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  • 1.  CB certification and testing facilities

    This message was posted by a user wishing to remain anonymous
    Posted 23-Sep-2022 09:04
    This message was posted by a user wishing to remain anonymous

    Hi ,

    Is it necessary to have CB certification for medical (electrical) devices? Are there any such testing facilities in Australia ?

    thanks


  • 2.  RE: CB certification and testing facilities

    Posted 23-Sep-2022 12:18
    Hi Anon,

    Do you address the IEC 60601 series? 

    My personal understanding is, that a CB test report for IEC 6061-x  is advisable if you go international, but not mandatory. 

    If you look for an CB test house, you may check the IECEE list (https://www.iecee.org/dyn/www/f?p=106:42:0)

    ------------------------------
    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


  • 3.  RE: CB certification and testing facilities

    Posted 24-Sep-2022 11:12
    There are a couple of regulatory submissions that may require CB certificates and test reports but otherwise there is no regulatory requirements out there that force you to do so.  I believe (but you should verify) that it is Israel & Korea.  Realize that most good test labs will issue a test report that is based on a CB test report without the certificate anyway, like Uwe said.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------

    Original Message


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