IEC 62366-1 specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device with respect to safety.
This usability engineering process allows the manufacturer to assess and mitigate the risks associated with correct use and handling errors, i.e. normal use.
It can be used to identify risks associated with abnormal use, but does not assess or reduce them. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition and amendment 2007 (62366) of IEC 1 published in 2014.
Chapter 1 has been updated to include contemporary concepts of usability engineering while modernizing the process.
Part 2 contains tutorials to help manufacturers comply with part 1, and also provides more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond the safety-related aspects of medical device user interfaces.
EUROLAB assists manufacturers with IEC 62366-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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