AAMI Adopts International Standard to Replace HE74

Abstract

AAMI and the American National Standards Institute (ANSI) voted in late October 2010 to adopt the international standard IEC 62366:2007 Medical devices – Application of usability engineering to medical devices. This document replaces the existing AAMI standard HE74 Human factors design process for medical devices.IEC 62366 was developed by Joint Working Group (JWG) 4, Medical devices – General requirements for safety and essential performance - Usability, of Subcommittee (SC) 62A, Common aspects of electrical equipment used in medical practice. U.S. experts participated in its development.The international standard describes a usability engineering process and provides guidance on how to implement and execute the process to provide safety in medical devices. It is intended to be useful not only for manufacturers of medical devices, but also for technical committees responsible for the preparation of particular medical device standards.AAMI encourages its committees to harmonize their work with international standards to the extent possible. Upon review of IEC 62366:2007, the AAMI Human Factors Engineering Committee, which serves as the U.S. Technical Advisory sub-Group (sub-TAG) to JWG 4, decided to adopt it verbatim as a revision of ANSI/AAMI HE74:2001/(R)2009.To order ANSI/AAMI/IEC 62366:2007, call (877) 249-8226 or visit http://marketplace.aami.org. Order code 62366, source code PB. List price $120, AAMI member price $60.