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AAMI HE74:2001/(R)2009

M00011108

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AAMI HE74:2001/(R)2009 Human Factors Design Process for Medical Devices

standard by Association for the Advancement of Medical Instrumentation, 10/01/2001

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The purpose of this process-oriented standard is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design. This document describes a recommended human factors engineering process for use in fulfilling user interface design requirements in the development of medical devices and systems, including hardware, software, and documentation.