[nomel]

What standard exactly, for a stethoscope?

I know nothing of this, but it looks like stethoscopes are Class 1 medical devices with 501(k) exemption, and fall under the "Good manufacturing practices" guidelines of Quality System Regulation (21 CFR 820), but that seems pretty squishy.

[conception]

CFR 21 being labeled squishy is a first for me.

[nomel]

CFR 21 is the whole thing. I'm specifically referring to Part 820, within the context of a stethoscope.

[conception]

Fair