Newletter January 2012

IEC 60601 3rd Edition

LNE/G-MED, as a leader among Notified Bodies, fielded questions from electro-medical device manufacturers on implementing IEC 60601 3rd edition since its drafting.  While the technical changes are relatively clear, until recently major questions surrounded the regulatory impact and associated documentation requirements and their impact on manufacturers.  As a result of the required changes, electro-medical device manufacturers have asked us many questions on implementing the 3rd edition to keep their devices on the market.  Using these questions, LNE/G-MED wrote a Guide for implementing IEC 60601 3rd edition for electro-medical device manufacturers in an easy-to-use question and answer format.  The Guide outlines the major principles of the IEC 60601 3rd edition series of standards and points out some major factors manufacturers can use for success with the 3rd edition.  Additionally, LNE/G-MED provides solid answers to the most important questions, lighting the way through the 3rd edition for manufacturers. Some of the questions LNE/G-MED answers include:

• What is the expiration date for the 2nd edition’s presumption of conformity for an active medical device covered under Directive 93/42/EEC?
• When should I apply a new harmonized standard, which doesn’t exist in the 2nd edition format, but which appears in the list of the harmonized standards published in the OJEU?
• What do Notified Bodies expect for products that follow the 2nd edition but are put on the market after the 2nd edition expires?
• What is expected for the medical devices already on the market before the 2nd edition expires?

Read our answers to these questions and more!  

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