Conformity Magazine - April 2008 - (Page 17)

compliance benchmark; therefore more than one EN standard may be necessary for complex equipment. A Notified Body must be involved in the evaluation for all Category 1 equipment and Category 2 electrical equipment. The Notified Body will issue an EC Type Examination Certificate when a product for series production complies with the test and assessment requirements of Annex III. This Certificate is evidence that the design complies with the applicable technical requirements, and applies to any equipment manufactured under one of an appropriate Quality Assurance Notification (or production licence). For bespoke (i.e., customized) equipment, the Notified Body may issue a certificate under Annex IX specific to the sample that they inspected. This certificate is called a Unit Verification Certificate and may be used for all categories of equipment. Where the evaluation process is standards-based, it follows a route that will be familiar to manufacturers of hazloc equipment. However, the EN/IEC standards do contain sufficient differences in requirements to U.S. national standards, such as UL 913 and UL 1604, that difficulties may be encountered if the equipment has not been designed with the EN/IEC standard in mind. As part of the evaluation process the manufacturer should compile a technical documentation file as described in Annex III, VIII or IX. In general, this file contains: • A general type-description; • Design and manufacturing drawings and layouts of components, subassemblies, circuits, etc; • Descriptions and explanations necessary for the understanding of said drawings and layouts and the operation of the product; • A list of the harmonized standards, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the directive where harmonized standards have not been applied; • Results of design calculations made, examinations carried out, etc; • Test reports. Establishing Effective ATEX Production Control The production control (or factory inspection) stage ensures continued conformity. A Notified Body must be involved in this stage for all Category 1 and Category 2 equipment. Electrical (gas) EN60079-0:2006* (IEC60079-0:2004) – General requirements for gases EN60079-1:2004 (IEC60079-1:2003) – Flameproof equipment for (Ex d) EN60079-11:2007 (IEC60079-11:2006) – Intrinsic safety (Ex i) Electrical (dust) EN61241-0:2006* (IEC61241-0:2004) – General requirements for dust EN61241-1:2004 (IEC61241-1:2004) – Protection by enclosures for dust (tD) EN61241-11:2006 (IEC61241-11:2006) – Protection by intrinsic safety (iD) Mechanical (gas and dust) EN13463-1:2001 – General requirements EN13463-5:2003 – Protection by construction (c) EN13463-8:2003 – Protection by liquid immersion (k) * Likely to be combined into a new EN60079-0 during 2008 Table 3: Examples of current ATEX standards April 2008 Conformity 17 http://www.haefelyemc.com http://emcsales@hipotronics.com

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Conformity Magazine - April 2008 NewsBreaks Editor’s Note Mandatory Analog Cellular Service Ends FCC Releases Quarterly Reports on Consumer Inquiries and Complaints New Standards List Released for The EU’s Low Voltage Directive FDA Issues Notification on Unretrieved Device Fragments FDA Offers Guidance on Waivers for In-Vitro Diagnostic Devices ESD Open Forum Emerging Issues in Standards Challenges in Testing Design Fundamentals Focus on... New Products Product Reviews Premarket Approval Application Guidance Issued by FDA New Jersey Enacts Electronic Waste Recycling Regulations A New U.S. Standard for Workstation and Computer Design Might the CPSC Hold Retailers Accountable for Safe Products? CPSC Loses “Sole Toy Tester” CPSC Actions in the News IEC Standards Update UL Standards Update Telcordia Standards Update From Our “You Can’t Make This Stuff Up” Department Looking Back: Items from Past Issues of Conformity Advertisers

Conformity Magazine - April 2008

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