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 5.1: Type tests

What does 5.1 require?

The tests of the standard are type tests, chosen with clause 4 and especially the risk management of 4.2 in mind; a test may be skipped where analysis shows that other tests or methods have already evaluated the condition adequately; the risk analysis determines which combinations of simultaneous faults are tested, and the risk management file records any combination of independent faults, occurring together, that might lead to a hazardous situation, testing for basic safety and essential performance under them being limitable to worst cases.

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