Louis,
Thanks for the message, I just received it.
I found the CE Risk classifications, and wonder about whether this 'manufacturing classifications' are entirely relevant to PPM scheduling from a risk perspective.
The CE risk classification is looking at the risk to the patient in the event of poor manufacture.
It is not looking at the risk to the patient in the event of not carrying out planned maintenance.
There are CE class III high risk devices such as implanted pacemakers which cannot receive a ppm.
or Class 1 low risk devices such as battery operated monophasic electrotherapy, which can cause electrolytic burns, which do need an annual ppm.
Do you combine the CE classification with some other cross check?
