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Confusing Private Users with Electrical Labelling - why change to 11608-4 standard?

  • 1.  Confusing Private Users with Electrical Labelling - why change to 11608-4 standard?

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2023 11:19
    This message was posted by a user wishing to remain anonymous

    With electrical safety and electromagnetic compatibility labelling, teams always attempt to disagree with the standard requirement claiming patients won't understand this type of labelling. In 11608-4:2007, the standard even had the following:
    12.2.2 It is not in the line of IEC 60601-1 to place a symbol for either type B, or type BF or type CF on a peninjector, as this symbol could confuse the private user of the pen-injector (the user does not need to know about the IEC 60601-1 standard). It is probably in line with IEC 60601-1 to classify a pen-injector in its documentation as "internally powered" (no symbol for this on the pen-injector).
    If the pen-injector is part of a system, the relevant symbol (B, BF or CF) shall be placed on the pen-injector according to IEC 60601-1-1. In this situation, the importance of the IEC 60601-1-1 compensates for the disadvantage that the private user gets confused by a symbol.

    However, I notice that the 2022 version of this standard (ISO 11608-4:2022) has no mention of this language. Nowhere that I can find (in the BS editio). Was it removed? Does anyone know why?


  • 2.  RE: Confusing Private Users with Electrical Labelling - why change to 11608-4 standard?

    This message was posted by a user wishing to remain anonymous
    Posted 30-Jan-2023 08:15
    This message was posted by a user wishing to remain anonymous

    Unusual verbiage for a standard. Maybe general cleanup???

    https://www.confinis.com/confinis/iso-fdis-11608/