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Copyright © Lojer Oy, 2013
02/2013 Rev. 1.0
Tests performed by non-qualified personnel might cause injury or damage to the device which the manufacturer
is not responsible for.
PROTECTIVE
EARTH
RESISTANCE
Test is performed only for Class I equipment. All accessible conductive parts should be
included into test. Measurement current should be 200 mA. The total resistance should not
exceed
0,3 Ω
.
Detachable power cords kept ready for use should be measures as well. Their resistance
should not exceed
0,1 Ω.
Before testing check the earth conductors and change them if necessary. Test is performed
between the protective earth connector of the mains plug and protectively earthed accessible
conductive part. The measured resistance should not exceed 0,2
Ω
. Test both the potential
equalization point and the frame.
If the device is disassembled or the protective earth conductors have been changed,
protective earth resistance should be measured from various points.
LEAKAGE
CURRENTS
The measuring device should be appropriate for testing leakage currents.
Detach the power cord of the medical device and connect it to the measuring device. Attach
the protective earth measurement lead to the point under test (change points if necessary).
Attach the applied parts to the measuring device. (Note! In Class I equipment a leakage
current measurement can be performed only after the protective earth testing has been
passed.)
Use the correct measurement method and procedures related to that.
Currents to be measured:
Equipment leakage current (current from the mains part to earth through protective
conductor and accessible parts and applied parts): Class I, type B applied part 500µA.
Applied part leakage current (current from the mains part and the accessible parts to applied
parts of the device): Class I, type B applied part 5000µA.
EVALUATION: The evaluation of safety of the tested equipment should be performed by electrically skilled person,
who has the appropriate training for the equipment under test.
FUNCTIONAL
TEST
Perform the procedures mentioned in Section 5.1. Go through all functions in order to make
sure that the device is working correctly. Stop using the device if you notice any defects e.g.
the device is making noise or functioning in sufficiently. Contact the service.
REPORTING OF
RESULSTS
All test performed should be documented. The documentation should include at minimum the
identification of the testing organization, name of the person who performed the tests,
identification of the equipment, details of the tests, date and the result of the functional tests
and measurements.