Isolation/Insulation Diagrams - IEC 60601-1

#1
Hi everyone.
My company is developing a medical device and we are looking to comply to IEC 60601-1. We've seen a lot of mention of an "isolation diagram" or insulation diagram being required as a first step but we can not find a reference to it in the standard, could anyone give me the clause which requires or can be interpreted to require a isolation diagram?

Thanks in advance!
 
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#2
Hi everyone.
My company is developing a medical device and we are looking to comply to IEC 60601-1. We've seen a lot of mention of an "isolation diagram" or insulation diagram being required as a first step but we can not find a reference to it in the standard, could anyone give me the clause which requires or can be interpreted to require a isolation diagram?

Thanks in advance!
You're right, 60601 does not require an insulation diagram explicitely. But since a lot of test reports use the TRF (test report form) from IECEE this a a common thing to start with.

There are a lot of clauses relating to the electrical safety, most obvious section 8, and there in section 8.5 you shall implement means of protection (MOP) against electrical shock. See also cl. 3.43 for the definition of "insulation co-ordination".

The insulation diagram is is very helpful tool for the manufacturer and the tester, to identifiy, where such MOP are implemented in the device and which requirements apply to each single MOP.

So don't just look for an explicite reference in the standard, but also look for your benefit during development and testing of your device. Wiothout an proper insulation concept and diagram, it is hard for you to fulfill all requirements.
 
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