BS EN 62304 - Medical-Relevant Data C.5 - Definition of

DanMann

Starting to get Involved
#1
Does anyone have a definition of "Medical-Relevant Data" as it is used in BS EN 62304?
C.5 of BS EN 62304 says that IVDs that provide "Medical-Relevant Data" and where the software can impact the "Medical-Relevant Data" must follow IEC 62304, but otherwise it is not mandatory (unless I' misreading it).
My company makes instruments for pathology labs to process tissue samples, so no data is provided by the instruments, but the instruments can process the samples poorly and so lead to mis-diagnosis through incorrect performance of the software that runs the instruments.
 
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yodon

Staff member
Super Moderator
#2
I don't have the BS EN version but my :2015 version doesn't have that language. Can you provide a snippet? My version (where I believe this discussion originates around - correct me if I'm wrong) says:

...(if) failure caused by the software which results in an unwanted change of medical data (measuring results), IEC 62304 must be taken into account.

I believe what they're intending is that if the software contributes to the (in your case) possibility of mis-diagnosis, you should apply 62304.
 

DanMann

Starting to get Involved
#4
In BS EN 62304:2006+A1:2015 Annex C.5 (Relationship to IEC 61010-1) says "If laboratory equipment is used as IVD equipment, the measured results obtained must be evaluated in accordance with medical criteria. The application of ISO 14971 is required for risk management. If such products also contain software that can lead to a hazardous situation, for example failure caused by the software which results in an unwanted change of medical data (measuring results), IEC 62304 must be taken into account. " However, the instruments don't provide any medical data, they only process the tissue samples for analysis by a clinician.

There's a flow chart underneath within this section; the only path leading to the use of 62304 is:
Identify known and foreseeable risks.
Is the hazard covered by relevant safety standards? If No:
Does the device provide medical-relevant data? If No, no route leads to 62304. If yes:
Use ISO 14971 for risk management
Does software have impact on the medical data? If No, no route leads to 62304. If yes:
Use of procedures to verify the data? If Yes, no route leads to 62304. If no:
Use IEC 62304.

My argument would be that the instruments don't provide any medical-relevant data (so 62304 does not apply), but I was hoping there was a definition of the term somewhere so I could ensure my understanding of this term.
 

yodon

Staff member
Super Moderator
#5
Compliance to standards is always voluntary. Are you looking for a way to not have to comply with 62304? Is there anything you feel is particularly onerous with the standard? If you conclude that there can be no harm from your software then it falls into Class A which is a pretty lightweight process.
 

Tidge

Involved In Discussions
#6
May I challenge one of the statements?

However, the instruments don't provide any medical data, they only process the tissue samples for analysis by a clinician."
It is conceivable that the mis-processing of the samples could require that another sample be acquired, or that treatment is delayed. There is a spectrum of different harms that accompany 'acquisition of tissue samples', including nasal swabs, lumpectomy, spinal tap. The manufacturer will have to decide the scale of the severity of the potential harms; some may go to eleven. (sorry, I couldn't resist).
 
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