Hi Grace,
Are you asking because the word “Harmonised” appears in the title of the standard? No, it does not mean that it can be used for presumption of conformity to the RED. Basically….. When you work at ETSI, the basic document template you start with… has that wording in the title. You work on the standard (as a Draft) and then it is finally voted and published. When published, it is a “Harmonised Standard” because people agree it is a good standard. The next step is for the EU Commission to decide if it is suitable to demonstrate presumption of conformity to the EU Directive (in this case, the RED). If they think so, then it is added to the OJ. When (if) the standard appears on the OJ, then it does provide presumption of conformity (if you fully, correctly, test to it; and pass) Just because it has the word “Harmonised” on the front page, does not mean it is in the OJ. Actually this is an interesting little thing here. Often, many of us (myself included) will say things like “Is that standard harmonised yet?” or “I used the Harmonised standard”. But, strictly speaking, that is not great terminology. What we really mean is: “Is the standard harmonised and listed on the Official Journal yet?” Technically speaking, a standard can be “Harmonised” when it has been voted and finally published. It is a harmonised standard which is actually listed on the Official Journal, which provides the presumption of conformity. Thanks, Michael. From: Grace Lin [mailto:graceli...@gmail.com] Sent: 02 November 2016 14:39 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] ETSI EN 302 195 V2.1.1 Dear Members, The title on the cover page of the ETSI EN 302 195 V2.1.1 states: " Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU " This standard has not been published on OJ (as October 14, 2016). Can a Declaration of Conformity list this standard to demonstrate compliance with the essential requirements? Thank you very much and I look forward to hearing from you. Best regards, Grace Lin - ---------------------------------------------------------------- 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>
