Conformity Magazine - February 2009 - (Page 11)

NewsBreaks Representative, Distributor and Importer,” which provides harmonized definitions for these terms. The FDA’s notice and request for comment on the GHTF documents was published in the Federal Register, and can be viewed at www.conformity.com/ 2611. Copies of the GHTF documents can be found by going to the GHTF web site, www.ghtf.org, and by clicking on the link “Latest Guidance Documents” on the left-hand side of the page. Comments are due to the FDA by February 17, 2009. According to a press release issued by the EU Parliament, the need for a new toy safety directive is warranted because of the types of materials and technologies that are now being used to manufacture toys, and to ensure consistency with other regulations and policies adopted by the EU subsequent to the enactment of the original Toy Directive in 1988. An “explanatory memorandum” accompanying the draft directive details the main changes proposed in the revision. The changes include enhanced safety requirements regarding the use of chemicals in toys, and updated requirements on electrical properties, and in physical and mechanical areas to addressing choking and suffocation risks. The draft directive approved by Parliament’s Internal Market Committee was slated for a vote by the Parliament plenary in December. At that point, negotiations would begin between the EU Council and the EU Commission, with the aim of reaching a “firstreading” agreement as soon as possible. Our readers can view the complete text of the EU’s proposed directive on the safety of toys as approved by the EU Parliament’s Internal Market Committee at www.conformity.com/2613. The Commission has also published an updated list of standards that can be used to demonstrate conformity with the essential requirements of the R&TTE Directive (1999/5/EC). The list of CENELEC and ETSI standards was published in November in the Official Journal, and replaces all previously published lists for this directive. Our readers can view the complete list of standards for the R&TTE Directive at www.conformity.com/2615. Australia Now Requires Solar Panel Testing and Certification Manufacturers and distributors who sell photovoltaic (PV) modules in Australia must now ensure that their devices have been tested and certified for compliance with the applicable IEC standards. According to the International Electrotechnical Commission (IEC), PV modules must be tested and certified to either IEC 61215, Crystalline silicon terrestrial photovoltaic (PV) modules— Design qualification and type approval, or to IEC 61646, Thin-file terrestrial photovoltaic (PV) modules—Design qualification and type approval. Testing and certification must be conducted by a testing laboratory registered under the IECEE CB Scheme. Readers can read the IEC’s notice of the PV testing and certification requirement in Australia at www.conformity.com/ 2612. Additional Standards Published For The EU’s Medical Devices Directive The Commission of the European Union (EU) has also published a list of additional standards that can be used to demonstrate conformity with the essential requirements of its Directive 93/42/EEC concerning medical devices. The list of additional standards was published in November in the Official Journal, and can be viewed at www.conformity.com/2616. EU Commission Revises Standards List For EMC, R&TTE Directives The Commission of the European Union (EU) has published an updated list of standards that can be used to demonstrate conformity with the essential requirements of the EMC Directive (2004/108/EC). The list of CEN, CENELEC and ETSI standards was published in November in the Official Journal of the European Union, and replaces all previously published standards list for the directive. Our readers can view the complete list of standards for the EMC Directive at www.conformity.com/2614. EU Commission Publishes Additional Standards for Directives on Active Implantable, In Vitro Medical Devices The EU Commission has also published a list of additional standards that can be used to demonstrate conformity with the essential requirements of its Directive 90/38/EEC, relating to active implantable medical devices. The list of CENELEC standards was published in November in the Official Journal, and can be viewed at www.conformity.com/2617. Finally, the Commission has published a list of additional CENELEC standards that can be used to demonstrate conformity with the essential continued on page 53 february 2009 Conformity 11 EU Drafting New Directive on Toy Safety The Internal Market Committee of the European Union (EU) Parliament has adopted a draft directive on the safety of toys that may soon replace the EU’s current Toy Directive, 88/378/EEC. http://www.conformity.com/2611 http://www.conformity.com/2611 http://www.ghtf.org http://www.conformity.com/2615 http://www.conformity.com/2616 http://www.conformity.com/2613 http://www.conformity.com/2612 http://www.conformity.com/2612 http://www.conformity.com/2617 http://www.conformity.com/2614

Table of Contents Feed for the Digital Edition of Conformity Magazine - February 2009

Conformity Magazine - February 2009 Contents Editor's Note FCC Clarifies Closed Captioning Requirements for DTV Receivers Commission Cracks Down (For the Fifth Time!) On Junk Fax Marketer FDA Requests Comments on Global Harmonization Documents Australia Now Requires Solar Panel Testing and Certification EU Drafting New Directive on Toy Safety EU Commission Revises Standards List for EMC, R&TTE Directives Additional Standards Published For the EU's Medical Devices Directive EU Commission Publishes Additional Standards for Directives on Active Implantable, In Vitro Medical Devices EMC For the Functional Safety of Automobiles ESD Open Forum The ILAC Arrangement: Facilitating Trade Efficient Methodology for the EMI Analysis of Optical Transceivers Including PCBs and/or Flex Circuits The EuP Directive - Implementation, Design Requirements and Issues Chambers, Shielding, and Accessories Buyer's Guide CPSIA Lead Requirements Apply to Existing Inventory, Says CPSC CPSC Clarifies Certifcation Requirements Other CPSC Actions in the News IEC Standards Update Product Reviews 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 - February 2009

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