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 5.7: Humidity preconditioning treatment

What does 5.7 require?

Ahead of the 8.7.4 leakage current testing and the 8.8.3 dielectric strength testing, all equipment or its parts influenced by the simulated climate undergo humidity preconditioning: set up complete or partially with transport covers detached, tool-free detachable parts detached but treated with the main part and tool-free access covers opened, in a cabinet at 93 percent relative humidity within 3 percent at the sample and a temperature within 2 K of a value T between 20 and 30 degrees, after being brought to between T and T plus 4 degrees for at least four hours; 48 hours for enclosures rated IPX0 and 168 hours for enclosures with higher ingress protection, extended where the risk management process indicates prolonged exposure to high humidity such as outdoor use; then reassembled.

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