IEC 60601 3rd Edition

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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?

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