Software Test Report including IEC 62304 classification

[Szaki87]

Hi Guys!

Our NB (SGS) recommended as per "shall" to include the IEC 62304 classification of the software running on/in our instruments into the release test reports. I have never heard about it that the Verification/Release Test Report shall contain a statement that the software is Class B (In our case the software is Class B according to IEC 62304). The IEC 62304 regulates the entire SW development cycle why the SW test report shall contain this information only?


I have googled here on elsmar but no found any related topic. Have anybody heard about this "issue"?

Thanks in advance,

Attila

 

[yodon]

Re: Software Test Report including IEC 62304 classification?

Never heard of requiring it in the test report. Doesn't seem like any added value.

We generally have a Software Development Plan where we establish the software class. As you note, the software class drives the entire process so the Plan is structured around the class - including the V&V activities. We reference the Plan in our V&V documentation so that provides linkage back to the software class.

 

[Marcelo]

Re: Software Test Report including IEC 62304 classification?

What "shall" he?s talking about? Is it about the clauses which define requirements for test record contents such as 5.7.5? If so, he?s misreading the standard, because, although there?s a "shall" and a [Class B, C] at the end, this [Class B, C] does not mean that it?s a part of the shall.

There?s no requirement to include the classification
in test reports.

As mentioned by Yodon, the Plan is the place where the classification is expected to be (although even this is not clear on the standard as a requirement).

 

[J0anne]

Re: Software Test Report including IEC 62304 classification?

Hello Attila. I don't think it's an issue either.
Ask your NB to clarify the requirement and its source.
There is a requirement to document the software safety classification in the risk management file. 4.3.c.

 

[Szaki87]

Re: Software Test Report including IEC 62304 classification?

Thanks to All the comments and information!

I have made a simple Software levelclassification section into the Test report template. Hopefully this will meet the criteria on the next year audit

This comment from the Auditor was not a CAR, he highly recommended to include to the next audit

Thanks!