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Safety Testing
104 Chapter 9 Preventive Maintenance, Care and Cleaning
Safety Tests
S(2): Protective
Earth Test
Test to perform:
The protective earth test measures impedance of Protective Earth (PE) terminal to all
exposed metal parts of the Instrument under Test (IUT) which are connected to the
Protective Earth (PE) for safety reasons. Normally it includes the wiring in the mains cable
(max. 200 mOhm).
A test current of 25 Amps is applied for 5 to 10 seconds. It is recommended to flex the main
cable during the test to identify potential bad contact or damage to the earth wire.
Safety test according to IEC 60601-1 (Clause 18).
Report the highest value.
S(3): Patient
Leakage Current
Test - AC
Test to perform:
The patient leakage current test measures patient leakage current from the applied part to
the earth caused by external main voltage on the applied part. Each polarity combination
possible is to be tested. This test is applicable for ECG and SpO
2
.
Safety Test according IEC 60601-1 (Clause 19.4h).
Report the highest value.
S(4): Enclosure
Leakage Current
Test
- Normal Condition
(NC)
Test to perform:
The enclosure leakage current: normal condition test is applicable to Class 1 and 2
equipment, type B, BF, and CF Applied Parts. The test measures leakage current of exposed
metal parts of the Instrument Under Test; it also tests normal and reversed polarity.
For Type BF and CF Applied Parts the test measures AP/GND.
Safety Test according to IEC 60601-1 (Clause 19.4g).
Report the highest value.
S(5): Enclosure
Leakage Current
Test
- Single Fault
Condition (SFC)
Open Supply
Test to perform:
The enclosure leakage current: single fault condition open supply is applicable to Class 1
and 2 equipment, type B, BF, and CF Applied Parts. The test measures leakage current of
exposed metal parts of the Instrument Under Test with one supply lead interrupted; it also
tests normal and reversed polarity.
For type BF and CF Applied Parts the test measures AP/GND.
Safety Test according IEC 60601-1 (Clause 19.4g).
Report the highest value.
S(6): Enclosure
Leakage Current
- Single Fault
Condition Open
Earth (Ground)
Test to perform:
The enclosure leakage current: single fault condition open earth (ground) test is applicable
to Class 1 equipment, type B, BF and CF Applied Parts. The test measures leakage current
of exposed metal parts of the Instrument Under Test with Protective Earth open-circuit and
normal; it also tests reversed polarity. For type BF and CF Applied Parts the test measures
AP/GND.
Safety Test according IEC 60601-1 (Clause 19.4g).
Report the highest value.