EMC IEC 60601-1-2 Testing for General Wireless Connections

Hoping someone can shed light on the following situation:

We are considering developing a device that is intended to communicate wirelessly with an off-the-shelf computer.

Medical Device --> bluetooth --> Consumer Computer (running MD software)

Can this be tested to 60601-1-2 without having to also specify and test the consumer computer?

 

Hi Mark,

I have done the EMC tests on a device with wireless communications, but this was with a device where the two parts together constituted the device, rather than comms to a "general purpose" computer.

I would expect that the testing would need to involve the computer and communications, but if each end used properly licensed and approved Bluetooth modules, the results could be considered to apply to all "general purpose" computers, rather than only applying to one make-and-model.

It is worth remembering that there are exclusion bands available, around your operating frequency, for both the emissions and the immunity tests.

I understand that the EMC test houses are seeing more and more equipment with wireless comms, of one kind or another. So this sort of issue is quite common. Hopefully, they will know how to avoid issues with the emissions from the computer and then the computer being affected by the immunity tests, both of which should be thought of as outside the device tests.

 

I made several inquiries last year, and this was the position the test-labs I'd contacted have taken.
...which, unfortunately, is tantamount to testing individual makes-and-models, because the bluetooth modules in consumer computers are not themselves 60601-1-2 tested...

I don't know how this will be tenable moving forwards though, what with all the mobile technologies.

For example, if our device connected with smart-phones via bluetooth, would there be an onus to test every individual model of phone (not to mention re-testing with every obsolescence cycle)? This would be ridiculous!

 

I would not expect a module to be tested to 60601-1-2, but they are licensed and tested to other standards.

For instance this one:
http://ie.farnell.com/ls-research/450-0106c/mod-bluetooth-tiwi-ub1-rf-castellation/dp/2356773

is FCC approved (as well as European and Canadian approvals). If you were communicating to a PC you could use a BlueTooth 'dongle'. As such, you would have 'control' over both ends of your communications and would not have to be concerned about what model of computer was being used.

If you were reliant upon in-built BT, such as with mobile devices, it may not be so straightforward. But it is worth remembering that you are not testing the mobile device. Perhaps your 'worst case' scenario would be having to repeat a small sub-set of the immunity tests to prove that the choice of handset does not have influence on the continued successful communications. Much there would depend upon what elements of performance that you' as manufacturer, has decided should be treated as 'Essential Performance' and what degradations you regard as being acceptable.