EVS-EN 60601-1-6:2010+A1:2015

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.