Standards only allow the presumption of conformity to the essential requirements of a directive; they do not show actual or absolute conformity; and they are not mandatory. This only means that you can test till the cows come home, but you still only have a presumption of conformity under an accepted non-mandatory method, not that any ‘legal’ or actual conformity even exists.
It should also to be understood that regardless of when or how any previous presumption of conformity was or was not made, at least for most directives of which I am aware, it is always the 100% responsibility of the manufacturer to maintain that presumption of compliance for any product they place on the market. It should also be remembered that wear and tear on the product does not alleviate the responsibility of the manufacturer that his product is to remain in conformity to the essential requirements of a directive. Presumption of conformity does not necessarily mean legal compliance to any specific law, it means that it is the ‘opinion’ of the manufacturer that, because of his due diligence in applying accepted non-mandatory standards, his product is assumed to meet the essential requirements of whatever directive applies to his product. This after all is NOT a certification process whereby the legal entities responsible approve a device for use, it is DoC whereby the manufacturer declares under his responsibility that his device is in conformity based on assumptions he has made. However, while rare when considering the total number of products on the market, there are those cases that regardless of all the assumptions made, regardless of all the ‘due diligence’ done, regardless of all the standards to which compliance is assumed and regardless of when any standard became available or lost availability to show presumption of conformity, there are those instances when failure to meet the essential requirements will happen. It may be that at that time, when brought into court, the manufacturer will have to prove and convince the legal entities that a device is safe and it meets the essential requirements, not just is presumed to meet them or has simply passed a set of non-mandatory standards. At that time, if the manufacturer can prove his product is in conformity, then there should be no problem. If however, he cannot prove conformity, then the legal ramifications go into effect. While part of the manufacturers arsenal of proof may be test results obtained during the initial presumption stage, and evidence of continued due diligence of his product during the life cycle of that product while on the market, that is not all that may be required. It may be that the legal entities would require much more in the way of proof. Dennis Ward Director of Engineering American Certification Body Certification Resource for the Wireless Industry http://www.acbcert.com 703-847-4700 fax 703-847-6888 direct - 703-880-4841 From: [email protected] [mailto:[email protected]] On Behalf Of Kim Boll Jensen Sent: Wednesday, January 26, 2011 2:50 AM To: EMC PSTC Subject: dow for new standards Hi I’m in a special situation on an LVD standard. An old product has failed in the market and the discussion is now was it or was it not legally CE marked. A new sub standard (-2-x) to a general standard (-1) was issued and from that day the product was illegal but before it was legal. But the new sub standard has never been on the list of harmonised standards before. The list has therefore no dow for the standard, but in the standard there are a dow date. My question is now: 1: Does the standard apply without a transitional period from the dop in the OJ 2: Does the dow in the standard give the end of transitional period My problem is that I need an official statement of what is right since it shall be used in court. Best regards, Kim Jensen - ---------------------------------------------------------------- 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]>

