As Geoff says you can't just look at it from an electrical point of view as 60601 requires you to look at all aspects of the design including mechanical, functional and even the colour of indicators. You would need to submit your completed design for examination including a full written risk assessment in order to be able to prove you comply with 60601 before the device can be brought to market or used within a patient environment.

Many think that just sticking an isolation transformer on any device makes it comply with 60601 but this is not the case and has never been.

As always the problems will begin if there is ever an incident involving a device and then you better be sure you can prove your work is bullet proof! (Just sticking an isolation transformer on something will not be good enough!)