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

 Most recent

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]


ANSI Logo

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.

CUSTOMER SERVICE
NEW YORK OFFICE
ANSI HEADQUARTERS