1.1 * Scope
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify,
design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL
PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY
problems associated with CORRECT USE and USE ERRORS, i.e., NORMAL USE. It can be used to
identify but does not assess or mitigate RISKS associated with ABNORMAL USE. If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied
with and the acceptance criteria documented in the USABILITY VALIDATION plan have been met
(see 5.9 of IEC 62366:2007), then the RESIDUAL RISKS, as defined in ISO 14971, associated
with USABILITY of ME EQUIPMENT are presumed to be acceptable, unless there is OBJECTIVE
EVIDENCE to the contrary (see 4.1.2 of IEC 62366:2007).