Usability Engineering ISO 62366:2008 - Medical Devices

W

Watchwait

#1
We manufacture a Class IIa medical device & maintain compliance to 60601-01 2nd edition. We have no intentions of claiming compliance with the 3rd edition of this standard until absolutely necessary & we gave have time in that regard.

However, my question is in regards to 62366 Usability Engineering for medical devices standard. We have a current ISO 13485 certification & ship product to the EU. Our product Technical File has been successfully reviewed by our Notified Body, and we do not reference EN 62366 in the Essential Requirements checklist. We do reference compliance to 60601-01 2nd Edition. Given this, where does conformance to the requirements in 62366 enter our picture, if at all?
 
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M

MIREGMGR

#2
Re: Usability Engineering 62366:2008

When you established conformity to IEC 60601-1 "Medical Electrical Equipment Part 1: General Requirements for Safety" 2nd Edition, did you also establish conformity to IEC 60601-1-6 "Collateral Standard: Usability" 2nd Edition?
 
W

Watchwait

#3
Re: Usability Engineering 62366:2008

....(gulp!)...no & it never came up as an issue. Am I going to h**l in a handbasket?:nope:
 

Marcelo

Inactive Registered Visitor
#4
What you need is to put in place a Usability Engineering Process. These standards, as ISO 14971, are process-based standards, rather than pure safety standards (they are also risk management-based). Complying with IEC 60601-1 (which is a pure test standard) does not give compliance to these process standards.
 
W

wrodnigg

#5
You can do it the short or the long way:

The long one: establish a usability engineering process

The short one: include usability in your risk management (add some questions to your risk analysis questionaire...)

(of course it is not that stupid-simple, but you should at least do something ;)
 
W

Watchwait

#6
Excellent point. I think by simply referencing the appropriate usability standard in the Essential Requirements portion of our Technical File, we will reduce our "audit risk" for this issue by 90+%, IMHO :agree1:
 

rmurp

Starting to get Involved
#7
Is there anyone out there making an ER for usability? That is the task at hand here and I am wondering if that is going to be a standard practice for medical device and drug companies.:confused:
 
F

freewind

#8
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!
 
S

SteveK

#9
Hi,

Just had our annual audit (ISO 9001, ISO 13485 and MDD 93/42/EEC). The Risk Management section of my Technical Files just invokes ISO 14971. I included a Usability section based on ISO 62366 in all my Technical Files prior to the audit (and in one TF submitted directly to the NB due to a ‘substantial’ change – which was accepted). The general comment from the auditor was along the lines “Good, you have included a Usability section in your TFs”.:2cents:

Steve
 
#10
However, my question is in regards to 62366 Usability Engineering for medical devices standard. We have a current ISO 13485 certification & ship product to the EU. Our product Technical File has been successfully reviewed by our Notified Body, and we do not reference EN 62366 in the Essential Requirements checklist. We do reference compliance to 60601-01 2nd Edition. Given this, where does conformance to the requirements in 62366 enter our picture, if at all?
It doesn't.

Just do the job and leave the evidence in your 'Usability Engineering File.'

(Our 'Usability Engineering File' is part of our Risk Management, and that is all held in the Technical File.)
 
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