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 4.10: Power supply

What does 4.10 require?

Equipment is suited to the supply mains, or specified for use with a separate power supply, or runs on an internal electrical power source, or some mix of these, as the accompanying documents state; for mains-connected equipment the rated voltage does not exceed 250 V for hand-held equipment, for equipment and systems rated at no more than 4 kVA, 250 V where the supply is d.c. or single-phase and 500 V where it is polyphase, and 500 V otherwise; and the supply mains is assumed to have overvoltage category II unless the manufacturer specifies higher, voltage within 90 to 110 percent of nominal, a practically sinusoidal and symmetrical supply, frequency up to 1 kHz within stated deviations, the protective measures of IEC 60364-4-41, and d.c. ripple not above 10 percent of the average, beyond which the peak voltage applies.

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