IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 11 to 13: temperatures, fire, outputs, hazardous situations and fault conditions – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 12.2: Usability of ME equipment

What does 12.2 require?

The manufacturer deals with risks from poor usability, including risks tied to identification, marking and documents, by running a usability engineering process that meets IEC 60601-1-6, checked as that collateral standard specifies.

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