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 16.4: Enclosures

What does 16.4 require?

Where non-ME equipment sits within the patient environment, any of its parts the operator can touch during routine maintenance or calibration after removing covers or connectors without a tool operate at no more than the 8.4.2 voltage limits and draw their supply from a source that two means of operator protection isolate from the mains; checked by inspection.

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

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