Conformity Magazine - March 2008 - (Page 20)

• Legal statement 1 concerns conformity to the Protection Requirements, for example: “I declare under my sole authority that the relevant equipment complies with the Protection Requirements of the EMC Directive 2004/108/EC.” • Legal statement 2 requires a list of dated references to any EMC standards (whether listed under 2004/108/ EC or not) that were applied in full or in part (and which parts) during the conformity assessment (see 2.2). e. Clearly identify, and be signed by, the Technical VicePresident (or anyone else in authority who is “legally empowered to bind the company”); Give the date of its creation. (e.g., the product is too small), it should be affixed to the packaging (if any). The CE mark must also be applied to any accompanying documents, which is a change from the original EMC Directive. The drawing of the CE marking in the original EMC Directive was modified by Directive 93/68/EEC, and 2004/108/EC uses the later version, which is shown in Figure 2 with some additional details added to make it easier to follow. Maintaining Compliance in Serial Manufacture Each individual item of apparatus manufactured must conform to its Technical Documentation File and comply with 2004/108/EC on the day it is supplied for distribution or to an end-user. So products in serial manufacture require appropriate quality control (QC) procedures that control, for example: • Changes in the EMC standards listed on their EC Declarations of Conformity; • Changes in their intended EM environment(s); • Replacement of obsolete components, component tolerances, IC die-shrinks, variations in processes and assembly/installation methods, etc.; • Design changes (to hardware, software, firmware). Appropriate QC procedures include the assessment of all proposed concessions, modifications or changes for any possible EMC effects, and sample based EMC checks and/or tests in serial manufacture. I recommend that the Technical Documentation File references the relevant QC documents, and that the results of the QC activities be added on a continuing basis. Apparatus Constructed for “Own Use” According to the EC Guide, if a manufacturer makes an item of equipment for use in their own business, then it is classified as “apparatus” and all of the requirements of 2004/108 apply – depending on whether the manufacturer chooses to classify it as “equipment intended for a fixed installation and not otherwise commercially available,” or not. People create all sorts of fixed installations for themselves, for example, domestic multimedia installations. But if they are not doing it professionally, and if they only use apparatus that is compliant with the EMC Directive and intended by their manufacturers for the use they put it to, and follow the manufacturers” EMC instructions, then no further EMC conformity assessment is required. Conformity of “Fixed Installations” f. I also recommend adding a statement concerning the availability of the Technical Documentation File and the User Instructions, and their reference numbers, to help ensure that managers leave sufficient time in the project plan for this essential legal compliance documentation to be created. The Directive states: “The manufacturer or his authorised representative in the Community shall hold the EC declaration of conformity at the disposal of the competent authorities for a period of at least ten years after the date on which such apparatus was last manufactured.” It is important to understand that it is the sole responsibility of the manufacturer to assess his apparatus and declare its conformity. A Notified Body or EMC test laboratory cannot do it. Affixing the CE Marking The CE marking (Article 8 and Annex V) must be affixed to the apparatus or its data plate. Where this is impractical Figure 2: The rules for drawing the CE Mark 20 Conformity marCh 2008 A “fixed installation” is defined as “a particular combination of several types of apparatus and, where

Table of Contents Feed for the Digital Edition of Conformity Magazine - March 2008

Conformity Magazine - March 2008 NewsBreaks Editor's Note Adelstein Renominated to the FCC Industry Canada Publishes FAQs On RF Fields FDA Gives Its Scientific Capabilities Poor Marks FDA Offers Guidance On its Product Review Process FDA Publishes Updates to List of Recognized Standards FDA Warns of Patient Risk From Electric Dental Handpieces Complying with the EMC Directive, Second Edition ESD Open Forum Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All The iNARTE Informer Challenges in Testing - Field-Induced Charged Device Model: What Really Happens Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment Focus On...Compliance Software Buyer's Guide Additional Standards Published for the EU's ATEX Directive Additional Standards for the EU's Medical Devices Directive Also Published China to Require Bar Codes to Enhance Product Safety CPSC Releases 2007 Self-Assessment CPSC Actions in News IEC Standards Update UL Standards Update Product Reviews Telcordia Standards Update From Our "You Can't Make This Stuff Up" Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - March 2008

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