IEC 62366 Test Standard for Usability Engineering for Medical Devices

IEC 62366 aims to regulate the application of usability engineering to medical devices. The standard defines a process by which a manufacturer can analyze, determine, develop and evaluate the safety-related usability of a medical device. This process helps the manufacturer analyze and reduce the risks associated with normal use of the medical device. This standard also enables the manufacturer to identify the risks associated with abnormal use of the device. However, this standard cannot analyze or mitigate such risks.

Providing a usability engineering file (UEF) for the medical device will include:

• Using medical device features in usability engineering;
• Intended medical use and intended medical indication;
• patient and user groups;
• Use the environment and functionality; this includes the physical principle and technical structure;
• Application of the medical device, ie the part of the body or type of tissue to which the device will be applied.

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