Futureproofing: Dormant Components in a Medical Device

M

mr.mike

#1
In prototyping our device, we are wanting to "future-proof" it by adding a wireless component, even though, for this initial version, the device will be interfaced with manually (though a panel on the device itself).

So my question is, does this pose any potential issues in terms of IEC 60601-1-2 testing?

In otherwords, if an embedded component is presently not doing anything, but has the potential to in the future (through a future firmware upgrade), is it necessary to have it's function tested? Or can it be ignored until such time that the necessary firmware to control it is released?

As always, any input is greatly appreciated.
Thanks in advance,
MM.
 
Elsmar Forum Sponsor
#2
My thoughts would be that you would not have to include it at first - but when you added the wireless feature it would have to be tested.

Doing the testing in two parts would probably be more expensive than just doing it all together, but might allow you to get your product out before the wireless features were developed.
 

Peter Selvey

Staff member
Super Moderator
#3
Yes, it's clear that this is a cost issue, not a regulatory issue. Standards use the term "normal use" for testing. If the component is dormant in "normal use" then this is the condition it should be tested in.

For cost, you may wish to activate the component anyway. But I could imaging for EMC testing there may be special considerations for wireless so may be easier to leave until later.

For other tests (e.g. electrical safety), you might want to turn it on, to avoid for example repeated tests for power input, temperature etc.. I expect the additional load to the power supply is small enough that no failure is expected, but large enough to warrant some repeat testing. In that case it is cost effective to turn it on to avoid repeat testing later.
 
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