices

    Posted 20-Sep-2021 02:35
    Hi Jayaram, 

    Per ISO 10993-1:
    That essentially means, the tests have to be done after sterilizing your device. 

    Hope this helps. 

    Regards

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    Sathya T N
    Regulatory Toxicologist
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    Original Message


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