Testing should be as strict as is needed. I'm arguing/assuming that US testing standards for medical devices is overly strict.
I think* there is the same "maximum" standard for all medical devices. But what's appropriate for a pacemaker is overkill for a CPAP machine.
* but am happy to be corrected (Cunningham's Law)
There are multiple classifications for medical devices.
CPAPs are class 2 devices whereas a pacemaker is class 3. I don’t want to over simplify, so I will link you to the FDAs entry point into the Byzantine maze of classifications.
https://www.fda.gov/medical-devices/overview-device-regulati...
Testing should be as strict as is needed. I'm arguing/assuming that US testing standards for medical devices is overly strict.
I think* there is the same "maximum" standard for all medical devices. But what's appropriate for a pacemaker is overkill for a CPAP machine.
* but am happy to be corrected (Cunningham's Law)