Hazard-related use scenario

These scenarios are the link between usability engineering and risk management. The summative evaluation focuses on them, so selecting them carefully decides what the validation actually proves.

USE SCENARIO that could lead to a HAZARDOUS SITUATION or HARM Note 1 to entry: A HAZARD-RELATED USE SCENARIO can often be linked to a potential USE ERROR. Note 2 to entry: A HAZARD-RELATED USE SCENARIO is not related to a failure of the MEDICAL DEVICE, unless the MEDICAL DEVICE failure was caused by a USE ERROR.

IEC 62366-1:2015+AMD1:2020, clause 3.8