Jan, There are two issues here: - 1. The standard that you refer to is harmonised under the Medical Devices Directive, not the EMC Directive, so you need to be careful about which Directive you cite in your Declaration of Conformity. 2. If your chosen route to conformity is by compliance with a harmonised standard, which should be cited in your D of C with its date, then that D of C is only valid as long as the standard is valid. Once the cited standard is withdrawn the D of C is no longer valid and the product must be assessed against the superseding standard. There may or may not be any need to retest, depending on the changes to the standard and the parts that are relevant to the product. A Competent Body review may be sufficient (or Notified Body in the case of the MDD or the forthcoming new EMCD). You may also have seen the DoW referred to as the DOCOPOCOSS or Date Of Cessation Of Presumption Of Conformity Over the Superseded Standard, which pretty much explains the situation. I hope this helps. Best regards,
Neil R. Barker C.Eng. MIEE FSEE MIEEE Manager Compliance Engineering e2v technologies (uk) ltd 106 Waterhouse Lane Chelmsford Essex CM1 2QU UK Tel: +44 (0)1245 453616 Fax: +44 (0)1245 453410 e-mail: [email protected] Web: http://www.e2v.com <http://www.e2v.com/> From: [email protected] [mailto:[email protected]] Sent: 13 April 2005 10:27 To: [email protected] Subject: question concerning EMC directive: old standard is superseded by new standard EMC-pstc-list, I have a question concerning the EMC directive. We are in a situation were an old standard EN 60601-1-2:1993 is superseded by a new one: EN 60601-1-2:2001. I have a discussion with a colleague about what should happen after the date of withdrawel (DOW). Here is a small part from a text that my colleagues are referring to): When a harmonized standard used for presumption of conformity changes (as a result of a new edition, for example), then the presumption of conformity cannot be continued ad-infinitum by the manufacturer. Until the manufacturer can demonstrate conformity to the newer version of the standard he cannot affix a CE marking to the product or place it on the EU market.. Often this is not well understood. iI fact, many manufacturers think that their product is "grandfathered". The truth is, all devices placed on the market after DOW must meet the new version of the standard if the manufacturer wishes to continue to legally affixing the CE mark. This interpretation differes from my personal view: A product should comply with the essential requirements of the EMC directive, that is, (1) protection of radio-service and (2) immunity with respect to external disturbances. One should use all (applicable) standards to demonstrate the above. If a harmonized standard changes, for example a new edition, then it is not necessary ilegal to affix the CE label and place the equipment on the EU market. We have already demonstrated that it meets the essential requirments of the EMC directive. Of course, when there is a technical change in the standard then a (risk) analysis should be done to assess the effect on the EMC performance and, possibly, action is required on behalf of the manufacturer. So all devices placed on the market after the DOW do not necessarily have to meet the new standard. And in theory it is possible that products are indeed "grandfathered" This probably an old topic. (???) Kind regards, Jan Vercammen EMC engineer ---------------------------------------------------------------- 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 [email protected] Instructions: http://listserv.ieee.org/listserv/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: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
