David, The risk assessment you refer to below is not same as the risk assessment referred to in the new LVD (and some other NLF directives). The risk assessment below is specifically aimed at determining whether or not the product presents a risk which is sufficient to warrant post market action, and in particular whether or not a product recall is necessary. This is obviously related to the product design risk assessment which is required before placing the product on the market, but it is not the same thing.
Nick. > On 31 Mar 2016, at 22:09, 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 a product poses a serious risk and should therefore be withdrawn from the 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 <mailto:david.b...@milestone.com> > +1.952.225.6782 > > > > On Thu, Mar 31, 2016 at 11:35 AM, Scott Xe <scott...@gmail.com > <mailto: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 >> <mailto: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 <tel:%2B1%20%28602%29%20883-8039> >> >> From: Charlie Blackham [mailto:char...@sulisconsultants.com >> <mailto:char...@sulisconsultants.com>] >> Sent: Tuesday, March 29, 2016 11:34 PM >> To: Ronald Pickard <ronald.pick...@compoundphotonics.com >> <mailto:ronald.pick...@compoundphotonics.com>>; EMC-PSTC@LISTSERV.IEEE.ORG >> <mailto: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 >> >> <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 >> >> <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/ >> <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 >> <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 >> >> <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 >> >> <http://ec.europa.eu/DocsRoom/documents/13141/attachments/1/translations/en/renditions/native> >> available >> athttp://ec.europa.eu/growth/sectors/electrical-engineering/lvd-directive/index_en.htm >> >> <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 >> >> <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 <tel:%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 >> <mailto:ronald.pick...@compoundphotonics.com>] >> Sent: 29 March 2016 23:46 >> To: EMC-PSTC@LISTSERV.IEEE.ORG <mailto: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 <tel:%2B1%20%28602%29%20883-8039> >> >> - >> ---------------------------------------------------------------- >> 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 <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 >> <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/ >> <http://product-compliance.oc.ieee.org/> can be used for graphics (in >> well-used formats), large files, etc. >> >> Website: http://www.ieee-pses.org/ <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 >> <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 <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 >> <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/ >> <http://product-compliance.oc.ieee.org/> can be used for graphics (in >> well-used formats), large files, etc. >> >> Website: http://www.ieee-pses.org/ <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 >> <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 <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 > <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/ > <http://product-compliance.oc.ieee.org/> can be used for graphics (in > well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ <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 > <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 <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 > <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/ > <http://product-compliance.oc.ieee.org/> can be used for graphics (in > well-used formats), large files, etc. > > Website: http://www.ieee-pses.org/ <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 > <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>
