Historical
ANSI/AAMI/IEC 62366-1:2015
Medical devices - Part 1: Application of usability engineering to medical devices
Specifies a PROCESS for a MANUFACTURER to analyze, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN FACTORSENGINEERING) PROCESS permits the MANUFACTURER to assess and mitigate RISKS associated with CORRECTUSE and USE ERRORS, i.e., NORMAL USE. It can be used to identify but does not assess or mitigate RISKS associated with ABNORMAL USE. Partial revision of ANSI/AAMI/IEC 62366:2007 (R2013).
CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]
Association for the Advancement of Medical Instrumentation [aami]