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Patient Safety Tests
4-44 Testing the Monitor
Patient
Leakage
Current, with
Mains Voltage
on the Applied
Part
This test measures patient leakage current in accordance with EN60601-1, Clause 19, for
Class I, type CF equipment. In this test, 110% of mains voltage is applied between each
patient connection and earth (power ground). Patient leakage current is then measured from
any individual patient connection to earth.
WarningWarning
AC mains voltage is present on the applied part terminals during this test. Exercise
caution to avoid electrical shock hazard.
Table 4-7. Safety Tests - Patient Leakage Current, with Mains Voltage on the
Applied Part
What to record on the service record:
S(5): P or S(5): F
Test or “Inspection” to Perform Expected Test Results
Patient Leakage Current - AC
See “Safety Test Diagram - Patient
Leakage Current - AC” on page 4-44
Maximum leakage current = x
<= 50 µA @ 250V (IEC601-1 or UL2601-1)
Test at 110% of the nominal line voltage.
Figure 4-2 Safety Test Diagram - Patient Leakage Current - AC
Test or Inspection to Perform
Measures patient leakage current from Applied Part to earth caused by external mains
voltage on Applied Part with switch S5 open and closed. Each polarity combination
possible is tested using S2 and S6.
Safety test according to EN60601-1 (Clause 19.4.h). Report largest value.