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138 GMC-I Messtechnik GmbH
Appendix
10.3 Testing Devices in Accordance withIEC 62353 / DIN EN 62353 (VDE
0751-1)
Visual inspection is performed before metrological testing is
executed. Testing must be conducted in order to determine
whether or not:
Externally accessible fuses comply with the values specified by
the manufacturer
(nominal current value, blowing characteristics)
Labeling required on the device/system is legible and complete
The mechanical condition of the device allows for continued
safe use
Safety impairing damage or contamination can be detected
The accessories and/or disposables used with the device/
system will also be evaluated (e.g. mains cable, patient cables,
tubing)
The required documentation is available and complete
The following measurements can be performed in accordance
with the above mentioned standard:
Protective conductor measurement R PE, test current:
200 mA DC
Insulation measurement (optional)
R ISO (insulation resistance LN to protective conductor)
Equipment leakage current with the following measuring meth-
ods:
– Direct measuring method
– Alternative measurement (Equivalent device leakage current)
– Differential current measuring method
Patient leakage current or equivalent patient leakage current
(patient leakage current is not possible in the event of the SFC:
“mains at application part”)
138


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