[stubish]

Keyword 'may'.

A learning thermostat would apply, say one that uses historical records to predict changes in temperature and preemptively adjusts. And it would be low risk and unregulated in most cases. But attach to a self-heating crib or premature baby incubator and that would jump to high risk and you might have to prove it is safe.

[butlike]

So if the thermostat jumps to 105 during the night, that's not considered 'high-risk?'

[stubish]

Maybe you are right and it is still risky for sleeping adults. In any case, even high risk the standard that needs to be followed might be as simple as 'must have a physical cutoff at 30C'.