I need to make test reports according IEC 62304 & IEC 62366

[Talichek]

Hi all.
I'm new to MDD and still learning. Need to confirm some of my thoughts.
I need to make test reports according iec 62304 & 62366
i have 2 questions about it

1. IEC 62304:2006/AMD1:2015 May i apply the test report according the 2008 edition?

2. IEC 62366-1:2015 as much as i understand it's basically the same as the first edition with the change of the second part of the standard as approved by FDA as 62366-2, or the standard itself comes with changes that effect on the test report?

on both cases my game plan is rely on earlier editions as a base of my work, as no changes was made on the devices, so accordingly, my presumption is that the test reports don't have to change a lot or even at all as the amendments on both of the standards unrelated to them directly

Gladly will get some thoughts or guidance form more experienced users))

 

[SK13485]

I'm sorry, I wish I could be of help...

Bump...Anyone ???

 

[yodon]

1. IEC 62304:2006/AMD1:2015 May i apply the test report according the 2008 edition?

I'm unsure what you mean by the 2008 edition. Can you explain? 62304 requires software system testing for class B and C. As stated, it's fairly vague other than you have to show that all software requirements are met. There is no requirement for a test report although that's one method to fulfill part of the requirements for the software system test record contents (5.7.5).

If the software was not developed in accordance with 62304, the :2015 amendment includes a provision for dealing with such 'legacy' code. That tack has you do a gap analysis and determine subsequent actions (based on risk).

Note that this does not consider any unit testing done or integration testing. Those are different issues and I presume not what you meant with your post.

2. IEC 62366-1:2015 as much as i understand it's basically the same as the first edition with the change of the second part of the standard as approved by FDA as 62366-2, or the standard itself comes with changes that effect on the test report?

I can't say what the previous version of 62366 required. the -2 document, though, is the guidance on application of -1. So I'm again a little lost on what the question is. 62366, in general, requires a UE plan that defines what you will do for formative and summative testing (and then, of course, executing to the plan).

on both cases my game plan is rely on earlier editions as a base of my work, as no changes was made on the devices, so accordingly, my presumption is that the test reports don't have to change a lot or even at all as the amendments on both of the standards unrelated to them directly

Relying on less-than-latest revisions can trigger findings. If the old revision is no longer recognized / harmonized, you may not be compliant with the applicable regulations. You should do a gap analysis between what was done and what the current standard is and then determine if there are actions required to close the gaps.

Gladly will get some thoughts or guidance form more experienced users))

Hope that helps some!