Medical Device Human Factors Standards: Finding Them and What They Contain

Abstract

An HFES Task Force is considering if, when, which, and how HFES research publications should require the citation of relevant standards, policies, and practices. To support Task Force activities, papers are being written about how to find relevant standards produced by various development organizations (such as ISO, IEC and AAMI) and the content of those standards. This paper describes ISO’s, IEC’s, and AAMI’s standards programs and their technical committees and working groups that produce standards, recommended practices, technical specifications, technical information reports, guides and other publications for medical devices. This paper focuses on those medical device publications that are relevant to human factors engineering practice and explains where and how to find them.