Global medical device human factors/usability requirement

pseudoazurin

Involved In Discussions
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:

Marcelo

Inactive Registered Visitor
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
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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