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Hi,
Pardon my naivet?. I am pretty much all self taught at this stuff.
My small biomedical engineering company in Hanoi, Vietnam is testing our CPAP for CE marking as our first device.
I was wondering if we are required to test the device for xray radiation in accordance with clause 10.1.1 of IEC 60601-1, since our device is not intended to produce xray radiation. I am not sure whether it "might" produce xray radiation or not.
Also, I was wondering if we need to do an infrared radiation test in accordance with 10.6. The device has heaters for tubing, an applied part and for humidification, not applied. If we need one, how is this different from temperature test in accordance with risk management.
Take care
Pardon my naivet?. I am pretty much all self taught at this stuff.
My small biomedical engineering company in Hanoi, Vietnam is testing our CPAP for CE marking as our first device.
I was wondering if we are required to test the device for xray radiation in accordance with clause 10.1.1 of IEC 60601-1, since our device is not intended to produce xray radiation. I am not sure whether it "might" produce xray radiation or not.
Also, I was wondering if we need to do an infrared radiation test in accordance with 10.6. The device has heaters for tubing, an applied part and for humidification, not applied. If we need one, how is this different from temperature test in accordance with risk management.
Take care
