ANSI AAMI HE75-2009 (2018) PDF

Full title and description

ANSI/AAMI HE75:2009 (R2018) — Human factors engineering — Design of medical devices. A recommended-practice guidance that consolidates human factors and usability principles, design recommendations, examples and checklists intended to help manufacturers, designers and evaluators create safer, more usable medical devices and reduce use‑related risk throughout the product lifecycle.

Abstract

This document provides comprehensive human factors engineering (HFE) guidance for medical device design. It covers general HFE principles and specific recommendations for user interfaces and device attributes (controls, displays, connectors, alarms, software UIs, packaging, labeling and documentation), methods for identifying and mitigating use‑related risk, anthropometry and biomechanics, environmental and accessibility considerations, and formative and summative usability testing. The 2018 release is a reaffirmation/revision of the original 2009 recommended practice that incorporated clarifications and updates to examples and guidance.

General information

• Status: Superseded — this 2009/(R)2018 edition has been superseded by ANSI/AAMI HE75:2025.
• Publication date: Original: 2009; reaffirmation/revision published 10 August 2018 (ANSI/AAMI HE75:2009 (R)2018).
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI); American National Standard (ANSI) designation.
• ICS / categories: Health care technology / Medical equipment (ICS 11.040); ergonomics / human factors guidance and related healthcare safety categories.
• Edition / version: ANSI/AAMI HE75:2009 (R2018) — Recommended practice (2009 edition, reaffirmed/updated 2018).
• Number of pages: 465 pages (full recommended practice text in the 2018 reissue).

Scope

HE75:2009/(R)2018 gives device developers and evaluators practical, example‑driven human factors guidance applicable across a wide range of medical devices and contexts of use: hospitals, clinics, transportable devices, home health care and mobile devices. The scope includes establishing user‑centred design practices, applying anthropometric and biomechanical data, designing and assessing user interfaces and physical controls, managing use‑related risk, conducting usability testing, and addressing post‑market usability issues and accessibility. It is intended to support safer device design rather than define regulatory process requirements.

Key topics and requirements

• Principles of user‑centred design and integration of HFE across the product lifecycle.
• Identifying and managing risk of use error via use‑related risk analysis and design mitigations.
• Anthropometry, biomechanics and physical interaction design guidance for ergonomics and fit.
• Design guidance for displays, controls, connectors, alarms, automation and software user interfaces.
• Guidance for labeling, symbols, markings, user documentation and packaging design to support safe use.
• Usability testing methods (formative and summative), test planning, selection of representative users and realistic tasks.
• Special topics: home‑use devices, mobile devices, hand tools, workstations, post‑market monitoring and accessibility considerations.
• Practical examples, checklists and references to support implementation of HFE practices.

Typical use and users

The standard is used by human factors and usability engineers, industrial/product designers, biomedical and software engineers, regulatory and quality professionals, clinical evaluators, procurement specialists and academic students. Manufacturers refer to HE75 for design guidance, for preparing usability engineering documentation and for improving device safety and usability. Health‑care organizations and regulators may use it as a reference when assessing device design and use‑related risks.

Related standards

Commonly used together with ISO 14971 (risk management for medical devices), ANSI/AAMI/IEC 62366‑1 (application of usability engineering to medical devices), IEC 60601‑1‑6 (usability collateral standard for medical electrical equipment), AAMI technical reports and guidance documents (for example TIR57 and related HFE publications), and human factors/ergonomics standards and guidance such as ISO 9241 series.

Keywords

human factors, usability, medical device design, user‑centred design, use‑related risk, usability testing, anthropometry, labeling, alarms, software user interface, accessibility, post‑market, AAMI, ANSI HE75

FAQ

Q: What is this standard?

A: ANSI/AAMI HE75:2009 (R2018) is a recommended practice that compiles human factors engineering principles, design guidance and usability testing recommendations for medical devices to reduce use errors and improve safety and usability.

Q: What does it cover?

A: It covers user‑centred design practices, use‑related risk management, anthropometry and biomechanics, interfaces (controls, displays, connectors, alarms, software UIs), labeling and documentation, packaging, usability testing methods, home‑use and mobile device considerations, accessibility and post‑market usability issues, with examples and checklists for practical application.

Q: Who typically uses it?

A: Human factors and usability engineers, product designers, biomedical and software engineers, regulatory and quality teams, clinical evaluators, procurement specialists and students working on medical device design and evaluation.

Q: Is it current or superseded?

A: The 2009/(R)2018 edition has been superseded by a later revision (ANSI/AAMI HE75:2025). The HE75:2009 designation with the R2018 reissue refers to the 2009 recommended practice as reaffirmed/updated in 2018; organizations working to current best practice should reference the 2025 revision for the most up‑to‑date guidance while the 2009/(R)2018 text remains a useful historical reference.

Q: Is it part of a series?

A: HE75 is part of AAMI's human factors and usability work program and is commonly used in conjunction with related AAMI reports and international standards (for example AAMI/IEC 62366, IEC 60601‑1‑6 and ISO 14971) as part of a comprehensive usability‑ and risk‑based design approach.

Q: What are the key keywords?

A: Human factors, usability, medical devices, user‑centred design, use‑related risk, usability testing, anthropometry, alarms, software UI, accessibility, labeling.