What is the remedy if Unit level testing is not documented?

S

SteveZed

#11
Hello,

I don't mean to nit-pick, but I'd like to ask just to test my understanding of 62304.

Per IEC62304 class B requirements, unit level testing has to be performed and documented.
I can see "Software Unit Verification" (Section 5.5.5) and Software Integaration and Integration Testing (5.6), but I don't find the term Unit Testing.

My reading of "Veification" is that it can encompass things like design review or code walkthrough. So, strictly speaking, a Unit Test is not required. Only Integration Testing. Am I out to lunch or is this a valid interpretation?

Thanks,
-Steve
 
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S

s_g_robertson

#13
Hello,

I don't mean to nit-pick, but I'd like to ask just to test my understanding of 62304.



I can see "Software Unit Verification" (Section 5.5.5) and Software Integaration and Integration Testing (5.6), but I don't find the term Unit Testing.

My reading of "Veification" is that it can encompass things like design review or code walkthrough. So, strictly speaking, a Unit Test is not required. Only Integration Testing. Am I out to lunch or is this a valid interpretation?

Thanks,
-Steve
5.5.2 says:

Establish SOFTWARE UNIT VERIFICATION PROCESS
The MANUFACTURER shall establish strategies, methods and procedures for verifying each SOFTWARE UNIT.
Where VERIFICATION is done by testing, the test procedures shall be EVALUATED for correctness.
[Class B, C]
So it seems clear to me that testing is only one possible approach for verifying each software unit.

Stephen
 

kreid

Involved In Discussions
#14
Sorry but that is bad advice from Peter with regard to a direct relationship between the MDD classification and the 62304 classifications. Please do not follow this logic.
 
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