Mindray DP-20 - Earth Leakage Test; Patient Leakage Current

Electrical Safety Inspection B-3
B.5 Earth Leakage Test
Run an Earth Leakage test on the device being tested before performing any other leakage
tests.
The following outlet conditions apply when performing the Earth Leakage test.
⚫ normal polarity (Normal Condition);
⚫ reverse polarity (Normal Condition);
⚫ normal polarity with open neutral (Single Fault Condition);
⚫ reverse polarity with open neutral (Single Fault Condition).
◼ LIMITS
For UL60601-1,
⚫ 300 μA in Normal Condition.
⚫ 1000 μA in Single Fault Condition.
For IEC60601-1,
⚫ 500 μA in Normal Condition.
⚫ 1000 μA in Single Fault Condition.
B.6 Enclosure Leakage Test
The following outlet conditions apply when performing the Enclosure Leakage test.
⚫ normal polarity (Normal Condition);
⚫ reverse polarity (Normal Condition);
⚫ normal polarity with open neutral (Single Fault Condition);
⚫ reverse polarity with open neutral (Single Fault Condition);
⚫ normal polarity with open earth (Single Fault Condition);
⚫ reverse polarity with open earth (Single Fault Condition).
◼ LIMITS
For UL60601-1,
⚫ 100μA in Normal Condition.
⚫ 300 μA in Single Fault Condition.
For IEC60601-1:
⚫ 100μA in Normal Condition.
⚫ 500 μA in Single Fault Condition.
B.7 Patient Leakage Current
Patient leakage currents are measured between a selected applied part and mains earth. All
measurements have a true RMS only.
The following outlet conditions apply when performing the Patient Leakage Current test.
⚫ normal polarity (Normal Condition);
⚫ reverse polarity (Normal Condition);
⚫ normal polarity with open neutral (Single Fault Condition);
⚫ reverse polarity with open neutral (Single Fault Condition);
⚫ normal polarity with open earth (Single Fault Condition);
⚫ reverse polarity with open earth (Single Fault Condition).