scope:

General

This recommended practice addresses a broad range of human factors engineering (HFE) topics in a structured format. Examples are provided, as are references to more detailed information. The material emphasizes adoption of a user-centered focus throughout the product design and development process, with the goal of making medical devices easier to use and less prone to use error.

The presumed users of this document are human factors and usability specialists, software developers, industrial, biomedical, mechanical, and electrical engineers, and other development personnel. Other users might include clinicians, clinical and biomedical engineers, and others who evaluate devices before purchase or after use errors have occurred, regulatory agencies, purchasing entities, and others interested in assessing the usability of medical devices.

Inclusions

This recommended practice covers general HFE principles, specific HFE principles geared towards certain userinterface attributes, and special applications of HFE (e.g., hand tool design).

Exclusions

This recommended practice does not provide detailed recommendations on all aspects of the human factors medical device design process (see ANSI/AAMI HE74:2001/(R)2009).