I'm looking at a medical device (on market in EU and USA), that is chargeable via USB.
Included in the system-kit is simply the device and a USB cable. The charging instructions in the accompanying documents says simply to connect it to "any reliable USB connection" in order to charge the internal battery.
My question is: is this acceptable by IEC 60601-1 or 60601-1-2?
The User Instructions say that it is IEC 60601-1 & 60601-1-2 compliant (as does their 510(k) statement).
Is there a clause that I'm missing that allows for such a generic power-source to be specified? If so, how on earth are the other tests (e.g. emissions) reliably tested without a standard power-supply?
Feedback much appreciated!
MM.
Included in the system-kit is simply the device and a USB cable. The charging instructions in the accompanying documents says simply to connect it to "any reliable USB connection" in order to charge the internal battery.
My question is: is this acceptable by IEC 60601-1 or 60601-1-2?
The User Instructions say that it is IEC 60601-1 & 60601-1-2 compliant (as does their 510(k) statement).
Is there a clause that I'm missing that allows for such a generic power-source to be specified? If so, how on earth are the other tests (e.g. emissions) reliably tested without a standard power-supply?
Feedback much appreciated!
MM.