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 4.9: Use of components with high - integrity characteristics in ME equipment

What does 4.9 require?

Where the failure of one particular component could create an unacceptable risk, that component must have high-integrity characteristics, and such components are chosen and assessed against how they will be used, and misused in reasonably foreseeable ways, over the expected service life; compliance is checked by inspecting the risk management file and the criteria used to choose them.

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