Usability/human factors engineering requirement (standard) for IVD medical device

pseudoazurin

Involved In Discussions
#1
Dear All,

Merry Christmas and Happy New Year,

Just want to check whether anyone has a summary or a list of requirements for usability/human factors engineering, including standards (e.g. CLSI or others) specifically for IVD medical devices. I know that there was "GP14-A Labeling of Home-Use In Vitro Testing Products; Approved Guideline, which described a lot about "pre-testing" like readability testing, focus interviews, ....etc, which are essentially usability testing alike, but the standard seems to be withdrawn.

Any idea or help?

Best regards!!
 
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yodon

Staff member
Super Moderator
#2
For devices, ANSI / AAMI / IEC 62366 is the usability engineering standard (harmonized in EU / consensus in US).
 

pseudoazurin

Involved In Discussions
#3
I know, but unfortunately, there is CLSI other IVD standards requirement that may need to be harmonized with 62366, at least need to be checked, and that is what I am trying to do. So I am looking for other IVD experts.
 
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