Re: DOC Requirement for Year CE Mark is Affixed
I would agree with your interpretation, with a caveat in regard to your use of four digits for the year. We have, in the past, been told by the MHRA (the enforcing body for the Medical Devices Directive in the UK) that we were not allowed to put the year number on DofC's because it might be confused with the notified body (NB) number for a product where the NB number is a requirement (i.e. where the manufacturer's quality system has to be assessed). This was for a two digit year number so I imagine they'd take a very dim view of the use of four digits (since this is the standard format for a notified body number). Our (unofficial) response to this was to conclude that the MHRA don't know the rules which apply to products which are not medical devices very well, and to ignore them in these cases. However, we do take care to ensure the digits are not present on DofCs for medical devices - the MDD and the directives which require the digits of the year are mutually exclusive so this is the correct approach. Nick. At 19:09 -0600 2/6/08, Monrad Monsen wrote: The Low Voltage Directive 2006/95/EC states in annex III that a declaration of conformity (DOC) must contain the following elements: ... the last two digits of the year in which the CE marking was affixed. I note that a like statement is not listed for the EMC Directive. I interpret this requirement as listing the year in which the CE mark was first affixed to this model number product. If true, then the signature date on the DOC would not be adequate because a company may make a later change to a DOC and re-issue the DOC long after the first CE mark was affixed to this product line. I looked through the DOCs of others in our industry, and I do not see this being followed anywhere. What are your interpretations of this requirement? My interpretation is that the last two digits of the year statement is merely a minimum of two digits, but it allows for using a four digit year. Most people avoid using two digit years after the year 2000 crunch, so I'd prefer to use a four digit year. You can view the low voltage directive by going to http://ec.europa.eu/enterprise/electr_equipment/lv/direct/text.htmhttp://ec.europa.eu/enterprise/electr_equipment/lv/direct/text.htm; and clicking on the language version of choice (en for English, etc.). Again, the requirement is found in annex III. Thanks. -- Monrad Monrad L. Monsen Compliance Program Manager Storage Group Sun Microsystems mailto:monrad.mon...@sun.commonrad.mon...@sun.com 303.272.9612 Office - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list.Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.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 emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald:emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: DOC Requirement for Year CE Mark is Affixed
In message p06240801c46a9cb4a264@[192.168.1.30], dated Tue, 3 Jun 2008, Nick Williams nick.willi...@conformance.co.uk writes: We have, in the past, been told by the MHRA (the enforcing body for the Medical Devices Directive in the UK) that we were not allowed to put the year number on DofC's because it might be confused with the notified body (NB) number for a product where the NB number is a requirement (i.e. where the manufacturer's quality system has to be assessed). This was for a two digit year number so I imagine they'd take a very dim view of the use of four digits (since this is the standard format for a notified body number). Our (unofficial) response to this was to conclude that the MHRA don't know the rules which apply to products which are not medical devices very well, and to ignore them in these cases. However, we do take care to ensure the digits are not present on DofCs for medical devices - the MDD and the directives which require the digits of the year are mutually exclusive so this is the correct approach. 'Mutually exclusive', so it's perhaps not surprising that the requirements for the content of DoCs differ between the MDD and the LVD. But it does seem to be illogical, like so much in EU legislation. A more fundamental question is 'What is the reason for requiring the two digits to be included?' It is also far from clear what 'first affixed' means, when you take into account engineering changes in the product, changes in the edition of the safety standard which is valid, changes in the Directive which applies... For example, products now having a DoC referring to 2006/95/EC may have had the CE mark first affixed under Directive 73/23/EEC. Is that the required date, or that on which the CE mark was 'first affixed' under 2006/95/EC? In view of all these uncertainties, I think it's not surprising that many DoCs do not include the date. -- OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk Either we are causing global warming, in which case we may be able to stop it, or natural variation is causing it, and we probably can't stop it. You choose! John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list.Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.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 emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald:emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
RE: DOC Requirement for Year CE Mark is Affixed
According to Annex III, there is no mention as to a date that the DoC is signed by the signatory. Therefore, is the the last two digits of the year in which the CE marking was affixed (for the first time) the same as the date a signatory signed a DoC, if it appears on the DoC? Best regards, Ron Wellman From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of Nick Williams Sent: Tuesday, June 03, 2008 12:20 AM To: Monrad Monsen Cc: emc-p...@ieee.org Subject: Re: DOC Requirement for Year CE Mark is Affixed I would agree with your interpretation, with a caveat in regard to your use of four digits for the year. We have, in the past, been told by the MHRA (the enforcing body for the Medical Devices Directive in the UK) that we were not allowed to put the year number on DofC's because it might be confused with the notified body (NB) number for a product where the NB number is a requirement (i.e. where the manufacturer's quality system has to be assessed). This was for a two digit year number so I imagine they'd take a very dim view of the use of four digits (since this is the standard format for a notified body number). Our (unofficial) response to this was to conclude that the MHRA don't know the rules which apply to products which are not medical devices very well, and to ignore them in these cases. However, we do take care to ensure the digits are not present on DofCs for medical devices - the MDD and the directives which require the digits of the year are mutually exclusive so this is the correct approach. Nick. At 19:09 -0600 2/6/08, Monrad Monsen wrote: The Low Voltage Directive 2006/95/EC states in annex III that a declaration of conformity (DOC) must contain the following elements: ... the last two digits of the year in which the CE marking was affixed. I note that a like statement is not listed for the EMC Directive. I interpret this requirement as listing the year in which the CE mark was first affixed to this model number product. If true, then the signature date on the DOC would not be adequate because a company may make a later change to a DOC and re-issue the DOC long after the first CE mark was affixed to this product line. I looked through the DOCs of others in our industry, and I do not see this being followed anywhere. What are your interpretations of this requirement? My interpretation is that the last two digits of the year statement is merely a minimum of two digits, but it allows for using a four digit year. Most people avoid using two digit years after the year 2000 crunch, so I'd prefer to use a four digit year. You can view the low voltage directive by going to http://ec.europa.eu/enterprise/electr_equipment/lv/direct/text.htmhttp:/ /ec.europa.eu/enterprise/electr_equipment/lv/direct/text.htm and clicking on the language version of choice (en for English, etc.). Again, the requirement is found in annex III. Thanks. -- Monrad Monrad L. Monsen Compliance Program Manager Storage Group Sun Microsystems mailto:monrad.mon...@sun.commonrad.mon...@sun.com 303.272.9612 Office - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list.Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.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 emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald:emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list.Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.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 emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald:emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
Re: DOC Requirement for Year CE Mark is Affixed
In message nbenipnmgoglomnalfjlaefbcnaa.rwell...@wellman.com, dated Tue, 3 Jun 2008, Ronald R. Wellman rwell...@wellman.com writes: According to Annex III, there is no mention as to a date that the DoC is signed by the signatory. Therefore, is the the last two digits of the year in which the CE marking was affixed (for the first time) the same as the date a signatory signed a DoC, if it appears on the DoC? No, for the reasons indicated in my follow-up to Nick's message. Apart from changes to the product's internals or the applicable standards since the mark was 'first affixed', the DoC signatory may change. -- OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk Either we are causing global warming, in which case we may be able to stop it, or natural variation is causing it, and we probably can't stop it. You choose! John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list.Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.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 emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald:emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
DOC Requirement for Year CE Mark is Affixed
The Low Voltage Directive 2006/95/EC states in annex III that a declaration of conformity (DOC) must contain the following elements: ... the last two digits of the year in which the CE marking was affixed. I note that a like statement is not listed for the EMC Directive. I interpret this requirement as listing the year in which the CE mark was first affixed to this model number product. If true, then the signature date on the DOC would not be adequate because a company may make a later change to a DOC and re-issue the DOC long after the first CE mark was affixed to this product line. I looked through the DOCs of others in our industry, and I do not see this being followed anywhere. What are your interpretations of this requirement? My interpretation is that the last two digits of the year statement is merely a minimum of two digits, but it allows for using a four digit year. Most people avoid using two digit years after the year 2000 crunch, so I'd prefer to use a four digit year. You can view the low voltage directive by going to http://ec.europa.eu/enterprise/electr_equipment/lv/direct/text.htm; http://ec.europa.eu/enterprise/electr_equipment/lv/direct/text.htm and clicking on the language version of choice (en for English, etc.). Again, the requirement is found in annex III. Thanks. -- Monrad L. Monsen Compliance Program Manager Storage Group Sun Microsystems monrad.mon...@sun.com 303.272.9612 Office - This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to emc-p...@ieee.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 emcp...@ptcnh.net Mike Cantwell mcantw...@ieee.org For policy questions, send mail to: Jim Bacher: j.bac...@ieee.org David Heald: emc-p...@daveheald.com All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
