On 5/30/2008, John Woodgate wrote:
Is the modem a separate piece of equipment? What I'm thinking of is the
problem of combining access to the POTS network, regarded as an unintentional
lightning conductor, with a medical device that contacts the patient. I mean,
the patient touching the controls of the device, not the cuff and tube, which
are obviously non-conducting (I hope!).
Hi John:
Yes, the modem is embedded within the enclosure of the device. By itself,
this is not a big problem because in principle, any desired level of isolation
can be provided in the phone line interface.
The issue that has me confused at present is what EMC immunity requirements,
if any, apply to such a device for approvals in Canada. This particular
product is already in the market in the USA, but I have been told that it
"can't be approved in Canada" because it doesn't meet certain EMC immunity
requirements. I don't presently have access to all the relevant information
and the history on the product, but the assertion that there was something
unique about approvals in Canada (as opposed to the USA) surprised me. I
thought I would ask my colleagues on this discussion board to help educate me
on the topic.
What I gather from Ron Wellman's response is that at least some medical
devices must pass certain EMC immunity tests for approval in Canada. The
standards that Canada is referencing are all various editions of IEC 60601 and
its derivatives. This leads me to some (possibly stupid) questions about the
IEC 60601 family of standards:
1) How long has IEC 60601 called out EMC immunity for medical devices?
2) Have the EMC immunity requirements in the Third Edition of IEC 60601 become
more stringent than in previous editions? Canada has apparently delayed the
phase-out of the earlier editions in response to unspecified complaints from
industry regarding new requirements in the Third Edition.
3) For a device that is used in the home to monitor certain parameters (such
as blood pressure) and report that data to a server via the phone line, is
there some flexibility to classify the equipment as ITE instead of a medical
device?
I apologize in advance for asking such basic questions, but I work mostly with
ITE and I know those standards much better. I am less familiar with the IEC
60601 family of standards.
Thanks.
Joe Randolph
Telecom Design Consultant
Randolph Telecom, Inc.
781-721-2848 (USA)
[email protected]
http://www.randolph-telecom.com <http://www.randolph-telecom.com/>
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