John W has this crucial distinction right, and it seems to be causing a lot of confusion:
For a prosecution, alleging that a product is unsafe under LVD (as transcribed into the relevant national law), to succeed, the following things have to happen: 1) The prosecutor has to show, beyond reasonable doubt, that the product fails to meet the Essential Health and Safety Requirements of the Directive. There is no offence of "failing to comply with a standard", be it harmonised or otherwise. 2) If therefore they have used an identified non-compliance with a standard as the basis for bringing a case, they have to further demonstrate to the court that the nature or extent of the non-compliance is sufficiently serious to breach the EHSRs. The burden of proof lies with them, and it's often quite difficult. Say, for example, that a standard calls up a flash (hi-pot) test at 3750V, and the product fails there, but passes at 3000V. What practical hazard in service is the court going to be persuaded actually exists, given that this lower figure is still over 12x mains voltage? Is pointing out that this has happened because a clearance distance is a bit below standard on a particular sample because of some rather over-eager hand soldering enough to convict? In other words, compliance with (the correctly selected) harmonised standard gives a presumption of directive conformity, but non-compliance does not give a presumption of non-conformity. 3) But even if the prosecution succeeds at that stage, the presumption (NOT assumption) of conformity has another use. There is an available defence of "due diligence", i.e. that the defence took all reasonable steps to avoid committing the offence. To succeed with that defence, the burden of proof now shifts. The defence must show "on the balance of probability" that they did indeed take the appropriate steps. If they have in their possession a test cert showing compliance with the harmonised standard, they can reasonably presume that their product (at least when tested) complied with the Directive, that's what the presumption says, they don't have to dig further, the presumption is that the standards writers knew what they were doing. That effectively says that the design is OK, but it of course says nothing about quality control in series production. 4) Then, provided they have additional evidence of reasonable (not perfect, just reasonable) production testing and control, they probably have enough for the due diligence defence to succeed. Maybe the sample slipped through untested, maybe the test voltage was set wrong in the Far Eastern factory, who knows? As an importer, say, what else could they have reasonably done? It is not as weighted in favour of the prosecution as some seem to think. John C -----Original Message----- From: John Woodgate [mailto:[email protected]] Sent: 26 January 2011 18:44 To: [email protected] Subject: Re: [PSES] dow for new standards In message <006201cbbd86$ec58c8e0$c50a5aa0$@com>, dated Wed, 26 Jan 2011, Dennis Ward <[email protected]> writes: >It basically says, 'since you are 100% responsible, it is you that has >to prove it, not I who brings your assumptions into question." The >very fact that it is an 'assumption' of conformity shows the burden of >proof is on the one 'assuming', if and when that assumption is called >into question. Crucial wrong word. It's not 'assumption' but 'presumption', which means that the burden of proof is on whoever is challenging the PREsumption. -- OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK Plural: data, criteria, phenomena. Singular: datum (different meaning: use 'data element' for a single item), criterion, phenomenon. 'Effect' is a noun, 'affect' is a verb (except in psychiatry). - ---------------------------------------------------------------- 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://product-compliance.oc.ieee.org/ Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html 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]> - ---------------------------------------------------------------- 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://product-compliance.oc.ieee.org/ Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html 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]>
