This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to SAFETY of a MEDICAL DEVICE. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS. 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 International Standard has been complied with and the acceptance criteria established in the USABILITY VALIDATION plan have been met (see 29 5.7), then the RESIDUAL RISKS, as defined in ISO 14971, associated
DS/EN 62366:2008 history
2008DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices