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Get Quick Answers on Conformity to IEC 60601 Third Edition

Underwriters Laboratories released a downloadable document addressing more than 70 FAQ

Underwriters Laboratories UL
Wed, 12/01/2010 - 14:30
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(UL: Northbrook, IL) --  Underwriters Laboratories (UL), a world provider of product safety testing and certification, has released an extensive resource, “UL’s Comprehensive 60601 3rd edition Q&A” that addresses more than 70 frequently asked questions (FAQ) regarding IEC 60601 third edition, which includes the latest revisions to the internationally harmonized safety standard for electro-medical equipment.

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The FAQ document now available was designed to help industry address impending 2012 European and Canadian deadlines. Manufacturers selling medical devices in the European Union (EU) and Canada have until June 2012 to demonstrate conformity to the third edition of the standard.

As the typical design cycle for a medical device ranges from six to 18 months, manufacturers need to begin the process as soon as possible and consider the effect to their production cycles and distribution chain. Earlier this year, the U.S. Food and Drug Admnistration announced that it will also require conformity to the third edition by July 2013 for products sold in the United States.

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