System Test
4 Testing and Maintenance
51
N O T E
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.
In case of an IT-power system, this safety test measurement requires a special measuring circuit, for
example with its own integrated TN-system or use of an external isolation transformer attached to the
safety test device.
Reference: Allowable Values for IEC 60601-1:1998 and UL 60601-1
Measurements
Protective Earth resistance (between the PROTECTIVE EARTH TERMINAL and any
ACCESSIBLE METAL PART which is PROTECTIVELY EARTHED, w/o power cord):
100mOhms
Protective Earth resistance of power cord: 100mOhms
Enclosure leakage current (IEC 60601-1 and UL60601-1): 100 µA (N.C.)
Enclosure leakage current:(IEC 60601-1): 500 µA (S.F.C)
Enclosure leakage current (UL 60601-1): 300 µA (S.F.C)
All values for current and voltage are the root mean square (r.m.s.) values, unless otherwise stated.
Insulation Resistance
It is not recommended to perform measurements of the insulation resistance. Refer to IEC 62353 for
details about methods of the insulation resistance measurement.
System Test
After mounting and setting up a system, perform system safety tests according to IEC/EN 60601-1-1.
Please refer to the patient monitor’s service guide for details on when and how to perform system tests.
What is a Medical Electrical System
A medical electrical system is a combination of at least one medical electrical piece of equipment and
other electrical equipment, interconnected by functional connection or use of a multiple portable
socket-outlet.
• Devices forming a medical electrical system must comply either with IEC/EN 60601-1-1 or IEC
60601-1 edition 3 clause 16.
• Any electrical device such as IT equipment that is connected to the medical electrical equipment
must comply either with IEC/EN 60601-1-1 or IEC 60601-1 edition 3 clause 16 and be tested
accordingly.
• Non-medical electrical equipment may require connection through a separating device (e.g. an
isolation transformer).
Test
Expected Test Results
Equipment Leakage Current Test (Single
Fault Condition - with mains cable)
X2 <= 300
A