Medical Electrical Equipment & UL approval
I was wondering if anyone had any experience with electrically powered medical equipment and gaining UL approval.
The safety aspects are covered by the various sections of 60601. This particular tool, has some control logic connected to the trigger that controls the operation of the tool.
Because the tool now incorporates sofware, UL require us to ensure that this element complies with 60601-1-4.
If anyone is familiar with this, how did you interpret the life-cycle diagram, so that you could produce a plan that meets their requirements?
p.s. I'm sorry if this message is "off-topic" because it is not strictly 13485.
Many thanks,
I was wondering if anyone had any experience with electrically powered medical equipment and gaining UL approval.
The safety aspects are covered by the various sections of 60601. This particular tool, has some control logic connected to the trigger that controls the operation of the tool.
Because the tool now incorporates sofware, UL require us to ensure that this element complies with 60601-1-4.
If anyone is familiar with this, how did you interpret the life-cycle diagram, so that you could produce a plan that meets their requirements?
p.s. I'm sorry if this message is "off-topic" because it is not strictly 13485.
Many thanks,