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IEC 60601-1 testing for device with its own 2V battery power supply necessary?

M

messer

#1
Hello, i will prepare a 510k registration, but i'm not sure which tests are necessary to demonstrate the electric safety. The standard 60601-1 describes the electric safety for medcial devices.
The device is has only a small battery with less than 2 V and no external power. Can I easily explain that the device is safe, because no risk health exists? Or is there a specific standard for devices with low power/voltage?
Many thanks for all answers in advance!
 
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S

SteveK

#2
I think you will find that IEC 60601-1 still applies to low voltage battery driven medical devices. It is just that a large majority of the clauses will be "not applicable" or be easy to state compliance. There is nothing to stop you doing what tests are required e.g. a rub test on markings (clause 7.1.3). Just because it is a low voltage battery device does not mean there are no risks (under ISO 14971) - consider the issues with lithium battery cells that have cropped up.:2cents:

Steve
 
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