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View Full Version : UL Approval for Medical Products


mmgbmm
23rd August 2007, 06:21 PM
Hi, :bigwave:

I have a medical product (fetal monitor), which has an isolated transducers. We had to redesign one of the PCBs inside the unit. In the new design we kept the same isolation gaps between the isolated and non-isolated sections.
Do we have to go through new UL approval exercise? Or it is not required as the isolation circuitry has not changed.

Thank you,
M

Al Rosen
23rd August 2007, 06:46 PM
Hi, :bigwave:

I have a medical product (fetal monitor), which has an isolated transducers. We had to redesign one of the PCBs inside the unit. In the new design we kept the same isolation gaps between the isolated and non-isolated sections.
Do we have to go through new UL approval exercise? Or it is not required as the isolation circuitry has not changed.

Thank you,
MI think that if the change affected anything in the Report, you will have to have the report updated. Usually a small change will not involve much in terms of cost or time.