Derek, The key to knowing how to relate to this type of product is 'intended use'.
I have inserted below the definition of a medical device from the Canadian Food and Drugs Act. >From your description, it does not appear to be a medical device, except if the software includes any elements which may affect diagnosis, for example if there is any image processing of CT scans. In this case just the software is considered a medical device and is covered by the Medical Device Regulations. Here is the definition from the Act: "device" means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, (b) restoring, correcting or modifying a body function or the body structure of human beings or animals, (c) the diagnosis of pregnancy in human beings or animals, or (d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, and includes a contraceptive device but does not include a drug; Regards, Jon Griver http://www.601help.com The Medical Device Designer's Guide to IEC 60601-1 From: [email protected] [mailto:[email protected]] On Behalf Of Derek Walton Sent: 25 September 2009 16:54 To: IEEE EMC Discussion Group Subject: Canadian Medical Device, maybe Good day all, I have been asked by a client to look into what requirements exist for a device that will be installed on the wall of a Doctors office in Canada. It has no patient contact, and essentially is a PC for recalling and displaying patient information. I can find loads of requirements for devices that attach to patients, or attach indirectly for patients, but nothing thats benign like this. Can anyone suggest what requirements exist please? Thanks, Derek Walton L F Research - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]> - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
