Usability of ME Equipment - IEC-62366-1:2015

[KOrellana]

Hello everyone,

Currently, I'm putting together the usability of ME equipment for a submission for one of our products. This is the first time ever that I'm dealing with the usability of ME equipment submission. Reading through IEC-62366-1:2015, I'm confused about what actually goes in the usability of ME equipment documentation.

I understand that a scope must be submitted, but what other documentation(s) is needed for the submission?

If it's not any trouble, can anyone give me a quick breakdown what needs to be included in the usability of ME equipment documentation and a brief description of each section?

It would be greatly appreciated if anyone were able to help me out in this dilemma. Thank you for your time.

 

[SteveK]

Bit out of date but this may help:

https://elsmar.com/elsmarqualityfor...-62366-2008-medical-devices-3.html#post400541

Steve

 

[KOrellana]

Thank you. I did discover information that had painted a better picture for me.

Now my following up question would be, under section 4 in IEC 62366-1:2015, it lists the following sections:

Usability engineering process
Risk control as it relates to user interface design
Information for safety as it relates to usability
Usability engineering file
Tailoring of the usability engineering effort

Does all of these sections have to be included into the Usability of ME equipment with the scope?

 

[Marcelo]

The easiest way to understand regulatory expectations for human factors is what is in annex A of this document - https://www.fda.gov/downloads/MedicalDevices/.../UCM259760.pdf .. Please note that it does now follow exactly the IEC 62366-1 requirements.