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  • 1.  IEC 60601-1 Relationship with Collateral Standards

    This message was posted by a user wishing to remain anonymous
    Posted 22-Oct-2020 16:43
    This message was posted by a user wishing to remain anonymous

    Hi everyone,
    I am working on my device labeling (a small electronic medical device) and one of the IEC 60601-1 collateral standards has a requirement to put certain information on the enclosure of the ME equipment. There is no exclusion in the collateral, so basically the requirement is that the information is on the enclosure, period (not on the packaging or user manual).

    The general standard does have a general exclusion in regards to placement of the information on labeling in subclause 7.2: that if the device is small then you can place information on the packaging and/or other labeling (unless it's in certain subclauses of 7.2; but this information is not one of those mandatory to be on the device itself in the general standard so we are including it in our user manual).

    Does the exclusion of the general standard apply to the collateral too?
    OR, since the collateral standard does not have its own exclusion for where to place the information, is it mandatory to have the collateral information on the device itself (i.e. the enclosure)?

    Thank you!


  • 2.  RE: IEC 60601-1 Relationship with Collateral Standards

    This message was posted by a user wishing to remain anonymous
    Posted 23-Oct-2020 10:00
    This message was posted by a user wishing to remain anonymous

    Hi,
       Just from the size/dimensions and power requirement alone i would surmise this would be a low powered device which does not have a charger.
    60601 covers many facets of ESD, Protection from Shock and Insulation. Would this device inherently increase the voltage(photomultipliers, voltage doubler arrays) or current that would increase the risk for the usage which needs specific labelling - as far as input energy is safe for use but the working principle uses far higher current/energy- to include labelling. Justifiably you could put a Hazard Label indicating the possible harm that could arise by the working principle.



  • 3.  RE: IEC 60601-1 Relationship with Collateral Standards

    Posted 23-Oct-2020 15:35
    1) You are not clear what collateral standard and what specific clause.  So, hard to say.  Too broad to answer a question like that.
    2) Are you referring to the EM Disturbances Standard IEC 60601-1-2.  Make sure you are clear what version of the standard you are relying on.  If another collateral standard it is important to be clear about this issue.  If different collateral than the country you are getting your regulatory approval from may have impact as well.

    ------------------------------
    Leonard (Leo) Eisner, P.E.
    The "IEC 60601 Guy"
    Principal Consultant, Eisner Safety Consultants
    Phone: (503) 244-6151
    Mobile: (503) 709-8328
    Email: Leo@EisnerSafety.com
    Website: www.EisnerSafety.com
    ------------------------------



  • 4.  RE: IEC 60601-1 Relationship with Collateral Standards

    This message was posted by a user wishing to remain anonymous
    Posted 03-Dec-2020 08:48
    This message was posted by a user wishing to remain anonymous

    Hi, thanks for your response!
    To answer your questions: the collateral I'm referring to is 60601-1-11:2020 (consolidated version), clause 7.2 (Additional requirements for marking of IP classification).
    While clause 7.2 of the general standard allows us not to put this information on the device because it's very small, the -1-11 collateral seems to require this without an exclusion. Does that mean we have to put this on the device itself in order to comply with this collateral, or does the exclusion in the general standard act like a "blanket" exclusion that applies to the -1-11 collateral too?

    Thank you.


  • 5.  RE: IEC 60601-1 Relationship with Collateral Standards

    This message was posted by a user wishing to remain anonymous
    Posted 23-Oct-2020 16:35
    This message was posted by a user wishing to remain anonymous

    Hopefully @Leonard Eisner can provide you with a direction to look into.​