B-4 Electrical Safety Inspection
B.8 Mains on Applied Part Leakage
The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage,
through a limiting resistance, to selected applied part terminals. Current measurements are
then taken between the selected applied part and earth. Measurements are taken with the
test voltage (110% of mains) to applied parts in the normal and reverse polarity conditions
The following outlet conditions apply when performing the Mains on Applied Part test.
Normal Polarity;
Reversed Polarity
LIMITS
For BF
applied parts: 5000 μA
B.9 Patient Auxiliary Current
Patient Auxiliary currents are measured between any selected Applied Part connector and the
remaining Applied Part connectors. All measurements may have a true RMS only response.
The following outlet conditions apply when performing the Patient Auxiliary 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).
LIMITS
For BF
applied parts,
100μA in Normal Condition
500μA in Single Fault Condition
NOTE: Make sure the safety analyzer is authorized comply with requirement of IEC60601-1.
Follow the instructions of the analyzer manufacturer.
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