All medical manufacturers must comply with the updated IEC 60601-1 Standard, or the 3rd Edition, establishing new requirements for the safety and effectiveness of medical equipment. The standard will take effect in June 2012 in Europe and Canada and in June 2013 in the United States. Failure to implement the requirement can result in delaying the product to market and lost revenue.
To help manufacturers learn about and plan for the new edition of the Standard, TÜV Rheinland is hosting a seminar “Transitioning to IEC 60601-1 3rd Edition.” The presenter is Dale Hallerberg, Technical Manager for Medical Product Testing at TÜV Rheinland, who was a part of the IEC 60601-1 development team. Hallerberg holds a bachelor’s of science degree in Electrical Engineering from the University of Illinois in Champaign, Ill. He has more than 25 years of experience in product safety testing and electrical safety research and is a member of the Association for the Advancement of Medical Instrumentation Electrical Section.
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