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 16.5: Separation devices

What does 16.5 require?

Where functionally connecting ME equipment to other items of the system or other systems could cause leakage current limits to be exceeded, safety measures incorporating a separation device are applied, having the dielectric strength, creepage and clearance of one means of operator protection for the highest voltage across it in a fault condition, the working voltage being that highest fault voltage but never less than the maximum mains voltage (earth potential differences between class I items without a common earth, and connections to nurse-call or data systems, are typical cases); checked by the tests of 8.8 and 8.9.

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