USB power between Medical Device Data Collection Device Component


Here is the current (no pun intended) state;

We make a medical device that has two components, a medical grade tablet computer and a proprietary data collection device which has been tested and meets 60601-1 requirements. Each is powered by its own medical grade external power supply.

The future state still has both of the components, The tablet computer is still powered by it external power supply, but the data collection device is powered via USB from the tablet computer.

My question is if I need to repeat the electrical safety testing on the data collection device since I have changed the way it is powered?

Thanks for your help,



It depends on the way your insulation design is done. And the way your have promote your device to the test lab.
If the external power supply is part of your certification (as critical component) when removing it cancels the certificate.
If your device was tested as powered by USB port (with a statement that USB power provider is IEC60601 o r IEC60950 ) then you are quite safe.

Usually when using and external power, most of the safety (MOOP, MOPP) are inside the power.
So if it is powered by tablet, the tablet should insure the same safety level.
Take care also that if you tablet wasn't certified to provide power to other device, NB could ask to update your safety test for the tablet


If previously it was powered via external power supply and now being powered by Tablet (assuming the rating of the data collection device has not changed) and is same as when it was connected to external power supply ) which is already approved to 60601, then some points to keep in mind are:

a) you might not have to repeat all the tests, maybe a partial evaluation with USB connector (SIP/SOP).

b) if the data collection device can be used while it is being connected to Tablet (charging mode), then it would be better to specify in manual that it has to be connected to your tablet (model and mfr must be specified). If there are no restrictions placed in the manual then it depends on the test lab how they will assess this situation.
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