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FDA Electrical Standards

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  • FDA Electrical Standards

    I am a Master's Student at the University of California, Davis. My
    thesis involves making measurments using a load cell system during anterior
    cruciate ligament reconstructive surgery (knee) in the operating room theater.

    I was told that FDA standards exist for any electrical equipment used in the
    operating room which specify; the allowable leakage rates as well as
    special 'saftey circuits" preventing to much current being passed to the
    patient if the equipment were to become faulty.

    Does anyone know what these specifications and/or what this FDA
    documentation is called. In addition our orthopedic group here at Davis
    is concidering implanting an electro-mechanical device in the knee. What
    type of electrical stardards should this person be concerned with.

    Thank you for your help

    Michael Wallace
    (916) 752-2713