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,
Ray
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,
Ray