You will receive hundreds of opinions - none will be correct; all will be correct. For the 3d edition of 60601-1, if you can justify the use of ITE-certified equipment in the RMF, go for it...
For the U.S., there may be some problems with the FDA, as there is a disjoint between the 2d edition and adoption of 3d edition. Brian -----Original Message----- From: [email protected] [mailto:[email protected]]On Behalf Of McInturff, Gary Sent: Thursday, October 20, 2011 11:21 AM To: '[email protected]' Subject: Medical equipment versus ITE equipment used in medical facilities List members, I've been looking over the medical directive or at least summaries of it, and EN60601-1 trying to determine what requirements would say that a general purpose keyboard must be evaluated or identified as a medical device or a part of a medical device. The keyboard is designed with bacterial contamination and cleaning in mind. It is completely sealed - not just a cover added over an existing keyboard - and resistant to typical clearers and chemicals use in hospitals. But other than that it's a standard qwerty keyboard with a USB connection to a host. For data collection etc. Typical usage can be at a nurses station or in a patient room as part of a patient records systems. But there is no designed function to specifically help out with patient treatment systems like cat scanners, infusion pumps et al. I suppose there is nothing to prevent one of these system with a USB port to plug in the keyboard. Can someone point me in the direction of the relevant documents that would describe when an ITE item used in a medical environment is required to be evaluated as a medical device. - ---------------------------------------------------------------- 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://product-compliance.oc.ieee.org/ 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]>
