Wrist Actigraph Device - IEC 60601-1 general questions

L

luisf.rossi

#1
Hi,

We are certifying a wrist actigraph device and we have some doubts regarding IEC 60601-1 due to the simplicity of the device.

Should the electrical schematic be just a logical schematic or the real one with all electronic components soldered in the Main Board with PNs and values?

What is the detail level of the Critical Component List? Would be like: Battery, processor, accelerometer, memory? Or like electronic board?

How can I create an insulation Diagram? It is a battery powered device that is wrist worn ...

Thank you for the help.
 
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Mark Meer

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#2
Could you site the 60601-1 clauses in question? I did a quick search of the standard for "schematic", "critical component" and "insulation diagram", and got no results....

By "Electrical Schematic", I presume you mean what is referred to as "Circuit Diagram" in the standard? If so, then yes, this will have to be the detailed version (the "real one") in order to be assessed properly.
(NOTE: except for the clause on servicing, 7.9.3.3, there is no other requirement that I can see for providing a parts list with part-numbers).

By "Critical Components", do you mean "Components with High-Integrity Characteristics" (IEC60601-1, 3.17 & 4.9). If so, the definition is in 3.17.
This can be easily interpreted as "everything", because nearly everything has a purpose, but I don't think this is the intent. Because the standard specifically says "...in relation to the safety requirements....", I think the intent is to identify the components that have non-negligible risk associated, or are themselves risk-controls, as would have been identified in your risk analysis documentation.

I have no knowledge of insulation diagrams, but again, doing a quick search, I can't see anywhere in the IEC 60601-1 standard calling for these...
 
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