IEC 62366-1:2015 has been published February 25th, 2015 by IEC. The new usability (human factors) standard specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety. IEC 62366-1, together with the IEC 62366-2, cancels and replaces the IEC 62366 published in 2007 and its Amendment 1 (2014). Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process. It strengthens links to ISO 14971:2007 and the related methods of risk management as applied to safety related aspects of medical device user interfaces. Part 2 contains tutorial information to assist manufactures in complying with Part 1, as well as offering more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond safety-related aspects of medical device user interfaces.

For further information, please contact Torsten.Gruchmann. Use-Lab is also offering in-house training for this topic.

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