Medical Device Usability Requirements: Changes to IEC 62366

Human factors (HF) professionals, particularly in the medical device industry, are familiar with the international standard IEC 62366. It covers the “Application of usability engineering to medical devices” and as such specifies usability requirements for the development of medical devices as it relates to safety. The usability engineering process as described in the standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.