IEC 60601-1 - Medical Electrical Equipment Safety
Clause 16: ME systems – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 16.6: Leakage currents

What does 16.6 require?

Within the patient environment, touch current from system parts, or between them, stays in normal condition at or below 100 microamps, and 500 microamps when any protective earth conductor that is not permanently installed is interrupted, leakage from accessible outer surfaces counting as touch current; the protective earth conductor current of a multiple socket-outlet feeding the system does not exceed 5 mA; the patient leakage and total patient leakage currents of the system in normal condition do not exceed the equipment values of Tables 3 and 4, the total measurable at installation; measured with the 8.7.4.4 device after the system reaches operating temperature (non-continuous systems cycled at rated periods to stability or for seven hours), at the highest rated mains voltage or on the local supply where characteristics can only be measured after installation, assembled per its documents, with the measuring circuit's reference earth on the supply earth where no isolating transformer is used and applied parts on an insulating surface 200 mm above earthed metal.

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