54
15.7
PLeak
– Patient leakage current
Explanation
VDE 0701-0702
VDE 0751-1 /
EN 62353
VDE 0544-4 /
EN 60974-4
Class
Class
Class
Class
Class
Class
Class
I
II
III
I
II
I
II
-
-
-
X
X
-
-
The patient leakage current is the current that flows from active
applied parts via the patient to earth or to the PE conductor.
It is tested at mains voltage for medical devices of protection
classes I and II to prove proper insulation capacity. This is to
ensure that no leakage current flows from the active applied parts
to earth and that there is no risk of a dangerous electric flow for
the patient.
For this purpose, the following measuring methods may be used:
direct current measuring method
alternative leakage current measuring method
For the direct current measuring method, the test
socket is supplied with mains voltage.
The patient leakage current is measured exclusively on
the test sample and its applied parts.
No measurements may be carried out on the patient!
The alternative leakage current measuring method is
only admissible if the test is carried out at mains
voltage.
The IPLeak test must only be carried out after the RPE
and RInsu tests have been passed.
For the direct current measurement, the patient leakage
current must be measured with both polarities.
L<->N, N<->L
If the measured value of the alternative leakage current
measurement exceeds 1 mA, the direct current
measurement must be carried out.
For the alternative leakage current measurement, L and
N conductors are shorted. The leakage current can be
twice the value for test samples with bipolar circuit
breakers.
For such test samples, the device leakage current may
be halved.
Check whether the measuring circuit is closed before
starting the test. Otherwise, no patient leakage current
is measured and the test result will be incorrectly
displayed as being positive.
Separate measurements of the patient leakage current
of applied parts of type B must only be carried out if
prescribed by the manufacturer (see accompanying
documents).
When testing medical electrical devices (ME devices)
with several applied parts, these must be connected
one after the other.
Application
Class I, IPLeak, direct current measuring method
The polarity of L-N must be reversed.
Connection diagram
VDE 0751-1 (applied parts of type F)
Circuit diagram
VDE 0751-1 (applied parts of type F)
Place the test sample onto an insulated surface.
Insert the shock-proof plug of the test sample into the test socket
of the appliance tester.
The test sample is supplied with mains voltage and must be
tested in all switch positions (device functions).
Use the test probes to scan all accessible conductive parts and
applied parts.
