Re: [PSES] 61010 vs 60601
Thank to those who responded. I will offer options and recommendations to the client and will guide their decision taking some of your guidance into account.Stay healthy, stay safe.Sent from my Verizon, Samsung Galaxy smartphone Original message From: sgbrody Date: 5/21/20 3:15 PM (GMT-05:00) To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] 61010 vs 60601 Fellow gurus,I have a client who has a product certified to 60601-1 and now they have a non-medical application and are looking for 61010-1.Can the medical cert and report be leveraged towards 61010-1 or a new report be started from scratch?Same for EMC.Thanks,Sent from my Verizon, Samsung Galaxy smartphone - 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://www.ieee-pses.org/list.html (including how to unsubscribe) 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] 61010 vs 60601
Steve, Everything is negotiable but it sounds like a good approach. 61010-1 is designed for commercial electronic equipment and is adequate for non-patient connected equipment in most respects. Do you need a single certification (only CE or US or?) or will multiple certifications (e.g. CE and US) be needed? Multiple certs complicates the picture slightly as more standards docs need to be compared but should still work ok. To determine how much of the present safety certification can be carried to the new certification, a discussion should be had with the certifying lab folks; you’ll probably have to work with them to get the knowledgeable technical folks from each group in the same room go thru the present report together and agree on what can be used and what is plowing new ground. (The 2nd project like this will be easier for all concerned; the work is quite siloed in the test labs.) For EMC there are probably a couple of options to explore. The key issue revolves around the fact that medical equipment requires very low touch current levels compared to commercial equipment so the EMC filters don’t divert as much current to ground which may leave a messier conducted emissions level feeding back into the line; what does the commercial market expect in this regard. As I remember, the 61010 group has written a special EMC standard for their medical applications as the medical facility doesn’t want to have non-medical equipment interfere with the medical equipment when operated in the same environment. Again, you can tear and compare the requirements with the EMC lab folks and decide what additional testing is needed to cover your bases. Sounds like and interesting project. Good luck. :>) br, Pete Peter E Perkins, PE Principal Product Safety & Regulatory Affairs Consultant PO Box 1067 Albany, ORe 97321-0413 503/452-1201 IEEE Life Fellow IEEE PSES 2020 Distinguished Lecturer <mailto:p.perk...@ieee.org> p.perk...@ieee.org Entropy ain’t what it used to be From: sgbrody Sent: Thursday, May 21, 2020 12:16 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] 61010 vs 60601 Fellow gurus, I have a client who has a product certified to 60601-1 and now they have a non-medical application and are looking for 61010-1. Can the medical cert and report be leveraged towards 61010-1 or a new report be started from scratch? Same for EMC. Thanks, Sent from my Verizon, Samsung Galaxy smartphone - 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://www.ieee-pses.org/list.html (including how to unsubscribe) <http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas mailto:sdoug...@ieee.org> > 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://www.ieee-pses.org/list.html (including how to unsubscribe) 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] 61010 vs 60601
WHICH “61010 vs 60601” – EU CE requirements OR US/Canadian (OR “somewhere else”) requirements because they likely “differ in the details”?:) John E Allen W.London, UK From: sgbrody Sent: 21 May 2020 20:16 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] 61010 vs 60601 Fellow gurus, I have a client who has a product certified to 60601-1 and now they have a non-medical application and are looking for 61010-1. Can the medical cert and report be leveraged towards 61010-1 or a new report be started from scratch? Same for EMC. Thanks, Sent from my Verizon, Samsung Galaxy smartphone - 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://www.ieee-pses.org/list.html (including how to unsubscribe) <http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas mailto:sdoug...@ieee.org> > 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://www.ieee-pses.org/list.html (including how to unsubscribe) 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] 61010 vs 60601
Hi Steve: I would think that 60601-1 certification is sufficient, and that 61010-1 is not needed. After all, 60601-1 *should be* the more severe standard. Some years ago, I certified a printer that was certified as EDP as medical equipment too. Easy. If you ask a certification house, they may look at the 60601-1 certification report, but they will probably start from scratch as they will claim that they don’t know whether the requirements are the same or equivalent. Especially since the medical and measurement product groups at the certification house are different. And, more revenue. I recently bought a S-VHS recorder/player that was for medical use and was UL-medical-equipment-certified that included a label “not for patient use.” I’m using it in my home despite not being certified the same as my other TV equipment. I think its okay. Stay safe, and best regards, Rich From: sgbrody Sent: Thursday, May 21, 2020 12:16 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] 61010 vs 60601 Fellow gurus, I have a client who has a product certified to 60601-1 and now they have a non-medical application and are looking for 61010-1. Can the medical cert and report be leveraged towards 61010-1 or a new report be started from scratch? Same for EMC. Thanks, Sent from my Verizon, Samsung Galaxy smartphone - 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://www.ieee-pses.org/list.html (including how to unsubscribe) <http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas mailto:sdoug...@ieee.org> > 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://www.ieee-pses.org/list.html (including how to unsubscribe) 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] 61010 vs 60601
If you mean “certified” as in it carries a 3rd party certification mark, then I expect you’re looking at a full re-test If you’re considering CE marking, then you may already have all the test data that you need, but you should do a further assessment to check that the product continues to meet essential requirements of the Directive – things such as: * Are the use cases different? (Altitude / temperature / outdoor use / untrained personnel etc.) * Is the EMC environment more stringent in any way – such as heavy industrial location? Different operating modes or performance criteria for new application? Best regards Charlie Charlie Blackham Sulis Consultants Ltd Tel: +44 (0)7946 624317 Web: https://sulisconsultants.com/ Registered in England and Wales, number 05466247 From: sgbrody Sent: 21 May 2020 20:16 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] 61010 vs 60601 Fellow gurus, I have a client who has a product certified to 60601-1 and now they have a non-medical application and are looking for 61010-1. Can the medical cert and report be leveraged towards 61010-1 or a new report be started from scratch? Same for EMC. Thanks, Sent from my Verizon, Samsung Galaxy smartphone - 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://www.ieee-pses.org/list.html (including how to unsubscribe)<http://www.ieee-pses.org/list.html> List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas mailto:sdoug...@ieee.org>> 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://www.ieee-pses.org/list.html (including how to unsubscribe) 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] 61010 vs 60601
Fellow gurus,I have a client who has a product certified to 60601-1 and now they have a non-medical application and are looking for 61010-1.Can the medical cert and report be leveraged towards 61010-1 or a new report be started from scratch?Same for EMC.Thanks,Sent from my Verizon, Samsung Galaxy smartphone - 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://www.ieee-pses.org/list.html (including how to unsubscribe) 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:
