Customer Service:
Mon - Fri: 8:30 am - 6 pm EST


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]

Others Also Bought

Standard Practice for Performance Testing of Shipping Containers and Systems
Medical device software - Software life cycle processes - Amendment only
Medical device software - Software life cycle processes
Included in Packages
This standard is not included in any packages.
Amendments & Corrections

As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.