View Full Version : FDA Electrical Standards

Michael Wallace
11-15-1994, 02:19 PM
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