Thank you Michael,You correctly emphasize the importance of a risk analysis in front of testing and standard selection.
And as well as important the fact that one needs to declare compliance directive, and not to the standard.
But the directives almost always allow a manufacturer to obtain presumption of compliance if
route A (Harmonised Standards / Manufacturers Declaration) is used. The risk analysis is mandatory for
the Notified Body route. I must admit that the different directives are a bit vague on that, and i am
not sure why. I would prefer the risk analysis to be part of every approval route, where the hazards
covered by a HS are not to be further analysed. Gert On 27-11-2018 12:06, Michael Derby wrote:
That’s a good summary from Gert.I think one important thing to remember is that the EU (LVD + EMCD, or RED) approach to compliance is the manufacturer assessing their device in any way possible, to show compliance with a Directive. It’s not a certification to a standard.So, if a product has a risk of causing interference in some way, or causing a safety issue, or being affected by EMC, it should be assessed – regardless if the standard exists yet, or if the standard is harmonised yet, or if the harmonised standard is listed on the Official Journal (OJ) yet.In an ideal situation, all devices would have an applicable harmonised standard which is listed on the OJ for the applicable Directive.If industry then notes that things are changing, the standard gets updated (or a new standard written) and added to the OJ with a reasonable transition period from the old standard.(Or, if the issue is critical, there may be no transition period, or standards can be withdrawn from the OJ).That’s how it should work.However, we’re not in this ideal situation right now, because the standards have not made it onto the OJ for (mostly) legal and administrative reasons.(Also some technical reasons, such as performance criteria, etc.) But this is not a show-stopper.The manufacturer must ascertain which tests or assessments must be carried out on their device, to show that it will not interfere, will not be interfered with, will be safe, etc. Then, do those tests (or assessments) and create their DoC.For example, if a new standard becomes published and there are test cases in there which apply to a product, a manufacturer would not say “I don’t have to do that yet, because that standard is not on the OJ”. The EU approach is declaration to a Directive, not certification to a standard.If a manufacturer knows that their device presents a safety or interference risk which is not covered in any of the standards, published or draft, it does not mean they should ignore it. It means they make their own way to assess it.This is where the manufacturer’s risk assessment becomes so important. It is the starting point for any manufacturer; as a way for the manufacturer to determine which tests they should be doing on their device, and figuring out which standards they should look for.Of course, this is no problem for selling into the EU (it’s easy to pick a standard which is not on the OJ and test to it – and that’s ok in the EU); but I do appreciate that it could be problematic for other non-EU regions who look for compliance to standards on the OJ, and do not understand the subtlety that in the EU that is not mandatory.Michael. *From:*Gert Gremmen [mailto:g.grem...@cetest.nl] *Sent:* 27 November 2018 09:28 *To:* EMC-PSTC@LISTSERV.IEEE.ORG *Subject:* Re: [PSES] EN 55032 Hi All,The document below has been published very recently and shows how and why...https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2018:764:FINIn simple language, the EC court has decided that HS are to be treated as EU-law (Elliot case).This has a lot of consequences. In order to get a _privately originated text_ count as law, the EC has addeda number of conditions that standards need to fulfill. These find their base in the New Legislative Framework.Some of the problems with current texts are: * Not static (by undated references to standards), so "law" changes when referenced standards update, or referenced standards are withdrawn. ( the problem is here also that ESOs are private organisations (ISO,CENELEC, CEN, ISO) can change EU law this way) * Unclear/incomplete technical specifications , link between directives essential requirements and standards technical specifications * Ambiguous test specifications, often introduced by choices a manufacturer can make on its own, so as to avoid testing. * And many more, mostly of a legal interpretation nature.The problem is not that standards are not technically suitable to show presumption of compliance, but that they are not suitable to be used as law.Secondly, the ESOs and national committees are not (yet) fully aware of the consequences and are a bit reluctant.They have been used to create and approve HS on their own, where now the EC takes the lead. This creates problems especially for older standards, that have not been written with the newer standardisation requests in mind.To assess the standards for their suitability a number of HAS-experts have been nominated, and the iterative process of creating suitable harmonised standards is active for about 6 months.Gert Gremmen -- Independent Expert on CE marking Harmonised Standards (HAS-) Consultant @ European Commission for RED and EMC EMC Consultant Electrical Safety Consultant On 27-11-2018 9:43, McBurney, Ian wrote: Hello David. I would be interested in getting more information regarding these legal issues with standards and the court proceedings. Are there any published articles? Regards; Ian McBurney Lead Compliance Engineer Allen & Heath Ltd. Kernick Industrial estate, Penryn, Cornwall. TR10 9LU. UK. Tel: 01326 372070 Email: ian.mcbur...@allen-heath.com <mailto:ian.mcbur...@allen-heath.com> *From:*itl-emc user group <itl...@itl.co.il> <mailto:itl...@itl.co.il> *Sent:* 27 November 2018 06:07 *To:* EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> *Subject:* Re: [PSES] EN 55032 I was informed that almost all the latest versions of standards are being held up over legal issues since a standard was introduced as evidence in a court case. CISPR 11 and others have the same issue. *Regards,* *David Shidlowsky***| Technical Reviewer *Address*1 Bat-Sheva St. LOD 7120101 Israel *Tel*972-8-9186113*Fax* 972-8-9153101 *Mail*: dav...@itlglobal.org <mailto:dav...@itlglobal.org>/dav...@itl.co.il <mailto:dav...@itl.co.il>/e...@itl.co.il ** *rom:*John Woodgate <j...@woodjohn.uk <mailto:j...@woodjohn.uk>> *Sent:* Monday, November 26, 2018 1:29 PM *To:* EMC-PSTC@LISTSERV.IEEE.ORG <mailto:EMC-PSTC@LISTSERV.IEEE.ORG> *Subject:* Re: [PSES] EN 55032 I think it is still held up over legal issues, which may not be resolved any time soon. Best wishes John Woodgate OOO-Own Opinions Only J M Woodgate and Associates www.woodjohn.uk <http://www.woodjohn.uk> Rayleigh, Essex UK On 2018-11-26 09:45, McBurney, Ian wrote: Dear colleagues. Does anyone know if the 2015 edition of the above standard is now listed in the OJEU for the EMC directive? I am struggling to find it on the website. Many thanks in advance. Regards; Ian McBurney Lead Compliance Engineer Allen & Heath Ltd. Kernick Industrial estate, Penryn, Cornwall. TR10 9LU. UK. Tel: 01326 372070 Email: ian.mcbur...@allen-heath.com <mailto:ian.mcbur...@allen-heath.com> Allen & Heath Ltd is a registered business in England and Wales, Company number: 4163451. Any views expressed in this email are those of the individual and not necessarily those of the company. - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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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) 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 <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) 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>> Allen & Heath Ltd is a registered business in England and Wales, Company number: 4163451. Any views expressed in this email are those of the individual and not necessarily those of the company. - ---------------------------------------------------------------- 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) 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. 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-- Independent Expert on CE marking Harmonised Standards (HAS-) Consultant @ European Commission for RED and EMC EMC Consultant Electrical Safety Consultant - ---------------------------------------------------------------- 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>
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