Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units
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: st...@itl.co.il<mailto:st...@itl.co.il> 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:nick.momcilo...@ge.com] Sent: Thursday, October 11, 2012 7:05 PM To: EMC-PSTC@LISTSERV.IEEE.ORG 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: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carl Newton Sent: Thursday, October 11, 2012 8:56 AM To: EMC-PSTC@LISTSERV.IEEE.ORG 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 mailto:emc-p...@ieee.org>> 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 mailto:emcp...@radiusnorth.net>> Mike Cantwell mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher mailto:j.bac...@ieee.org>> David Heald mailto: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 mailto:emc-p...@ieee.org>> 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 mailto:emcp...@radiusnorth.net>> Mike Cantwell mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher mailto:j.bac...@ieee.org>> David Heald mailto: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 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 Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units
Thanks very much to all of you who responded. I now have a path to pursue. Carl On Thu, Oct 11, 2012 at 9:55 AM, Carl Newton wrote: > 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 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 Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
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: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Carl Newton Sent: Thursday, October 11, 2012 8:56 AM To: EMC-PSTC@LISTSERV.IEEE.ORG 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 mailto:emc-p...@ieee.org>> 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 mailto:emcp...@radiusnorth.net>> Mike Cantwell mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher mailto:j.bac...@ieee.org>> David Heald mailto: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 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 Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units
Carl, What if it is addressed in your RMF? Considering it is ANSI/AAMI instead of IEC/EN, and the intended market, I would think this would be an area you could use the RMF and address it that way. If needed you could possible address this using Clause 4.5 (although, this might be a bit of a stretch here.) I would also check with your NB or safety lab that you use and see what they have to say. Regards, Josh Joshua Wiseman Taylor Company A division of Carrier Commercial Refrigeration, Inc From: Carl Newton [mailto:emcl...@gmail.com] Sent: Thursday, October 11, 2012 8:56 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] 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 mailto:emc-p...@ieee.org>> 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 mailto:emcp...@radiusnorth.net>> Mike Cantwell mailto:mcantw...@ieee.org>> For policy questions, send mail to: Jim Bacher mailto:j.bac...@ieee.org>> David Heald mailto: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 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 Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
Re: [PSES] AAMI version of 60601-1 3rd ed - requirement for SI Units
In message , dated Thu, 11 Oct 2012, Carl Newton writes: American patients will be befuddled if required to enter kg. So would many British patients! -- OOO - Own Opinions Only. See www.jmwa.demon.co.uk The longer it takes to make a point, the more obtuse it proves to be. John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK - 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 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 Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald:
[PSES] 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 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 Mike Cantwell For policy questions, send mail to: Jim Bacher: David Heald: