IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 4 to 5: general requirements and testing – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 4.6: ME equipment or ME system parts that contact the patient

What does 4.6 require?

The risk management process considers whether parts that can touch the patient, though not applied parts by definition, should meet the applied-part requirements; if it decides so, the type B applied-part requirements apply unless the assessment shows type BF or CF is needed, and every relevant requirement and test of this standard, and of its particular and collateral standards, then applies to those parts except the applied-part marking of 7.2.10; compliance is checked by inspecting the risk management file.

Maintained by Gerard BlokdykControl text last updated

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