Medical Device which is NOT a PEMS?



Sorry for asking for very basic question.
Can someone guide me on understanding PEMS (IEC60601-1 Clause 14).

For starter I want to understand what is NOT A PEMS. (Programmable Electrical Medical System)


It is quite possible that this question is already asked; will be happy to read through existing answers.

I have spend some time with Google and standards; but mostly data is confusing me on PEMS and Software, which forced to me write here.


Super Moderator
Per the definition, it is Medical Electrical (ME) equipment or an ME system containing one or more programmable electronic subsystems (PESS). So anything that contains software (and the definition HAS expanded to firmware and arguably down to FPGA level code) is considered PEMS.

Are you able to post anything about whatever is confusing?
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