Hello Amund, I agree that you should be CE Marking these devices, as they are placed on the market for normal use.
If there is any flexibility to be found, then maybe it is in your application of the Directive. For example, the typical way to comply with the Directive would be to fully apply the tests within the harmonised standards and go through the whole process that way. That gives you your presumption of conformity. If your “normal use by normal end users” is just as it sounds; then fully testing to the harmonised standards does indeed sound like the best idea. But if you really mean that a select few people will be using the products in controlled environments, and the manufacturer has some knowledge or control over that environment; then maybe you can look at ways to meet the directive without doing all the testing. After all, if one of the purposes of your trial is to keep the product within the hands of a trials engineer and see if the engineer can use it daily without it being killed by ESD, then fully complying with the ESD tests beforehand might not be necessary. …if you see what I mean. I hope this makes some sense. Michael. From: Amund Westin [mailto:am...@westin-emission.no] Sent: 07 March 2016 08:56 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Prototype batch ... CE applies? Case: Making the first prototype batch of equipment (covered by EMC and LVD). The limited numbers of items will be placed on the market for functional testing by normal end-users, before normal production starts. Of course the CE applies, even for these prototype items. I cannot find any statement in the directive text or in the Blue Guide 2014, which gives granted exemption from the requirements. Exemption in the EMC directive for «Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes» does not match this actual case. So, CE applies. Agree? Best regards Amund - ---------------------------------------------------------------- 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>
