Usability Engineering ISO 62366:2008 - Medical Devices

D

DangerousDave

#11
I may be mistaken (famous last words) but I think 3rd edition of 60601-1-6 has been slimmed down a lot and really just referes you to 14971 and 62366 . . . .

Could someone confirm this?
 
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K

katuser

#12
is there a way to download a full template of an usability engineering file? I would be already happy with ehadlines and a description what should go into the chapter. I am new to this and have absolutely no idea how to start. thanks!
 
D

DangerousDave

#13
is there a way to download a full template of an usability engineering file? I would be already happy with ehadlines and a description what should go into the chapter. I am new to this and have absolutely no idea how to start. thanks!
The usability standards I have seen are process based standards. Certainly within my company, there is no usability engineering file, but usability forms part of the product development process and procedures. Our evidence of this is in the procedure, project file and risk management where usability related items are mentioned.
 
S

SteveK

#14
is there a way to download a full template of an usability engineering file? I would be already happy with ehadlines and a description what should go into the chapter. I am new to this and have absolutely no idea how to start. thanks!
I have attached an example of one of my usability files; in this case for a Bubble Humidifier, if this is of any help.

Steve
 

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sagai

Quite Involved in Discussions
#15
Niiiice work ! :)
I am only wondering, may be I have overlook, how the worst case scenarious covered.
Thanks
Sz.
 
S

SteveK

#16
Hi Sz,

In the worst case scenario section (2.2) it is a judgement call, however there may be literature to back this up that you can use as a reference in the Usability File. I regularly scan medical device alerts (MHRA [UK], FDA [USA - MAUDE], Afssps [France], Salute [Italy], MDCO [Hong Kong] etc). These can illustrate a worst case e.g. an event leading to death or serious injury. An example from MAUDE database (FDA - ID 1712843) indicated that a portable suction device did not operate, so a patient’s airway could not be cleared leading to death. The reason for lack of function being that the (battery) device was not kept on charge.

Steve
 
J

JulieM

#17
Thanks Steve, The information is extremely helpful as we are having to do usability engineering testing and reporting on our devices.
 
L

Laura P

#18
I’m an R&D member and my group and me are working on a new prototipe of device for dialytic treatment.
In this moment my task is to verify how to integrate the Usability process in our requirement management system and to complete it with the Risk Analysis procedure.
My question is the following: 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?
What’s the difference between the 60601-1-6 (2th edition) and ISO 62.366?
Please, give me an helping hand! Thanks!
 
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sagai

Quite Involved in Discussions
#19
62366
"
4.2 * USABILITY ENGINEERING FILE
The results of the USABILITY ENGINEERING PROCESS shall be recorded in the
USABILITY ENGINEERING FILE. The RECORDS and other documents that form the
USABILITY ENGINEERING FILE may form part of other documents and files.
EXAMPLE 1 MANUFACTURER’S product design file
EXAMPLE 2 RISK MANAGEMENT FILE
"
br
Sz.
 

Marcelo

Inactive Registered Visitor
#20
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?
 
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