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Looking for Usability File Template acc. IEC 62366-1 and IEC 60601-1-6

pashah

Registered
#1
Hi all,

Until now we have just used the clauses from the standard EN 62366 and it was easier to create the document template for Usability engineering file. But now we are implementing the IEC 62366-1 and we find it difficult and we are confused at the moment on how to go forward.

If you could help out with a template for usability engineering file covering aspects of IEC 62366-1 and IEC 60601-1-6, it would be very useful.

Thanks in advance.
 

pashah

Registered
#3
Do you have a copy of the standard? It lays out pretty clearly what the documentation requirements are.
Yes, obviously I do! But it is not at all clear for us how it was with the EN 62366; which is why I am looking for solutions that would help us move towards the next step. Thanks for your response though.
 

yodon

Staff member
Super Moderator
#4
No offense intended, it's not infrequent that posters don't have a standard and ask for info they can get if they had a copy.

Like other 'files' the UE file is typically a virtual file - a compilation of individual files; e.g. a separate UE spec, separate UE Plan, etc.

Do note there's a significant overlap with other aspects like risk management and software (if in your device). So one document may fulfill aspects of several standards; e.g., a use fmea, if used, would be included (referenced) in both the risk file and the UE file.

Some people maintain an index pointing to where the specific elements are covered. This isn't required but may be helpful in organizing and managing.
 

pashah

Registered
#5
No offense intended, it's not infrequent that posters don't have a standard and ask for info they can get if they had a copy.

Like other 'files' the UE file is typically a virtual file - a compilation of individual files; e.g. a separate UE spec, separate UE Plan, etc.

Do note there's a significant overlap with other aspects like risk management and software (if in your device). So one document may fulfill aspects of several standards; e.g., a use fmea, if used, would be included (referenced) in both the risk file and the UE file.

Some people maintain an index pointing to where the specific elements are covered. This isn't required but may be helpful in organizing and managing.
None taken! I understand the concept of a UE file. It is such that I have worked in different companies. One of them had a similar documentation procedure as you mentioned with USP, UVP, UVR and UEF. But now I am working for a smaller company and they always had just one UEF. So, I am trying to figure out at the moment how can we implement this new IEC 62366-1 at this specific company without a lot of fuss. As we also need to cover the usability aspects mentioned in the IEC 60601-1-6.
 
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