EN 62366-1: Application of usability engineering to medical devices

This regulation is also one of those that was already among the harmonized standards in the old directives.

• 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 evaluate and mitigate the risks associated with correct use and use errors, that is, normal use.
• It can be used to identify risks, but does not evaluate or mitigate the risks associated with abnormal use.
• This process is carried out in parallel to the risk management process.

A summary of the scope of this regulation is presented in the following image:

62366-1 usability

As can be seen, the scope of the usability regulation 62366-1 refers to the normal use of our medical device software.

The summary of activities to be carried out are the following:

• Usability engineering plan
• Usability input data
• Preparation specification of use
• Analysis
• Formative design and evaluation
• Summative evaluation