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AFE44xx pulse oximeter frontend & medical certification

hello,

i am currently working on a project utilizing the AFE44xx pulse oximeter front end and i am wondering what is the minimum external circuitry needed to pass medical certifications (besides capacitors/oscillator mentioned in the app-note of course).

I am especially interested in over-current protection through the LED in case the AFE44xx device fails (single fault condition). Do I have to implement active current monitoring on the TX Led supply rail or is that not necessary using this device?

Thanks very much in advance.

Regards, jo