Usability Engineering ISO 62366:2008 - Medical Devices

[Shibukallidukkil]

In Reply to Parent Post by freewind

Hi, I would like to pose another question based on the discussion on this thread.

If I have already implemented a risk management process based on IEC 60601-1:2005 (and IEC 60601-1-6) and ISO14971; and I have considered usability in my risk management process, do I still need to get the IEC 62366 and compile a usability engineering process?

Wouldn't it be an overkill?

Thanks!

Hi,

I too feel it as a overkill,

But as per the latest edition of IEC 60601-1-6, it is mandatory to meet the usability engineering process or in other words product can not be in compliance with 60601-1-6 with out meeting requirements of iec 62366.

but as per you , "you have already implemented a risk management process based on IEC 60601-1:2005 (and IEC 60601-1-6) " but how could you do it without meeting IEC 62366 since 62366 is a part of IEC 62366.

i am also facing problems to make a usability validation document or really i am not able to differentiate between usability verification and usability validation :P

regards

[Ronen E]

In Reply to Parent Post by Shibukallidukkil

Hi,

I too feel it as a overkill,

But as per the latest edition of IEC 60601-1-6, it is mandatory to meet the usability engineering process or in other words product can not be in compliance with 60601-1-6 with out meeting requirements of iec 62366.

but as per you , "you have already implemented a risk management process based on IEC 60601-1:2005 (and IEC 60601-1-6) " but how could you do it without meeting IEC 62366 since 62366 is a part of IEC 62366.

i am also facing problems to make a usability validation document or really i am not able to differentiate between usability verification and usability validation :P

regards

Usability engineering encompasses more than risk management.

To better understand usability validation maybe have a look here:

http://www.fda.gov/downloads/Medical.../UCM259760.pdf

HE75 might also be of help:

http://www.aami.org/publications/standards/he75.html

Cheers,
Ronen.

[Marcelo Antunes]

Just a heads-up, althought the revision of IEC 62336 (creating IEC 62366-1 and IEC 62366-2) will take some years, the amendment I mentioned before to the original IEC 62366 which is the annex detailing how to deal with legacy software will be published in the following months (probably May/June 2013)

[Marcelo Antunes]

Correcting - it's not legacy software that the Annex will deal with, it's legacy devices. Thanks Sabrina for the pointing this error to me!

[S. Costa]

No problem. You're welcome. Thanks a lot for the information Marcelo

[kaan_bugra]

Hello everybody,

I am Gokhan from Turkey. We are manufacturing External Fixators (implants) and it works with a web application (software) . Our Notified Body's want us to perform usability Engineering Study.(a usability procedure, plan and validation etc.) I need some example about this study. Pls share some example with me, if you have.

Thanks

[S. Costa]

Hi Kann bugra,

You need to use the IEC 62366: 2007 which describes how to implement an Usability Engineering process. The following key steps need to be taken (not exhaustive)


1. User research/ conceptual design

- Application Specification
- Frequently used functions
- Identification of hazards and hazardous situations related to usability

2. Requirement and criteria development

- Primary operating functions
Describe primary operating function...
- Usability specification
Describe use scenarios related to the primary operating functions and requirements for determining whether primary operating functions are easily recognizable by the user etc.
- Usability validation plan
Specify any method used for usability validation of the primary operating functions, criteria for determining successful validation of the usability of the primary operating functions...

3. Detailed design and specification

User interface design and implementation
Design and implement the user interface as described in the usability specification

4. Evaluation

- Usability verification
Verify the implementation of the medical device user interface design against the requirements of the usability specification and recorded the results in the usability engineering file.
- Usability validation
Validate usability of the medical device according to the usability validation plan and recorded the results in the usability engineering file.

However, this process implies to use appropriate usability or human factors methods to each step !

The next revision of the standard (IEC 62366) will give some examples...

Cheers !