IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 4 to 5: general requirements and testing – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 4.1: Conditions for application to ME equipment or ME systems

What does 4.1 require?

Unless a clause says otherwise, the standard's requirements apply in normal use and in reasonably foreseeable misuse; and where the equipment or system compensates for or alleviates disease, injury or disability, every definition and requirement that speaks of the patient is read as applying to the person the equipment is intended for.

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