7 Testing and Maintenance
77
For any IT equipment (IEC 60950) operated in patient vicinity ensure that the equipment leakage
current does not exceed the limits described in IEC 60601-1. Use a separation device to ensure
compliance. After installation of IT equipment in patient vicinity, an enclosure leakage current test is
required.
If the combined devices forming the medical electrical system are connected to the same multiple
portable socket outlet, ensure that the resulting protective earth leakage current and equipment leakage
current do not exceed the limits of IEC 60601-1:2005+A1:2012/EN 60601-1:2006+AC:2010. The
medical electrical devices or IT equipment may be located in or outside the patient vicinity in a
medically used room. Avoid using multiple portable socket outlets. If the limits of IEC 60601-
1:2005+A1:2012/EN 60601-1:2006+AC:20101 are exceeded, additional protective measures are
required, e.g. a separation device or the connection of each device to separate mains.
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