Safety testing IEC 60601 series

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Hi everybody,

Tried to find some explanation on forum, but unsuccessfully.

Is here anyone who can advice me regarding safety and EMC testing?

Namely, my device is electro-mechanical robot, class II medical device. Device consisting of 5 main components. I conducted both EMC and safety testing acc to 60601-1-2 and 60601-1 a few years ago. Now, my development team changed one component and that component is EMC tested. Also, team added one new component (medical PC) also certified according to EMC.

Now question is, do I need to repeat 60601-1 and 60601-1-2 testing for whole system, although one component is significantly modified and one component is added?
Or because that components are already tested, I actually do not need to perform testing again?

Thanks in advance
 
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#3
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Carry out a risk analysis of the impact the changed components may have on Electrical safety such as leakage currents, MOOP, MOPP, etc., get in touch with your lab, and let them advise the rest. If you have already done this and both you and the lab concluded this is not necessary then the last step is getting the regulator to agree to that as well.
 
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