Hi Scott, I don't see the risk assessment replacing any requirement to supply a test report. My assertion is that any risk assessment we might undertake should be at least as rigorous as the one that a member state's enforcement body might do.
You can search for Decision 2010/15/EU here: http://eur-lex.europa.eu/homepage.html?locale=en Best regards, David *David K. Bell* Senior Regulatory Compliance Engineer Milestone AV Technologies david.b...@milestone.com +1.952.225.6782 On Fri, Apr 1, 2016 at 9:18 AM, Scott Xe <scott...@gmail.com> wrote: > Dear David, > > Will the EU enforcement body use this format to inquire the LVD compliance > to the suppliers in the future in replacement of getting the test report to > the harmonised standard now? Where to get a copy of the Decision > 2010/15/EU? > > Regards, > > Scott > > On 1 Apr, 2016, at 5:09 am, David K Bell <davidkbell...@gmail.com> wrote: > > Scott, > > With regard to the risk assessment requirement in the Directives revised > under the New Legislative Framework (NLF): > > This excerpt is from a discussion of the proposed EU Consumer Product > Safety Regulation (CPSR): > > The European Commission will undertake a risk analysis of the product to > determine whether the product is likely to pose a 'serious' risk. The > default risk analysis methodology to be used is the already established EU > Risk Assessment Methodology (Decision 2010/15/EU), by which products can be > assessed and classified as posing a 'Low', 'Medium', 'High' or 'Serious' > risk. If this risk assessment methodology is not appropriate for the > particular product, the Commission must give a detailed description of the > methodology used in its place. > > > Appendix 5 of Decision 2010/15/EU on pages 33—64 covers Risk Assessment. > This is the methodology that a EU enforcement body would use to determine > if a product poses a serious risk and should therefore be withdrawn from > the market and notified to other EU member states via the EU RAPEX rapid > alert system. Any risk analysis that we do to satisfy the requirements of > the new LV and EMC Directives should be no less rigorous. > > Best regards, > > *David K. Bell* > Senior Regulatory Compliance Engineer > Milestone AV Technologies > > david.b...@milestone.com > > +1.952.225.6782 > > > On Thu, Mar 31, 2016 at 11:35 AM, Scott Xe <scott...@gmail.com> wrote: > >> There are two major changes in new LVD. One is the risk assessment that >> is to be the obligation for the manufacturers. The other one is that the >> DoC is required to have object of declaration. >> >> The risk assessment is unclear how to do it and any reference to follow. >> Currently there is few testing laboratories to provide such service to the >> manufacturers. Hope there is harmonised standard and/or guidance for >> compliance in near future. >> >> Scott >> >> >> On 31 Mar, 2016, at 1:50 am, Ronald Pickard < >> ronald.pick...@compoundphotonics.com> wrote: >> >> Hi Charlie, >> Thank you for your reply along with those linked references. Those ETSI >> links provide projected target dates for approval and availability for the >> new/revised standards being drafted for the RED, which are generally >> targeted to be complete by the 13-Jun-2017 effectivity date for the RED. >> Kudos to ETSI for that work. >> >> Best regards, >> >> *Ron Pickard* >> Regulatory Compliance Engineer >> *Compound Photonics* >> D | +1 (602) 883-8039 >> >> *From:* Charlie Blackham [mailto:char...@sulisconsultants.com >> <char...@sulisconsultants.com>] >> *Sent:* Tuesday, March 29, 2016 11:34 PM >> *To:* Ronald Pickard <ronald.pick...@compoundphotonics.com>; >> EMC-PSTC@LISTSERV.IEEE.ORG >> *Subject:* RE: EU's new approach directive transitions >> >> Ron >> >> Few short answers: >> >> · No sign of that happening at all and I cannot see it happening >> · No, existing Directives are repealed by the new Directives on >> the dates indicated, but you may wish to look at Recommended format for >> DoC that can reference existing and new Directives, >> http://ec.europa.eu/DocsRoom/documents/14886/attachments/1/translations/en/renditions/native >> (referenced from >> http://ec.europa.eu/growth/sectors/electrical-engineering/emc-directive/index_en.htm >> ) >> · ETSI are working hard on updating over 150 standards, some >> more information available: >> o https://docbox.etsi.org/Workshop/2015/201511_RED-WORKSHOP/ for >> presentations from November workshop >> o Work program on radio standards: >> http://webapp.etsi.org/ena/cvp.asp?search=RADIO and a number of RED >> standards have a been published or are available as final draft >> o Work program on EMC standards: >> http://webapp.etsi.org/ena/cvp.asp?Search=emc&Status=&Directive=&submit1=Get+Work+Items >> · Lists of HS for current standards can be used for new >> Directives until new lists are published as per relevant article in the >> directive such as article 27 of the 2014/35/EU LVD. >> · So far I’m aware of: >> o LVD guidance on transition to new LVD, >> http://ec.europa.eu/DocsRoom/documents/13141/attachments/1/translations/en/renditions/native >> available at >> http://ec.europa.eu/growth/sectors/electrical-engineering/lvd-directive/index_en.htm >> o RED guidance is being worked on, but RED is not mandatory until 2017 >> so there is more time for this. >> http://ec.europa.eu/DocsRoom/documents/11983/attachments/1/translations/en/renditions/pdf >> provides guidance on transitions for equipment moving into and out of >> R&TTE/RED. >> · No one is expecting anything. >> >> Regards >> Charlie >> >> *Charlie Blackham* >> *Sulis Consultants Ltd* >> *Tel: +44 (0)7946 624317 <%2B44%20%280%297946%20624317>* >> *LinkedIn: **uk.linkedin.com/in/charlieblackham/* >> <http://uk.linkedin.com/in/charlieblackham/> >> *Web: www.sulisconsultants.com <http://www.sulisconsultants.com/>* >> Registered in England and Wales, number 05466247 >> >> >> >> *From:* Ronald Pickard [mailto:ronald.pick...@compoundphotonics.com >> <ronald.pick...@compoundphotonics.com>] >> *Sent:* 29 March 2016 23:46 >> *To:* EMC-PSTC@LISTSERV.IEEE.ORG >> *Subject:* [PSES] EU's new approach directive transitions >> >> Hi to all, and especially to those that are knowledgeable of the EU’s >> processes on this subject, >> >> I know that this subject has been discussed before without resolution, >> but the time is nearing the end of the transition periods of the EU’s new >> EMC, LV and RE directives and I (I’m guessing I’m not alone) was wondering >> if anyone knows what the EU intends to do when these directives reach >> beyond their respective transition periods with no listed harmonized >> standards? >> >> - Will the directives’ transition dates be extended? >> - Will a presumption of conformity continue to exist to the repealed >> directives after the transition period? >> - What is ETSI’s timeline to revise its harmonized standards to reflect >> these new directives? >> - Will harmonized standards under the current respective directives >> continue to be utilized under the new directives (probable)? >> - Is there any EU guidance that addresses the above questions? If so, >> please provide a link(s). >> - Will the EU pull a rabbit out of its hat at the last moment? >> >> Can anyone shed any light on this? >> >> I look forward to your reply. >> >> Best regards, >> >> *Ron Pickard* >> Regulatory Compliance Engineer >> *Compound Photonics* >> D | +1 (602) 883-8039 >> >> - >> ---------------------------------------------------------------- >> >> 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) <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> >> Mike Cantwell <mcantw...@ieee.org> >> >> For policy questions, send mail to: >> Jim Bacher <j.bac...@ieee.org> >> David Heald <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) <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> >> Mike Cantwell <mcantw...@ieee.org> >> >> For policy questions, send mail to: >> Jim Bacher <j.bac...@ieee.org> >> David Heald <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) <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> >> Mike Cantwell <mcantw...@ieee.org> >> >> For policy questions, send mail to: >> Jim Bacher <j.bac...@ieee.org> >> David Heald <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>
