7 Testing and Maintenance
72
inspection, testing or analysis, as specified in the IEC 60601-1:2005+A1:2012/EN 60601-
1:2006+AC:2010 or in this book.
Medical electrical equipment must comply with the requirements of the general standard IEC/
EN 60601-1, its relevant particular standards and specific national deviations. Non-medical electrical
equipment shall comply with IEC and ISO safety standards that are relevant to that equipment.
Relevant standards for some non-medical electrical equipment may have limits for equipment leakage
currents higher than required by the standard IEC 60601-1:2005+A1:2012/EN 60601-
1:2006+AC:2010. These higher limits are acceptable only outside the patient environment. It is
essential to reduce equipment leakage currents when non-medical electrical equipment is to be used
within the patient environment.
System Example
This illustration shows a system where both the medical electrical equipment and the non-medical
electrical equipment are situated at the patient’s bedside.
WARNING
• Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple
portable socket-outlet is used, the resulting system must be compliant with IEC 60601-
1:2005+A1:2012/EN 60601-1:2006+AC:2010. Do not place multiple socket-outlets on the floor.
Do not exceed the maximum permitted load for multiple socket-outlets used with the system. Do
not plug additional multiple socket-outlets or extension cords into multiple socket-outlets or
extension cords used within the medical system
• Do not connect any devices that are not supported as part of a system.
• Do not use a device in the patient vicinity if it does not comply with IEC/EN 60601-1. The whole
installation, including devices outside of the patient vicinity, must comply with IEC 60601-
1:2005+A1:2012 / EN 60601-1:2006+AC:2010. Any non-medical device, including a PC
running an OB TraceVue/IntelliSpace Perinatal system, placed and operated in the patient’s
vicinity must be powered via a separating transformer (compliant with IEC 60601-
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