On 5/29/2008, Ronald Wellman wrote:
The following web page lists recognized standards:
http://www.hc-sc.gc.ca/dhp-mps/md-im/s
andards-normes/md_rec_stand_im_norm_lst_2_e.html
Hi Ron:
Thanks. In reviewing the information at this link, I conclude the following:
1) Yes, at least some medical equipment approved in Canada under at least some
versions of IEC 60601 is subject to EMC immunity tests.
2) The specifics of determining whether a home medical device must meet
certain EMC immunity tests will likely require some digging.
3) There has apparently been some industry protest to Canada's recent
imposition of the Third editions of IEC 60601-1 and IEC 60601-1-2. In
response to that protest, Canada has extended the date by which the transition
to the new editions must take place (December 2008).
Do you know whether the problems with the Third Edition relate to EMC
immunity, and if so what the change was?
Also, if anyone can comment on how medical equipment is classified for IEC
60601, I would appreciate it. My guess is that a device intended for home use
*might* be subject to less stringent requirements than a device intended for
use in a hospital.
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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