What do you think the revision of IEC 62366 should bring?

https://elsmar.com/Forums/showthread.php?t=31712&page=2

Post number 14

Thanks, Pads38

Marcelo Antunes said:

......(I'm creating an usability engineering template that addresses all aspects required by the standard and will share here in the conve when finished).

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Hi Marcelo,
How did you get on creating your "usability engineering template". I'm very much looking forward to it.

levissima said:

Hi Marcelo,
How did you get on creating your "usability engineering template". I'm very much looking forward to it.

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Hi Marcelo,

I think a lot of people (me included!) would be benefited from having a template of the required documentation and its contents made by someone with as much experience as you.

We'd really appreciate if you could give us some news on how it's preparation is going.

To answer your question, I'd like to also see comprehensive examples. Or at least a good and clear explanation of what the standard expects regarding the process, documents and their contents:

• An example or description of how the usability verification and validation plan should be presented, as right now I'm really just creating a plan similar to what I've done for other type of projects.
  
• A better example of the user profile and the use scenario description. It is so vague right now that it barely says anything. And I know that I could go and write a bible about my users and the expected scenarios and that's not practical. But I don't want to over simplify it as shown in the current examples and then miss something.
  
• It mentions that the manufacturer should specify the verification criteria, and then it goes explaining what a usability goal is, when usability goals are not accepted by the FDA. Maybe providing more examples of how to formulate such criteria will help.

Thanks a lot!
Oscar

The standards below can be of some help on how to do good human factors engineering, if this can help.


ANSI/AAMI HE75, 2009/(R)2013 Human factors engineering?Design of medical devices

Marcelo, Did you ever get a template done that includes all aspects of A.1? I sure would be interested in seeing one...

No, I didn not, sorry! And now that IEC 62366-1 is out, it would be better to make one on that. But I?m not sure if I will manage to do it (at least, not anytime soon).