Conformity Magazine - March 2008 - (Page 18) confidence that if the product were fully tested to that standard – it would pass. It does not mean that it must be tested in an independent test lab. Manufacturers are free to decide on the amount and quality of EMC testing they do, and can do it themselves if they want. The Alternative Route to Conformity Manufacturers are under no obligation to apply any of the harmonised EMC test standards, or they might prefer to apply them but feel that some parts of them are: • Too onerous (too costly or time-consuming); • Not suitable for the actual EM environment(s) (often the case for vehicle mobile applications land/sea/air/space); • Unsuitable for the product (often the case with large machines, systems constructed on the user’s premises, etc., that cannot be fitted into the standard test chambers). So there is an alternative conformity route, essentially the “Technical Construction File” (TCF) route from the original EMC Directive without the need for assessment by a Competent Body. For products that are too large for a test method in a harmonised standard, in-situ (on-site) EMC testing is commonly used to provide evidence of compliance. Other methods of demonstrating conformity, that can be used singly or in combination and/or with the application of parts of harmonised standards, include: • Non-EU-harmonised EMC test methods (e.g., FCC, military, automotive, etc.); • EMC tests developed by the manufacturer; • Calculations; • Computer simulations; • Comparisons with compliant products using the same technologies and devices (but beware – technology and devices change very rapidly). Employing Notified Bodies 2004/108/EC has made the “Competent Body” scheme set up under the original EMC Directive obsolete, replacing it with a “Notified Body” scheme, who exist only to provide advice and assistance to whatever extent a manufacturer requires. Notified Bodies have no mandatory involvement at all with any aspect of EMC compliance, but following their advice is a good legal defence. Annex III of 2004/108/EC describes a procedure in which part (or all) of a Technical Documentation File (see The Technical Documentation File, below) is assessed by a Notified Body, whose report is then included with that Technical Documentation. This is essentially the same as the original TCF route, but which aspects the Notified Body reports on are entirely up to the manufacturer. Some manufacturers who are competent in EMC will be pleased with this change, because they no longer have to pay another expert to check their work. But many manufacturers will employ Notified Bodies where they once used Competent Bodies, either because they do not feel that they have sufficient expertise, or because they want the confidence of a second opinion. Testing Issues The less money spent on accurate testing, the more EMC expertise is required in design and assembly to achieve a given level of confidence in EMC compliance. EMC testing can be inaccurate, and the greatest confidence is achieved using labs that have been “accredited” by their national accreditation bodies for each of the EMC test standards required. Some test labs also put themselves through additional assessments by international experts who set the benchmarks in world-class EMC testing. The Technical Documentation File 2004/108/EC mandates the creation of “technical documentation,” generally referred to as a Technical Documentation File. This change brings the new EMC Directive into line with other EU directives. Comprehensive EMI Solutions, On Time & On Budget From design, quick-turn protos, and worldwide ISO9001 manufacturing, we are the superlative EMI solutions provider. The cornerstones of our mission are simple: Quality. Integrity. Service. Value. It is this commitment to total solutions without compromise that has led to our established position as a premier designer, manufacturer & distributor of EMI filters and magnetic products. Plug into our comprehensive solutions. Radius Power is a leader in the design & manufacture of power products used to condition, regulate and govern electronic performance. The company provides a broad line of EMI Filters, Power Entry Modules, Power Transformers & Inductors to meet front-end requirements for AC & DC power line applications. We offer free pre-compliance testing for conducted emissions at our labs or yours! Bring us your EMI challenge & we will provide an optimized solution usually within 48 hours. Call Radius today. 714-289-0055 PH 714-289-2149 FAX 1751 N. BATAVIA ST. ORANGE, CA 92865 www.radiuspower.com 18 Conformity marCh 2008 http://www.radiuspower.com http://www.radiuspower.com
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 Conformity Magazine - March 2008 - Conformity Magazine - March 2008 (Page Cover1) Conformity Magazine - March 2008 - Conformity Magazine - March 2008 (Page Cover2) Conformity Magazine - March 2008 - Conformity Magazine - March 2008 (Page 3) Conformity Magazine - March 2008 - NewsBreaks (Page 4) Conformity Magazine - March 2008 - NewsBreaks (Page 5) Conformity Magazine - March 2008 - Editor's Note (Page 6) Conformity Magazine - March 2008 - Editor's Note (Page 7) Conformity Magazine - March 2008 - Editor's Note (Page 8) Conformity Magazine - March 2008 - Editor's Note (Page 9) Conformity Magazine - March 2008 - FDA Gives Its Scientific Capabilities Poor Marks (Page 10) Conformity Magazine - March 2008 - FDA Warns of Patient Risk From Electric Dental Handpieces (Page 11) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 12) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 13) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 14) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 15) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 16) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 17) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 18) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 19) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 20) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 21) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 22) Conformity Magazine - March 2008 - Complying with the EMC Directive, Second Edition (Page 23) Conformity Magazine - March 2008 - ESD Open Forum (Page 24) Conformity Magazine - March 2008 - ESD Open Forum (Page 25) Conformity Magazine - March 2008 - Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All (Page 26) Conformity Magazine - March 2008 - Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All (Page 27) Conformity Magazine - March 2008 - Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All (Page 28) Conformity Magazine - March 2008 - Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All (Page 29) Conformity Magazine - March 2008 - Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All (Page 30) Conformity Magazine - March 2008 - Emerging Issues in Standards - Korean "RoHS": Not Like RoHS at All (Page 31) Conformity Magazine - March 2008 - The iNARTE Informer (Page 32) Conformity Magazine - March 2008 - The iNARTE Informer (Page 33) Conformity Magazine - March 2008 - Challenges in Testing - Field-Induced Charged Device Model: What Really Happens (Page 34) Conformity Magazine - March 2008 - Challenges in Testing - Field-Induced Charged Device Model: What Really Happens (Page 35) Conformity Magazine - March 2008 - Challenges in Testing - Field-Induced Charged Device Model: What Really Happens (Page 36) Conformity Magazine - March 2008 - Challenges in Testing - Field-Induced Charged Device Model: What Really Happens (Page 37) Conformity Magazine - March 2008 - Challenges in Testing - Field-Induced Charged Device Model: What Really Happens (Page 38) Conformity Magazine - March 2008 - Challenges in Testing - Field-Induced Charged Device Model: What Really Happens (Page 39) Conformity Magazine - March 2008 - Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment (Page 40) Conformity Magazine - March 2008 - Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment (Page 41) Conformity Magazine - March 2008 - Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment (Page 42) Conformity Magazine - March 2008 - Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment (Page 43) Conformity Magazine - March 2008 - Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment (Page 44) Conformity Magazine - March 2008 - Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment (Page 45) Conformity Magazine - March 2008 - Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment (Page 46) Conformity Magazine - March 2008 - Design Fundamentals - EMI Shielding Technologies for Consumer Electronics Equipment (Page 47) Conformity Magazine - March 2008 - Focus On...Compliance Software (Page 48) Conformity Magazine - March 2008 - Focus On...Compliance Software (Page 49) Conformity Magazine - March 2008 - Focus On...Compliance Software (Page 50) Conformity Magazine - March 2008 - Focus On...Compliance Software (Page 51) Conformity Magazine - March 2008 - Focus On...Compliance Software (Page 52) Conformity Magazine - March 2008 - Focus On...Compliance Software (Page 53) Conformity Magazine - March 2008 - Focus On...Compliance Software (Page 54) Conformity Magazine - March 2008 - Buyer's Guide (Page 55) Conformity Magazine - March 2008 - CPSC Actions in News (Page 56) Conformity Magazine - March 2008 - IEC Standards Update (Page 57) Conformity Magazine - March 2008 - IEC Standards Update (Page 58) Conformity Magazine - March 2008 - Product Reviews (Page 59) Conformity Magazine - March 2008 - Looking Back: Items from Past Issues of Conformity (Page 60) Conformity Magazine - March 2008 - Looking Back: Items from Past Issues of Conformity (Page 61) Conformity Magazine - March 2008 - Advertisers (Page 62) Conformity Magazine - March 2008 - Advertisers (Page Cover3) Conformity Magazine - March 2008 - Advertisers (Page Cover4)
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