IEC 62366:2015 Annex C - changed parts from 5.1-5.8 --> but what about 5.9?

Tobias_HF

Involved In Discussions
Good morning,
I have a peculiar question: when I read the Annex C about UOUP (legacy products), it basically says that changed parts of the UOUP are no longer UOUP and need to be developed / documented following the UE process from 5.1 to 5.8

Okay, fine so far. But what about 5.9 (Perform summative evaluations)? I am confused why 5.9 is not mentioned - for me it is a very important part of the process, regardless if it is a new product or UOUP.

I am going to do it anyway, I just have doubts if it is explicitly wanted by the standard or not. In case I need to argue budgets, it sometimes helps to point to the standard...
Thx
T.
 

yodon

Leader
Super Moderator
Just speculating since I can't get inside the heads of the standards writers but since the legacy product has presumably been in the field for some time, there should already be feedback on whether or not the UI can be used safely.
 

Pads38

Moderator
Clauses 5.1 - 5.8 cover the design and development of the User Interface.
So this is the process to use for any new design (or new part of an existing design).

It is these parts of the process that cannot sensibly be achieved for a legacy product - hence the Annex C process.

Summative Evaluation is the overall validation of the User Interface and should be performed on both legacy and new designs.
 

Tobias_HF

Involved In Discussions
Summative Evaluation is the overall validation of the User Interface and should be performed on both legacy and new designs.

Yes, but why does it than say that for changed parts of legacy products the steps 5.1-5.8 have to be done, but 5.9, which is the summative evaluation, is NOT mentioned in Annex C?

Just think about if I point to the standard in the next management meeting, and they read this carefully and ask me exactly this question? if you stick to the letters, I`ll have to explain why 5.9 is not mentioned.
 
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