@ScottSeidman , do you know if the 60601 particular standard for ECG require a self-test circuit? I've read the -2-27 yesterday, but didn't see anything about self-test. I'm in the process of reading the -2-25.
One thing to be very careful of is the firmware, though. I can't imagine a special ECG requirement for self-test -- as a plain old vanilla analog ecg wouldn't have one. You need to meed all the hardware and firmware guidances.
IEC 62304 might be the relevant document -- sunstonepilot.com/2018/09/… -- I would think self-testing comes into the risk-management process.
oops, I mean software and firmware. Interestingly, I know people who recommend skewing toward FPGA's over microcontrollers, because the standard is black box testing instead of white box.