| Where to start: discussing with a notified body? Hello all:
At the moment is seems not so easy to have the CE 14143 changed that it allows mCCR's.
But it is also clear that a unit does not have to meet all the requirements, and still get a CE rating, if it does not concern a life-critical item.
So it depends on the notified body that goes over the technical file, and wether or not it finds the file to comply with the standard or not.
so it seems that an easier way to get mCCR's CE rated, would be starting a discussing with a notified body, and convince them that the unique properties of the mCCR's, wich make them impossible to meet certain criteria, are not life-critical, but just have an improved safety.
criteria that are not met by mCCR's:
mCCR's do not automaticallly maintain a breatheble PPO2: they will fail the test on the breathing machine both hypoxic and hyperoxic
all other tests in CE can be applied to both eCCR and mCCR
so to what notified body, who, can this discussion be adressed to?
paul
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