I'm certainly not a safety expert but I think that Lauren is on the right track here.
The Harmonised Standards are really a tool to show compliance with the standards. But still, regardless of compliance with the standards.... if your product is found to be non-compliant with the Directive, then it is a non-compliant product. The Directive says the product must be safe. The harmonised standards are the tools to help demonstrate that. The basic situation here being that regardless of your safety test results, if the device is unsafe, it's off the market. However, if it was really that extreme, it would imply that the older harmonised standard was found to be insufficient for demonstrating compliance and therefore I would have thought it should have had an immediate withdrawal from the Official Journal. ...unless the thing it failed was some new safety requirement or scenario that had not been considered at all before. Sometimes, completely new situations are realised and must be considered anew, without actually being in a harmonised standard yet. And as we know, just because it's not in a harmonised standard yet, doesn't mean we shouldn't consider it as valid. There are plenty of things which must be assessed by manufacturers independently before they make it into harmonised standards. So, maybe it was unsafe? Michael. Michael Derby Regulatory Engineer ACB Europe -----Original Message----- From: Crane, Lauren [mailto:lauren.cr...@kla-tencor.com] Sent: 31 July 2014 19:09 To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: Re: [PSES] Definition of unsafe product Having tracked development of the proposed Market Surveillance Regulation, and stared for hours at NLF model language now incorporated in LVD... it is frustrating how ambiguous the actionable criteria are for this sort of thing. Authorities may act on "Risk", but there is no risk assessment standard referenced and no threshold of risk required. So regardless of anything to do with standards, an authority's assessment that there is risk could allow empounding, third party testing etc... all on your nickel. The finding of risk is not 100% precluded by the use of harmonized standards (though it may be lessened). I also find it interesting that only the EMCD has language requiring keeping pace with the state of the art. Regards, Lauren -----Original Message----- From: Scott Xe [mailto:scott...@gmail.com] Sent: Thursday, July 31, 2014 12:22 PM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] Definition of unsafe product Recently we received a sales ban from an authority. The authority took a sample from the market and appointed a 3rd party laboratory for verification of LVD conformity. They found a non conformance on construction according to the latest version of safety standard and concluded the product is unsafe. The requirement is new in the latest version and did not appear in the previous version. When our product was verified by the 3rd party test house, it complied with previous version of safety standard but was the latest version of the safety standard at time of testing. The new version was issued 2 months later and has an additional construction requirement. The DoW of previous version of safety standard is in 2016. We are at loss how come they consider our product unsafe with the latest version of the standard during this transitional period. Any previous experience to deal with such authority can be shared? It sounds ridiculous charge on our product. Thanks and regards, Scott - ---------------------------------------------------------------- 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 <emcp...@radiusnorth.net> 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 <emcp...@radiusnorth.net> 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 <emcp...@radiusnorth.net> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
