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ANSI/AAMI HE75, 2009 Edition
Human factors engineering—Design of medical devices

A virtual encyclopedia, Human factors engineering—Design of medical devices provides comprehensive guidance to device manufacturers, clinical engineers, biomedical equipment technicians, regulators, and students. This 445 page document is filled with illustrations, making the content practical and relevant to all readers.

The standard covers a significant number of specific human factors topics including:

• General principles such as design priorities, accommodating user characteristics, capabilities, needs and preferences, and compatible designs.
• Managing the risk of use error including specific methods for managing risk, use-related hazards, estimation and prioritization of use-related hazards, and implementation of risk control.
• Usability testing, user documentation, basic human skills and abilities, and environmental considerations.
• Packaging design, design for post-market issues, cross-cultural issues, alarm design, accessibility considerations, connectors and connections, and controls.
• Visual displays, software-use interface, hand tool design, workstations, mobile medical devices, and home healthcare

Click here to view the Table of Contents (pdf).

HE75 builds off many decades of basic and applied research, as well as practical experience, which generated a substantial base of scientific knowledge about people and their interactions with each other, with technology, and with their environment.

The document complements ANSI/AAMI/IEC 62366: 2007, Medical devices – Application of usability engineering to medical devices and is a revision of AAMI HE48:1993.

AAMI is making Chapter 16 - Accessibility considerations available to aid in the work of the U.S. Access Board. For more information and to download this chapter, click here.

Order Info:	Order Code	Member Price	List Price	Buy Now
ANSI/AAMI HE75:2009	HE75 or HE75-CD	$140	$280
HE75 & 62366 Human Factors Set	HESET or HESET-CD	$165	$330

To order, call AAMI’s Customer Service Center at 877-249-8226.