Derek Electrical safety requirements will as IT equipment 60950, for protection of the doctor. But there may be additional patient safety issues associated with the accuracy of displayed images, if a diagnosis depends on this. Software is a critical component here. IEC62304 is an appropriate standard to control software development.
Best regards Andy Clifford Conformance Ltd - Product safety, approvals and CE-marking consultants The Old Methodist Chapel, Great Hucklow, Buxton, SK17 8RG England Tel. +44 1298 873800, Fax. +44 1298 873801, www.conformance.co.uk Registered in England, Company No. 3478646 From: Derek Walton [mailto:[email protected]] Sent: 25 September 2009 14:54 To: [email protected] Subject: [PSES] 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]>
