UL Approval for Medical Products

M

mmgbmm

#1
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
 
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#2
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
I 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.
 
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