L
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.
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.