The 2005 edition has the rationale I mentioned.
Apologies. I was reading the main text and not Annex A. I've found it now...
So, yes, you can have an equipment complying with the standards with only the LOT number, as mentioned.
Apparently the Applied Part symbol is still required regardless...
...but more generally, as is the subject of this thread, is how to
prioritize contents given limited space.
Caveats for limited label space are subjective, and so depending on the requirements of regulator or test-lab, I could easily imagine a situation where a test-lab says "there is space for the required applied part symbol...if you just removed the UDI", or the FCC saying "sure there's space for the FCC ID...it's more important than the Applied Part symbol...".
Sure there is, and I?ve seen it lots of times, you can, for example, put the symbol on the manual next to the specific risk you want to point to.
I guess... but it somehow seems inappropriate to use the "refer to instructions manual/booklet" symbol
IN the instructions manual...
I suppose, when defining the symbol, you'd have to describe what the symbol means on the device label (i.e. "refer to instructions") and what it means in the instructions itself (i.e. "this is a mandatory risk-control action").
Contraindications are not "RISK CONTROL measure for a specific RISK" as this symbols is to be used, they are more general controls in this case.
Hmmm... I'm not sure I'm getting the distinction between risk control for a specific risk versus general controls.
As far as our risk-analysis, we've identified "person with (specific contraindication) using the device" as a potential risk, and the only mitigating measure is to provide a contraindication warning in the instructions. Is this not a specific risk?
More generally, are not all stated warnings tied to risks? Otherwise why would they be stated? ...ah yes, liability...
P.S. thanks for good discussion and enlightening me!
