Usability engineering means the development of products suitable for use and can be assigned to a subarea of ergonomics. Ergonomics deals with the optimal adaptation of work on humans. According to IEC 62366, usability is a property of the user-product interface that encompasses the effectiveness, efficiency, ease of learning and satisfaction of the user.
In the context of medicine, the safety factor in usability gains additional importance: the usability of a medical device is largely dependent on the user group and the environment of use. This means that devices must be produced in such a way that their use under intended conditions and purposes does not endanger the clinical condition and safety of patients, nor the safety and health of users or, where applicable, third parties.
Acceptable risks associated with the intended use, measured in terms of benefit to the patient, must be compatible with a high level of health protection and safety.