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 4.4: Expected service life

What does 4.4 require?

The risk management file records the expected service life the manufacturer assigns to the equipment or system, since single fault safety, component evaluation and the detectability of faults are judged across it; compliance is checked by inspecting the file.

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