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  • 1.  Critical components list - labels

    Posted 29-Jul-2020 05:11
    Dear RAPS members,

    I have a question related to the contents of the IEC 60601-1 Critical components list. Is it required to include labels (e.g, Applied parts) also in the critical components list?

    Appreciate your valuable feedback.

    Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------


  • 2.  RE: Critical components list - labels

    Posted 30-Jul-2020 04:09
    Most test houses will require the critical components list to include the label info, including the agency recognition info if used for labeling or symbols used to meet IEC 60601-1 or other related collaterals in the series of standards.


































































































































































































































































































































    standard (or the applicable sieiiii                                                                       that is required by the standard

    ------------------------------
    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
    ------------------------------

    Original Message


  • 3.  RE: Critical components list - labels

    Posted 30-Jul-2020 04:17
      |   view attached
    Thanks, Leo for your valuable feedback. 
    I also have a question regarding the shape of the label. Is it acceptable to print the Type B applied part symbol in a round-shaped label (see attached picture)?

    Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------

    Original Message


  • 4.  RE: Critical components list - labels

    Posted 30-Jul-2020 15:28
    It is rare to find a Type B Applied Part anymore.  Is the Applied Part actually grounded in some way?  That is usually how you obtain an Type B rating.  Yes, you can use a circle label as long as the B or BF symbol is not in an outline of a circle changing the meaning of the symbol.  It should be the symbol as shown in Table D.1, No. 19 for Type B, No. 20 for Type BF, and No. 21 for Type CF.

    ------------------------------
    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
    ------------------------------

    Original Message


  • 5.  RE: Critical components list - labels

    Posted 31-Jul-2020 03:28
    Thanks Leo!very much appreciated.
    Yes! Non-conductive material is used for applied parts.

    Regards,

    ------------------------------
    Soumya Rajesh
    Quality and Regulatory Affairs Manager
    Den Haag
    Netherlands
    ------------------------------

    Original Message


  • 6.  RE: Critical components list - labels

    Posted 01-Aug-2020 03:06
    Grounded and non-conductive material are not the same thing so would have to evaluate the isolation diagram of the device/system to determine if this makes sense or not.  Not something that can be done thru this forum.  Would be done on a private consultation basis please contact me privately.

    ------------------------------
    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
    ------------------------------

    Original Message


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