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 4.8: Components of ME equipment

What does 4.8 require?

Every component, wiring included, whose failure might lead to a hazardous situation is operated inside its specified ratings, unless a specific exception comes from the standard or from risk management; components serving as means of protection have their reliability assessed against how they are used, and they meet the safety requirements of an applicable IEC or ISO component standard (without repeating tests already performed to it) or, where there is none, with this standard, other sources being usable to demonstrate compliance through the risk management process; compliance is confirmed by inspecting and, if needed, by testing, the standard's transformer and motor tests being comprehensive for those components.

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