Medica 2011: TÜV SÜD makes IEC 60601-1:2005 central theme

Medica 2011: TÜV SÜD makes IEC 60601-1:2005 central theme

TÜV SÜD will make the 3rd edition of the IEC 60601-1:2005 standard the central theme of its presence at Medica, the international medical trade fair held in Duesseldorf from 16 to 19 November 2011. The transitional period for the "Medical electrical equipment – part 1: General requirements for basic safety and essential performance" standard will expire on 1 June 2012. At Medica, Stand B05, Hall 10, TÜV SÜD provides comprehensive information about the criteria that manufacturers must fulfil to be certain of gaining market access.

Which contents of the IEC 60601-1:2005, 3rd edition, are important for the manufacturers of medical electrical devices and their components? What are the key changes compared to the old version? How to implement the new requirements into the production process in time? The medical devices professionals of TÜV SÜD provide visitors to Medica 2011 with answers to these questions. Supplying testing and certification services within the scope of the European Medical Devices Directive (MDD 93/42/EEC) for CE marking, within the scope of the NRTL procedure for the US market and the CB procedure, TÜV SÜD Product Service supports manufacturers in accessing markets worldwide. Thanks to their activities in the corresponding standards committees, the experts can also provide insights into the amendments currently under discussion for the 3rd edition of IEC 60601-1:2005. In addition, TÜV SÜD Akademie offers foundation and continuation courses on the IEC 60601-1:2005 standards targeted at medical professionals. These seminars form part of the modular training scheme to become a "Safety Expert Active Medical Devices – TÜV".

Another central theme at TÜV SÜD's stand (B05, Hall 10) at the Medica spans advanced therapy medicinal products (ATMP), from gene therapies to somatic cell therapies and tissue-engineered products. The production of ATMPs and "combined advanced therapy medicinal products" comprising constituent parts of medical devices has been clearly set forth in Regulation (EC) No. 1394/2007 since January 2009. However, the handling of ATMPs in daily practice is still the subject of intense debate. At Medica 2011, TÜV SÜD also offers a platform for exchanging ideas and information on this subject.

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