NORTHBROOK, Ill., Nov. 22, 2010 — Underwriters Laboratories (UL), a world leader in product safety testing and certification, announced the release of an extensive resource that addresses more than 70 frequently asked questions regarding IEC 60601 3rd edition, which include 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 EU and Canada have until June 2012 to demonstrate conformity to the 3rd edition. As the typical design cycle for a medical device ranges from six to eighteen months, manufacturers need to begin the process as soon as possible and consider the impact to their production cycles and distribution chain. Earlier this year, the FDA announced that it will also require conformity to the 3rd 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," said Anil Patel, UL’s General Manager for the Health Sciences Industry. "With input from our engineers who participate on the technical committees, this 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 2nd edition to demonstrate their product meets safety requirements. IEC 60601 2nd edition is globally harmonized such that most regulatory authorities currently recognize the 2nd edition as the accepted standard to assess the safety of an active medical device. The 3rd edition of IEC 60601 incorporates significant changes from the 2nd 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 "Q&A with UL – IEC 60601 3rd edition" document may be downloaded from the UL Health Sciences webpage under the "additional resources" section at www.UL.com/medical.