Software requirements and X-ray devices

A

alexander73

#1
I'm seeking any standard (international, national) connected both with software and X-ray equipment for angiography and surgery. IEC, EN, UL, NEMA etc. I've looked through loads of literature and found something. For example, IEC 60601-2-43 "Medical electrical equipment. Particular requirements for the safety of X-ray equipment for interventional procedures". But I haven't found any trace of software requirements (operation system, database, instruments, time limits, methods). Does anybody know about it?
 
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M

MIREGMGR

#2
I'm not aware of rules or guidances other than the generally applicable task-specific validation requirements.

We know from observation of the regulatory troubles of various notable diagnostic imaging companies, though, that...at least on the FDA side...those validation requirements can be interpreted rigorously in the case of software for radiation systems.
 
Q

QMS eager - 2010

#3
I´m not working within the field of x-rays, although medical images (MRI).

We have used:
IEC 62304 Medical Device Software - Software life-cycle processes

I guess you will have to classify your software to a higher class than we do due to the x-rays.

IEC 62304 requires you to classify your software (or parts of the software) to Class A,B,C which all requires different paragraphs to comply with the standard.

Good luck!
 
J

Juan Dude

#4
I'm seeking any standard (international, national) connected both with software and X-ray equipment
You may have a hard time finding information that addresses both software and x-ray equipment, so why not approach the issue as 2 separate sub-systems that function together in one system, i.e. there is plenty on information of software validation and there may be plenty of information on x-ray equipment (I don't really know tho).

Just a thought, I may be wrong tho.

Best regards.
 
A

alexander73

#5
Thanks to all
but guys, I mean the following. I studied individual standards around x-ray equipment and medical software taken separately. But for the time being we faced with the dilemma should we use real-time OS or Windows NT is ok, what kind of hardware redundancy we should have, and other stuff like that. When we developed fluorograph it was obvious that software isn't critical component so we applied standard 62304 approach and risk management. Now we're puzzled 'cause continuous roentgenoscopy guaranteeing and rigirous device control during surgical procedure isn't not the same that simple picture grabbing and showing. So I'm absolutely sure it's a question of particular standard (if it exists).
 
M

MIREGMGR

#6
I think your original question was clear. If such a task-specific functional standard, rule or guidance exists, I'm not aware of it.
 
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