Usability Engineering ISO 62366:2008 - Medical Devices

F

frivolas

Hi all,

Thanks everybody for such a good collection of replies and documents. I just recently became the usability engineer of our team and it's been quite a challenge to understand everything that has to be done to comply with the regulations and develop sound products. If I might, here are my $0.02

Usability testing or engineering does not only refer to filling out a template, you HAVE TO test your device. Allow me to insist. If not for pure regulatory compliance, do it to demonstrate your professional ethics and values. All the products being designed here have the potential to hurt somebody, let's make sure they don't. Besides, it's really fun and interesting to put your product out in people's hands and learn how they interact with it. Always so many surprises.

To know how to run a usability test, reading the 62366 is not the best source, IMHO the standard actually doesn't help at all to learn how to run a usability test. There's just so much to running one (or several, depending how many your device's development process needs) of those tests.

There's a couple of FDA guidelines and presentations that do a good job explaining it and also a bunch of books. I've found the one written by Wilkund and the one by Rubin (already mentioned) to be the best ones out there. Read them and you'll have at least one foot on the right path.

I was really lost on how to actually document the UE File, but thanks to all of you who so kindly uploaded your samples. I wish the annex H had a little bit more explanation to it (or a better format), but mostly everything got cleared up when I read annex A. If you're still confused about what everything means, go read annex A.

I'll now go and write my own version of the UE File for my products, and add it to our product history file (where our risk management file lives). I hope this will put us in line with the FDA requirements.

Cheers!
 
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F

frivolas

JWG 4 (JWG 3 in ISO) is somewhat late in the revision of 62366... SO we will problably hae the standard in the beginning of 2014 if everything is ok.

Hi Marcelo!

So now that we're almost in March '14, would you be able to give us an update on the progress of this revision?

Thanks!
 
M

mr.mike

Question regarding validation:

It seems that usability validation is a large part of the product design validation.

As such, would it not be recommended to have a single design validation plan that encompasses usability aspects?

In otherwords, rather than having two separate plans and reports, is it not more efficient to do both in a single study?
 

Ronen E

Problem Solver
Staff member
Moderator
Question regarding validation:

It seems that usability validation is a large part of the product design validation.

As such, would it not be recommended to have a single design validation plan that encompasses usability aspects?

In otherwords, rather than having two separate plans and reports, is it not more efficient to do both in a single study?
In most cases, yes.

Cheers,
Ronen.
 

Sheemah

Starting to get Involved
Hi!

Great work!

My brazil UL project engineer is asking us to comply with the usability clause of IEC 62366:2007 +Am1:2014 along with iec 60601-1-6, and User Interface of Unknown Provenance (SOUP), i believe that SOUP is for software, but in our case the software is of minor level of concern, in that case do i still need to apply IEC 62366? And as far as the usability is concerned of the device can be used easily and does not have much risk, is there way not comply with standard??

Thanks,
Sheemah
 

Marcelo

Inactive Registered Visitor
User Interface of Unknown Provenance is UOUP, not SOUP. SOUP is for software.

If you are talking about the INMETRO certification process, standards are mandatory here, there's no way to not comply.
 
R

raj2017

Hello Laura and welcome to the Cove!

May be the Usability Engineering File completely part of other technical files (e.g. the Requirement Summary) or is it important to hold a traceability of the process into another external file?

The usability engineering file, as the definition posted by Sagai says, is the place to hold all usability engineering process documentation. Although the contents may form part of other documents, it´s important that you do have a document called usability engineering file. It will help, for example, in assessing conformity to IEC 62366 if needed.

Also, the requirement summary has nothing to do with the usability engineering file or process (although you should have usability requirements in the requirement summary :)).

REgarding IEC 62366 and IEC 60601-1-6, please take a look at the following thread: IEC 62366 vs. IEC 60601-1-6 - Has IEC 62366 now replaced IEC 60601-1-6?[/URL]
Can you please share an example usability engineering file for reference. Thanks.
 
K

Karen747

Hi,

I was wondering if anyone could help me with how to incorporate ISO 62366 into legacy products files, more specifically IVDs. Can you put it into your RMF or does one need a separate file?

Is there any guidance document available for IVDs ( very new to reg and would really appreciate the help).

Thanks in advance :)
 
IEC 62366-2015 has a process for dealing with legacy products at Annex C.

These are referred to as 'UOUP' - that is User Interface Of Unknown Providence.

This version is not yet listed as 'harmonised' by the EU. However, I have successfully used it several times as one of my list of standards applied, and this approach has been accepted by our NB.

I have found it most satisfactory to show the process of Annex C by creating a separate, standalone document that I call a 'Usability Engineering File.' Having a separate document avoids having to explain your process to your NB (or other regulatory authority).
 
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