The standard details a risk management-based usability engineering process which aims to design a medical device with reasonable usability - easy to learn and use, as a way to minimize use errors and use-related risks.
Thanks for the quick reply. Now, I have been reviewing EN 60601-1-6:2004 to find the differences between EN 62366 and 60601-1-6. They seem to have the same information. IS there a difference?
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