User interface evaluation

It covers both formative evaluations during development and the summative evaluation at the end. Methods include usability tests, expert reviews, heuristic analyses and cognitive walkthroughs.

PROCESS by which the MANUFACTURER explores or assesses the USER interactions with the USER INTERFACE Note 1 to entry: A USER INTERFACE EVALUATION may consist of one or more of the following techniques, amongst others, USABILITY TESTS, expert reviews, heuristic analyses, design audits or a cognitive walk through. Note 2 to entry: USER INTERFACE EVALUATION is frequently performed iteratively throughout the design and development PROCESS (this is FORMATIVE EVALUATION). Note 3 to entry: USER INTERFACE EVALUATION is a part of the activities involved in verifying and validating the overall MEDICAL DEVICE design (this is SUMMATIVE EVALUATION).

IEC 62366-1:2015+AMD1:2020, clause 3.27