Hi Gary, According with the philosophy of the 3rd edition of IEC 60601-1 an ITE item is accepted in medical electrical equipment if is located in the USER part.
The subject keyboard needs to be evaluated globally with the whole equipment for the relevant clauses of IEC 60601-1. Pending the intended use of the medical device additional means of protection can be added to the ITE part. This addition should be result of the Risk Management process. I hope that the above can help. Regards, Steli Steli Loznen, M.Sc.,SM-IEEE Q.A. and Certification Manager Convener of IEC/TC62/SC62A/WG17 I.T.L (Product Testing) Ltd. 1, Bat Sheva St., POB 87 LOD 71100, ISRAEL Tel: 972-8-9153100 Fax: 972-8-9153101 Mobile: 972-54-7245794 E-mail: [email protected] www.itl.co.il _______________________________________________ This e-mail message may contain privileged or confidential information. If you are not the intended recipient, you may not disclose, use, disseminate, distribute, copy or rely upon this message or attachment in any way. If you received this e-mail message in error, please return by forwarding the message and its attachments to the sender. ________________________________ From: McInturff, Gary [mailto:[email protected]] Sent: Thursday, October 20, 2011 8:21 PM To: [email protected] 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 <[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]> - ---------------------------------------------------------------- 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]>
