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7 Testing and Maintenance
Case 2: Medical Device Combined with a Non-Medical Device
If you combine a medical device with a non-medical device to form a medical electrical system
according to IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010, additional protective
measures are required, e.g. usage of a separation device. The medical electrical devices or the IT
equipment may be located in or outside the patient vicinity in a medically used room. After system
installation incl. protective measures, a system test is required to ensure that the resulting equipment
leakage current and applied part leakage current does not exceed the limits of IEC 60601-
1:2005+A1:2012/EN 60601-1:2006+AC:2010.
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Troubleshooting
