IEC released the 3rd edition of IEC 60601-1, a major leap forward in safety and performance of electrical medical devices

Certification Organizations and manufacturers will experience significant changes as they adapt to IEC 60601-1:2005, but this process will bring about improvements in the safety and effectiveness of medical devices. Amongst other relevant changes, the enhanced role of risk management in compliance of ISO 14971 must be highlighted. Manufacturers will need to demonstrate that a risk management process is in place and that it has been applied to the device being certified, and data relevant to the compliance of IEC 60601-1 shall need to be included in the risk management file. This will also have an effect on the definition of the actual set of tests being performed.

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