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What standards must the leakage current and insulation strength of the common mode inductance in medical monitors meet?

Time：2025-12-30 Views：75次

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Leakage current requirements:

BF type equipment: leakage current ≤10μA in normal state, and ≤50μA in single fault state; CF type equipment needs to pass a special test for cardiac current, with stricter leakage current limits.

Housing leakage current: all types of equipment must have a leakage current ≤500μA.

Insulation strength: insulation resistance: patient connection part ≥10MΩ (500VDC), non-patient part ≥5MΩ.

Withstand voltage test: apply 4kVrms/60s between input and output, leakage current ≤10mA, no breakdown or flashover.

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