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System Test Procedure
If the medical electrical device has already been tested as a standalone device e.g. during factory safety
testing, an equipment leakage current test must only be performed once the device is connected to
another electrical device/system. If the medical electrical system has not been tested as a standalone
device, the device has to be tested as a standalone device (without connection to the system) and as
part of the system (with connection to the system).
Connect the detachable power cord of the device under test to the safety analyzer's test mains port.
Connect the enclosure test lead of the safety analyzer to the enclosure of the device under test, as
described in the section dealing with the equipment leakage current test. Refer to the documentation
that accompanies the safety analyzer for further details on how to set up the test.
Test
Equipment Leakage Current test (normal
condition)
Equipment Leakage Current test (Single Fault
condition)
After the testing of the device as a standalone device and as part of the system, check that the resulting
values (without connection and with connection to the system) do not differ by more than +/- 10%
from each other.
7 Testing and Maintenance
Expected Test Results
Sys1 <= 100 μA
Sys2 <= 300 μA
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