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 |
 |
| Human Factors Collection CD | HFCOL-CD |
$195 |
$375 |
|
Interested in more guidance and examples? Handbook of Human Factors in Medical Device Design was written as a complement to HE75. This handbook includes expanded discussion of design issues, product design case studies, and supporting illustrations. While some AAMI Human Factors committee members were involved in editing this handbook, it was not developed by the AAMI committee.
Click here for more information.
To order, call AAMI’s Customer Service Center at +1 877-249-8226.