Yes. And the physical separation makes this easier to identify. You do have to consider the effects of what the PC can do through operator misuse and technical failures. As examples, can the user select incompatible options or select harmful configuration values?Is it still possible to claim that the software items present in them are segregated enough to give them separate classification?
Secondly, the potential harm presented to the patient by the software is ultimately mitigated by user instructions. Is that a valid "risk control" to use for down grading the classification from a grade B to a grade A?
If the
RISK of death or SERIOUS INJURY arising from a software failure is subsequently reduced to an acceptable level (as defined by ISO 14971) by a hardware RISK CONTROL measure, either by reducing the consequences of the failure or by reducing the probability of death or SERIOUS INJURY arising from that failure, the software safety classification may be reduced from C to B; and if the RISK of non-SERIOUS INJURY arising from a software failure is similarly reduced to an acceptable level by a hardware RISK CONTROL measure, the software safety classification may be reduced from B to A.
The RISK CONTROL measures can be implemented in hardware, software, the working environment or user instruction.
which makes me wonder if implementing user instructions as mitigating factor against a possible risk would count towards software classification reduction, or can that only be done through hardware?[/LEFT]
In my opinion a default classification would not be possible. Every database is used for a specific intended use and different possible effects on patients and users. Classifications range from no medical device to class C.Thirdly, is there a "default" safety classification for medical databases? I have not been able to find any references to such but figured that here would be the place to ask.
which reduces the possibility on injury and possibly the safety class