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ANSI/AAMI HE74:2001 (R2009)

Human factors design process for medical devices

By providing a structured approach to user interface design, this document can help manufacturers develop safe and usable medical devices. This document includes an overview of the human factors engineering (HFE) discipline, a discussion of the benefits of HFE, a review of the HFE process and associated analysis and design techniques, and a discussion of implementation issues and relevant national and international standards and regulations (see annex B).The document also incorporates a listing of applicable government documents and human factors engineering literature citations (see annex E).

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Association for the Advancement of Medical Instrumentation [aami]

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