IEC 62366-1 specifies a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety.
Medical practice is increasingly using medical devices for the observation and treatment of patients. Use errors caused by inadequate medical device usability have become an increasing cause for concern. As healthcare evolves, less skilled users including patients themselves are now using more difficult devices.
Many of the medical devices developed without applying a usability engineering (human factors engineering) process are non-intuitive, difficult to learn and difficult to use. The usability engineering process is intended to identify and minimise user errors and thereby reduce risks.
IEC 62366-1 describes a usability engineering process to provide acceptable risk related to the usability of a medical device. It is intended to be useful for manufacturers of medical devices. IEC 62366-1 strictly focuses on applying usability engineering processes to optimize medical device usability as it relates to safety.
The text of IEC 62366-1:2015 has been approved in Europe as EN 62366-1:2015 without any modification.