If a patient can have access to the keyboard, it needs to meet 60601-1. Generally if it is located in a patient’s room near the bed, they are considered to have access to it.
Patty Knudsen Teradata Corporation PH: 858-485-3748 patricia.knud...@teradata.com From: McInturff, Gary [mailto:gary.mcintu...@esterline.com] Sent: Thursday, October 20, 2011 11:21 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] 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. Thanks - ---------------------------------------------------------------- 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 <emc-p...@ieee.org> 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 <emcp...@radiusnorth.net> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org> David Heald <dhe...@gmail.com> - ---------------------------------------------------------------- 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 <emc-p...@ieee.org> 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 <emcp...@radiusnorth.net> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org> David Heald <dhe...@gmail.com>
