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  • 1.  60601-1 Applied Parts Vs 60601-1-2 patient Coupling Parts

    This message was posted by a user wishing to remain anonymous
    Posted 07-Apr-2023 08:01
    This message was posted by a user wishing to remain anonymous

    Can Applied Part be == Coupling Part? 
    My understanding is that coupling parts are not necessarily parts that have direct patient contact as applied parts. 
    What is the diff ? 




  • 2.  RE: 60601-1 Applied Parts Vs 60601-1-2 patient Coupling Parts

    Posted 12-Apr-2023 19:39

    Hi Anon

    There's a lot of overlap, but they're not totally equivalent concepts. Not everything that touches a patient is really capable of transferring electromagnetic energy.

    You might try reading the rationales in Annex A of the 60601-1 standard for the definitions of "applied part" and "patient connection". That's reasonably clear about the distinctions. Then re-read the definition in the 60601-1-2 standard of "patient-coupled" and you may get a better feel for the kinds of things that would qualify or not.

    Or maybe someone else can think of some good examples.



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    Anne LeBlanc
    United States
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    Original Message


  • 3.  RE: 60601-1 Applied Parts Vs 60601-1-2 patient Coupling Parts

    Posted 13-Apr-2023 06:44

    Hi,
    No, Applied Part and Coupling Part are not the same thing in the context of medical electrical equipment standards, specifically IEC 60601.

    The Applied Part refers to that part of the medical device that comes in direct contact with the patient's body or is used to transmit energy to the patient's body. Examples of Applied Parts include electrodes, probes, and surgical instruments.

    The Coupling Part, on the other hand, is the part of the medical device that connects the Applied Part to the rest of the equipment. The Coupling Part may include cables, connectors, and other components that are used to transmit energy or signals between the Applied Part and other parts of the medical device.

    In IEC 60601, different requirements and tests apply to Applied Parts and Coupling Parts to ensure the safety of the medical device. For example, there are specific requirements for the insulation and leakage current of Applied Parts to prevent electrical shock to the patient. There are also requirements for the insulation and creepage distances of Coupling Parts to prevent electrical arcing between parts of the medical device.



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    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
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    Original Message


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