Right. Use the clause 4.5 of the standard and give a rationale in the Risk Management file.
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]<mailto:[email protected]> www.itl.co.il<http://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: Momcilovic, Nick (GE Healthcare) [mailto:[email protected]] Sent: Thursday, October 11, 2012 7:05 PM To: [email protected] Subject: Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units The data must be able to be displayed in SI units but it does not prohibit the equipment to display other units of measure. At least that is my understanding of this requirement. Regards, Nick Momcilovic From: [email protected] [mailto:[email protected]] On Behalf Of Carl Newton Sent: Thursday, October 11, 2012 8:56 AM To: [email protected] Subject: AAMI version of 60601-1 3rd ed - requirement for SI Units Group, Does anyone have experience with the AAMI version of 60601-1, 3rd edition and clause 7.4.3? This clause requires that measurement parameters be in SI units. I'm working on a therapeutic exercise device which requires patients to enter weight as a step in the setup process. American patients will be befuddled if required to enter kg. Anyone aware of a loophole? I'm working with the EN edition. Thanks, Carl - ---------------------------------------------------------------- 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]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. 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]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[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]<mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. 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]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[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.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. 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]>
