IEC 60601-1-2 RF wireless technology

primavesvera

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#1
Hi all,

Our clients are buying new tablets and one question popped up - do they need to have their tablets tested per IEC 60601-1-2.

Our software has an interface with tablets, however, they use those tablets for other purposes as well.

Do they still need to be tested per IEC 60601-1-2 or is it enough they are compliant with applicable radio frequency legislation, like FCC Part 15 in the US?

Thanks.
 
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Peter Selvey

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#2
The tablets are (probably) not medical devices. Regulations are based on the intended purpose of the device by the company that makes the device.

If they specify the tablet is specifically for medical use, then it becomes a medical device. However, it is more likely these are just run of the mill tablets with some medical related software related being installed. While the software is a medical device, the tablet remains non-medical. Which means the tablet just needs to comply with the normal standards/EMC requirements for a tablet.
 
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