Risk assessments are not new and it’s a requirement of the current Machinery Directive from 2006 and probably for some time before. A principle HS for the MD is EN ISO 12100:2010. Many of the basic concepts can be applied to non-machinery. I’d think that standard or one similar would become an HS for the LVD.
In my experience the test labs that do certification work do not do risk assessment, it is a responsibility of the manufacturer. They will however review your risk assessment when certifying to other standards. The test labs I have worked with typically are set up with three independent internal divisions, one that does certifications to standards, one that does factory inspections (OSHA NRTLs), and one that will do design consulting services. As was explained to me, these divisions are intentionally separated and do not work with each other as to maintain their independent functions and avoid conflict of interest. I imagine the design consulting services division of some test labs would offer risk assessment/reduction services, I have known other companies that have contracted that out. -Dave From: Scott Xe [mailto:[email protected]] Sent: Thursday, March 31, 2016 12:36 PM To: [email protected] Subject: Re: [PSES] EU's new approach directive transitions 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 <[email protected]<mailto:[email protected]>> 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:[email protected]] Sent: Tuesday, March 29, 2016 11:34 PM To: Ronald Pickard <[email protected]<mailto:[email protected]>>; [email protected]<mailto:[email protected]> 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 athttp://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 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:[email protected]] Sent: 29 March 2016 23:46 To: [email protected]<mailto:[email protected]> 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 <[email protected]<mailto:[email protected]>> 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 <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]<mailto:[email protected]>> 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 <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]<mailto:[email protected]>> 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 <[email protected]<mailto:[email protected]>> Mike Cantwell <[email protected]<mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected]<mailto:[email protected]>> David Heald <[email protected]<mailto:[email protected]>> - ---------------------------------------------------------------- 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 <[email protected]> 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 <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
