Use specification

The use specification covers the medical indication, patient population, user profiles, use environment and operating principle. It is the starting point of usability engineering and feeds the intended use in risk management.

summary of the important characteristics related to the context of use of the MEDICAL DEVICE Note 1 to entry: The intended medical indication, PATIENT population, part of the body or type of tissue interacted with, USER PROFILE, USE ENVIRONMENT, and operating principle are typical elements of the USE SPECIFICATION. Note 2 to entry: The summary of the MEDICAL DEVICE USE SPECIFICATION is referred to by some authorities having jurisdiction as the ‘statement of intended use’. Note 3 to entry: The USE SPECIFICATION is an input to determining the INTENDED USE of ISO 14971:2019.

IEC 62366-1:2015+AMD1:2020, clause 3.23