Global medical device human factors/usability requirement

pseudoazurin

Involved In Discussions
#1
Dear All,

Just want to check with your experience regarding medical device usability. Besides US and EU, is there any country that specifically requires usability/human factors/IEC 62366, besides the result of ISO 13485:2016 or IEC 60601-1 (ed 3 or 3.1+) or (ISO 14971:2018+)

Many thanks.
 
Last edited:
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Marcelo

Inactive Registered Visitor
#2
Several regulations (most of them, I would say) have general human factors/usability requirements, explicitly or implicitly.

Most countries do not explicitly require human factors/usability documentation on a submission, however.

Brasil, for example, has explicit requirements for equipment under INMETRO certification, and for some IVDs.
 

Marcelo

Inactive Registered Visitor
#4
The only explicit ones for IVDs is for Glucose meters, ANVISA requires that they perform usability testing.

For medical electrical equipment, IEC 60601-1-6 is mandatory, which means IEC 62366 is also mandatory.
 
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