Operation Manual

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”)