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IEC 62304 - 5.2.9 Verify Software Requirement

R

rumplefish

#1
Hi all,

Sorry if this has been asked before, I just didn't seem to find it.

I'm writing an SRS document for a class A medical device according to IEC 62304. I've wrote all the software requirements and I'm stuck in the verification section.

What am I supposed to write there?

Do I write the actual tests for each requirement, or do I just write a short description on how the test will be performed?
 
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yodon

Staff member
Super Moderator
#2
Presume you mean 5.2.6?

If you look at what the standard is addressing for this activity, I believe it's more review-based. Here are snippets from the list:
a) implement parent requirements (including risk mitigations allocated to software) ;
b) aren't contradictory (within);
c) are unambiguous;
d) are verifiable (testable);
e) are uniquely identified; and
f) are traceable to parent specifications.


This is all pretty review-based, IMO. Of course, you need to have things in place like unique identification and a trace back to the parent specifications. If you take a top-down look from the parent (which may be implemented in multiple software requirements), you determine if the sum of software requirements (fully) implement the parent specification. The review would also confirm no contradictions and the ABILITY to verify (through test) the requirement (e.g., having a requirement that the software be "fast" is not verifiable).
 

Marcelo

Inactive Registered Visitor
#4
This is realted to a requirements engineering process, if you use a formal one, you probably is already doing everything the standards is requiring.

If not (which seems to be your case), you need to verify that each requirement fulfills the requirements in 5.2.6.

Itns a and f are the more complicated because they require that you trace the software requirements to the device (system) requirements, including risk control measures implemented by software, so you need to link the software requirements to the device requirements and device risk management.
 
R

rumplefish

#5
Thank you for your replies.

I'm kind of new at this so you'll have to excuse me if I ask stupid questions
:D

So I've wrote all the software/system (I'm not sure that there's any difference in my case) requirements, I went over the risk analysis document and added that to the requirement, and now I have to verify that the requirements are up to the standard.

I don't have any higher level requirements to trace my requirements to, except maybe the risk analysis. Do I need to list the requirements and specify from where they were derived?

Also, I assume we'll do a review on the requirements, does this mean a seperate document?

Sorry:eek:
 
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