These OJ list updates are often long delayed. In fact, a 2016 standard might not yet have completed the endorsement process in CEN. With best wishes DESIGN IT IN! OOO – Own Opinions Only <http://www.jmwa.demon.co.uk/> www.jmwa.demon.co.uk J M Woodgate and Associates Rayleigh England Sylvae in aeternum manent. From: Stephen Whalen [mailto:scwha...@bellsouth.net] Sent: Wednesday, January 18, 2017 3:17 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] ISO 13485-2016 All, I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval? https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards, Stephen - ---------------------------------------------------------------- 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 <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 <sdoug...@ieee.org <mailto:sdoug...@ieee.org> > Mike Cantwell <mcantw...@ieee.org <mailto:mcantw...@ieee.org> > For policy questions, send mail to: Jim Bacher <j.bac...@ieee.org <mailto:j.bac...@ieee.org> > David Heald <dhe...@gmail.com <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 <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) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
