Conformity Magazine - March 2008 - (Page 19)

The manufacturer, or his authorised representative in the EU, must keep this technical documentation “…at the disposal of the competent authorities for at least ten years after the date on which such apparatus was last manufactured…”. This can present logistical or security difficulties, which should be able to be overcome by appropriate use of electronic file storage and the Internet. According to Annex IV, the technical documentation must include: a. b. c. A general description of the apparatus (should cover the range of configurations); A description of the procedures used to ensure compliance with the Protection Requirements; Any reports from Notified Bodies (see Employing Notified Bodies, above). The User Instructions to be provided must include any specific precautions required to ensure compliance with the Protection Requirements (e.g., EMC instructions for assembly, location, installation, commissioning, operation, maintenance, upgrade, repair, etc.), and must also describe how to operate the apparatus to achieve its intended purpose(s). If an apparatus is not designed to meet residential/domestic emissions standards – but might be used in such environments – it must be accompanied by a clear warning that use in residential areas might cause interference. This warning may also need to be placed on the product’s packaging. The EC Declaration of Conformity Annex IV of 2004/108/EC requires the Declaration of Conformity to: a. Identify the manufacturer and give his address (“rebadgers” are manufacturers); also identify the authorised representative in the EU (if any) and give his address too; Make reference to 2004/108/EC; Identify the product(s) covered by the declaration; Include two legal statements: Documenting the procedures used to ensure EMC compliance means describing the EMC Assessment that was carried out (see The EMC Assessment Process, above) and will consist mainly of documents created during that work. If conformity relied on testing to all of the relevant harmonised EMC standards, this could simply be their test reports. But, when following the alternative route, more detailed documentation is required, for example: • Technical arguments (e.g., calculations, simulations, results of tests carried out on sub-assemblies, etc.); • Results of any EMC testing in design, manufacture, installation or operation (including non-standard methods); • Any reasonable limitations to use agreed with the customer and/or described in the user manuals (e.g., keeping cellphones and walkie-talkies well away). If using technical arguments based on EMC testing, include the following details (where appropriate): • The test set-up (including similarities and deviations from harmonised standard tests); • The instrumentation used, and its calibration state; • The rationale for choice of parameters and limits; • The calculated uncertainties. The Information to be Provided with Each Apparatus Article 9 of 2004/108/EC requires the provision of specified EMC information with each apparatus. Each apparatus must be identified (e.g., by type, batch, serial number, etc.) and accompanied by its manufacturer’s name and address. If an agent or importer in the EU is involved, their contact details must also be included. b. c. d. Standard design reduces cost for Board Level Shielding Unique spring finger between fence and cover offers the design flexibility of a removable cover without expensive tooling. Free Samples at www.tech-etch.com/shield ISO 9001:2000 REGISTERED TECH-ETCH, INC., 45 Aldrin Road, Plymouth, MA 02360 marCh 2008 Conformity 19 http://www.tech-etch.com/shield http://www.tech-etch.com/shield

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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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