IEC 62366 “Medical devices – Application of usability engineering to medical devices” specifies a process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to safety of a medical device.
Please note that since 2015 this standard is published as a series of standards. Hence the standard is now published as IEC 62366-1. The IEC TR 62366-2 gives guidance on the application of IEC 62366-1.
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