Conformity Magazine - March 2008 - (Page 14)

Overview of the Changes in the 2nd Edition Here is a summary list of the changes that have been made to 2nd Edition of the EMC Directive: • Some changes to the Protection Requirements; • Small changes to the EC Declaration of Conformity; • CE marking applied to products and their accompanying documents; • New requirements for manufacturers to create EMC Technical Documentation, and to ensure products are manufactured in accordance with it; • New requirements to provide specified EMC information with products; • The Technical Construction File (TCF) route under the original EMC Directive (89/336/EEC) can now effectively be used without the need for a Competent Body assessment; • Competent Bodies have been made obsolete, and replaced by “Notified Bodies” who have no mandatory involvement; • There are new requirements for the compliance of “fixed installations,” and for custom equipment. Applying 2004/108/EC 2004/108/EC applies to individual items of equipment when they are “placed on the market” or “put into service” in the EU for the first time. Its definition of equipment includes both “apparatus” and “fixed installations,” with special legal meanings for these terms. As Figure 1 shows, the new EMC Directive treats fixed installations differently from apparatus, and also has a special regime for “apparatus intended for incorporation into a given fixed installation, and not otherwise commercially available” – what might be called customdesigned or bespoke equipment. “Placed on the market” in the EU means [5]: the first time an item is offered for supply to end-users in the EU, and includes: selling, leasing and gifting. It is essentially the point where the end-user becomes the owner, however that occurs. It also means offering to sell, lease, gift, etc. (for example, by advertising, exhibiting, or making available via distributors, etc.) Non-compliant products may be advertised or exhibited if they are clearly marked as being non-compliant and not available to end-users. “Put into service” in the EU means: the first time an item is used for the purpose for which it was intended, and is mostly relevant for equipment that is assembled on the user’s site. Figure 1: Applying the 2nd Edition EMC Directive 1 Conformity marCh 2008

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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