AAMI ANSI/AAMI HE75:2025

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Human factors engineering—Design of medical devices

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AAMI ANSI/AAMI HE75:2025

The purpose of ANSI/AAMI HE75, Human factors engineering—Design of medical devices, is to provide comprehensive guidance and design principles for applying human factors engineering (HFE) to medical devices.

The ultimate goals are to:

  • Make medical devices easier to use: By adopting a user-centered focus throughout the product design and development process.
  • Reduce use error: By optimizing the user interface and overall design to minimize the potential for mistakes during operation, thereby enhancing patient safety.

In essence, AAMI HE75 serves as an encyclopedia of human factors information and design criteria that medical device manufacturers use to:

  • Understand human capabilities and limitations (e.g., in vision, hearing, physical strength).
  • Systematically identify, analyze, and mitigate use-related risks.
  • Design effective user interface attributes (e.g., connectors, controls, displays, alarms, software).
  • Align their design and documentation with regulatory expectations for human factors and usability.
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