ANSI/AAMI HE75, 2009(R)2018 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
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.
Published: March 2010, Reaffirmed August 2018, 445 pages.
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