Primary operating function

IEC 62366-1 now focuses on hazard-related use scenarios, but primary operating functions remain a useful way to find the user interactions that matter most for safety. Loss of essential performance through use error is part of this idea.

function that involves USER interaction that is related to the SAFETY of the MEDICAL DEVICE Note 1 to entry: Often a PRIMARY OPERATING FUNCTION is interacted with by a series of TASKS that can be broken down into a series of USER interactions. Note 2 to entry: The concept of SAFETY includes loss or degradation of performance resulting in an unacceptable RISK to the PATIENT, including USE ERROR that prevents the USER from effectively using the MEDICAL DEVICE to achieve its intended medical purpose. In IEC 60601-1, this is referred to as ‘essential performance’.

IEC 62366-1:2015+AMD1:2020, clause 3.11