The following web page lists recognized standards:
http://www.hc-sc.gc.ca/dhp-mps/md-im/st
ndards-normes/md_rec_stand_im_norm_lst_2_e.html
where the following apply to EMC:
IEC 60601-1-2 Ed. 2.0, Ed. 2.1 : 2004-11-01
Medical electrical equipment – Part 1-2: General requirements for safety –
Collateral Standard – Electromagnetic Compatibility – Requirements and
Tests
CAN/CSA-C22.2 NO. 60601-1-2A-03 (R2006)
Medical electrical equipment - Part 1-2: General requirements for safety -
Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
(Adopted Amendment 1:2004 to IEC 60601-1-2:2001)
IEC 60601-1-2 Ed.3.0 March 2007
Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic compatibility
- Requirements and Tests
Best regards,
Ron Wellman
-----Original Message-----
From: [email protected] [mailto:[email protected]]On Behalf Of Joe
Randolph
Sent: Wednesday, May 28, 2008 9:17 PM
To: Emc-Pstc
Subject: EMC immunity requirements for medical device in Canada?
Hello All:
I am looking at a device that is used in the home for monitoring various
medical parameters (such as blood pressure). This device uploads data to a
server via a modem, using a regular phone line.
There is some uncertainty whether this device should be treated as ITE
or as
medical equipment. If it is ITE, there are no EMC immunity requirements for
Canada such as static discharge, radiated immunity, EFT, etc.
If the device is classified as medical equipment, are there EMC immunity
requirements for Canada? If so, what standards are called out?
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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