J
Hi all,
We are Class IIA medical device according to MDD, currently using push button switch as E- stop. This device has a pump that will rotate in clockwise & anti-clockwise direction, a tube rolled over the pump is connected to the patient.
Do we need a separate E-stop switch as per the IEC 60601-1? or push button switch sufficient(simply stops pumping)?
we are in process of going for IEC testing as well as UL.
Pl clarify...
We are Class IIA medical device according to MDD, currently using push button switch as E- stop. This device has a pump that will rotate in clockwise & anti-clockwise direction, a tube rolled over the pump is connected to the patient.
Do we need a separate E-stop switch as per the IEC 60601-1? or push button switch sufficient(simply stops pumping)?
we are in process of going for IEC testing as well as UL.
Pl clarify...