Xray and Infrared Radiation Debacle

F

flyingfrisbee

#1
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
 
Elsmar Forum Sponsor
#2
If you have a look at the informative annex A, with regard to 10.1.1, it identifies VDUs as being a possible source of unintentional x-ray radiation. If you do not have such a component (or similar) then I think you would be justified as claiming this clause as 'Not Applicable'. That's what I do!

For 10.6, the requirement is for infrared to be considered in your risk process. So, if you can say that the infrared is separated / shielded / too low power for any harm to come to the patient then you probably have it covered.
 
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