IEC 60601-1 - Medical Electrical Equipment Safety
Clause 16: ME systems – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 16.9: ME system connections and wiring

What does 16.9 require?

Connection terminals and connectors prevent incorrect tool-free connection where a hazardous situation could result: connectors meet 15.4.1, patient lead and cable plugs cannot fit other outlets of the system likely to be in the patient environment unless shown harmless, and medical gas connections for different gases are not interchangeable. A multiple socket-outlet allows connection only with a tool, or cannot accept the mains plugs of IEC/TR 60083, or is supplied through a separating transformer; it carries the general warning sign visible in normal use and either which equipment may be attached or its maximum continuous output (amperes or volt-amperes); it complies with IEC 60884-1 with 8.9 distances, class I construction with the earth conductor to the socket earthing contacts, 8.6 earth terminals and connections with the system's total earth path allowed up to 400 milliohms or more under 8.6.4, 8.4.2 enclosures, 8.11.4 terminal devices, component ratings per 4.8, keyed tool-free connectors and an 8.11.3 power cord; with a separating transformer, the transformer complies with this standard or with IEC 61558-2-1 without its 1 kVA and IPX4 limits, the assembly is class I with its ingress protection specified and marked, and the outlet is permanently connected to the transformer or of a type that cannot accept ordinary mains plugs. For each part sharing a mains connection the total protective earth path tested as a unit meets 8.6.4, the impedance from the mains plug earth pin to any earthed part not exceeding 200 milliohms; earth connections are made so removing any single item does not interrupt the earthing of another without also disconnecting its supply; additional earth conductors detach only with a tool; and conductors between items are protected against mechanical damage.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clause 16: ME systems – IEC 60601-1 - Medical Electrical Equipment Safety

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