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Underwriters Laboratories UL

FDA Compliance

Get Quick Answers on Conformity to IEC 60601 Third Edition

Underwriters Laboratories released a downloadable document addressing more than 70 FAQ

Published: Wednesday, December 1, 2010 - 15:30

(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.

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.

“It’s critical for industry to have the tools and reference documents to help them understand the flexibility of the standard and design medical devices that advance new technologies and bring safer products to market,” says Anil Patel, UL’s general manager for the health sciences industry. “With input from our engineers who participate on the technical committees, this [FAQ] document provides quick answers to many questions that manufacturers may have for their products to meet the June 2012 transition dates set by the EU and Health Canada.”

Currently, manufacturers of active medical devices can use IEC 60601 second edition to demonstrate their product meets safety requirements. IEC 60601 second edition is globally harmonized such that most regulatory authorities currently recognize the second edition as the accepted standard to assess the safety of an active medical device. The third edition of IEC 60601 incorporates significant changes from the previous edition of IEC 60601. Some of the more significant changes allow manufacturers to utilize their risk management process to determine acceptable test limits and conditions.

The “UL’s Comprehensive 60601 3rd edition Q&A” document may be downloaded from the UL Health Sciences web page under the “additional resources” section at www.UL.com/medical.

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Underwriters Laboratories UL

Underwriters Laboratories Inc. (UL) is a global independent safety science company offering expertise across five key strategic businesses: Product Safety, Environment, Life & Health, Knowledge Services, and Verification Services. UL’s worldwide family of companies and network of service providers includes 64 laboratory, testing and certification facilities serving customers in 96 countries.