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  • 1.  IVD Instrument - electrical safety

    This message was posted by a user wishing to remain anonymous
    Posted 17-Feb-2022 16:00
    This message was posted by a user wishing to remain anonymous

    Hi All,

    I have a query regarding the minimum requirements in terms of electrical safety testing for placing an IVD Instrument on both the European and Australian Markets.

    We want to avoid the need for a 3rd party certification for any such testing.

    I understand there is a harmonised standard under the IVDD -

    EN 61010-2-101:2002: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment

    but is this overkill? This is a low risk instrument (class 1 in Australia and soon to be class A in the EU under the IVDR). Is IEC60601 and IEC60601-1-2 sufficient? (not sure if the require a 3rd party certificate?)

    Thanks



  • 2.  RE: IVD Instrument - electrical safety

    Posted 18-Feb-2022 08:50
    Hello Anon,

    I guess my first comment is IEC 60601 is not appropriate for IVD medical devices/IVD instruments because this standard is applicable for products which are used with/on patients - not IVD instruments.  IEC 61010 is the appropriate electrical safety standard used for IVD instruments/laboratory equipment.  Using one or the other does not make it 'overkill' or easier as depending on the device/product would apply the applicable requirements from the standard.  As a note, you can do this internally for compliance to the standard, but usually it has more support being done by a third party (independence).

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: IVD Instrument - electrical safety

    Posted 18-Feb-2022 15:24
    Hello Anon,
    In addition to what Richard already stated... There is the base standard IEC 61010-1 which provides the general requirements. IEC 61010-2-101 adds the requirements particular to IVD equipment. There are other particular standards that might also apply depending on what your device does, e.g. IEC 61010-2-010 would be applicable if the device heats materials.
    There are also specific EMC standards for IVD equipment, namely IEC 62366-1 and IEC 62366-2-101.


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    Patricia Taige RAC
    Regulatory Affairs Manager
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    Original Message


  • 4.  RE: IVD Instrument - electrical safety

    Posted 20-Feb-2022 02:46
    Edited by Erik Vollebregt 20-Feb-2022 02:54
    The IVDR risk class says something about the risk related to the intended purpose of the device, not about its electrical safety risk profile. A low risk IVD device may have potentially high electrical safety risks for the user or even for other persons, so you're stuck with having to meet IVDR GSPRs on that point.

    I usally propose clients a thought experiment if they say specific safety design rules are overkill: would you put that statement in your marketing material or have management mention it in a press release launching the device? If not, it's probably less overkill than you make it out to be.

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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 5.  RE: IVD Instrument - electrical safety

    This message was posted by a user wishing to remain anonymous
    Posted 21-Feb-2022 12:42
    This message was posted by a user wishing to remain anonymous

    Thanks everyone for your input,

    as a follow up, are there any pertinent standards or guidelines that can be utilised for mechanical safety testing of an IVD instrument? Or is this covered by risk analysis and risk control verification?

    Thanks
    Original Message


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