ANSI AAMI HE75-2025 PDF

Full title and description

ANSI/AAMI HE75:2025 — Human factors engineering — Design of medical devices. A comprehensive American National Standard providing guidance, principles, examples and best practices for applying human factors and usability engineering across the medical device lifecycle to reduce use-related risk and improve safety, accessibility and effectiveness of device-user interactions.

Abstract

ANSI/AAMI HE75:2025 updates and expands the original HE75 guidance to reflect advances in human factors science, regulatory expectations and device technology since the 2009 edition. The document covers general HFE principles, device- and interface-specific guidance, anthropometry and biomechanics, realistic usability testing methods, documentation and labelling, accessibility, alarm management, packaging, post-market considerations and special guidance for home-use, software-driven and combination products. It is intended as a practical reference for embedding user-centered design and validated usability evidence into medical device development and risk management activities.

General information

• Status: Current — American National Standard (revises ANSI/AAMI HE75:2009 (R2018)).
• Publication date: April 30, 2025.
• Publisher: Association for the Advancement of Medical Instrumentation (AAMI).
• ICS / categories: 11.040 — Medical equipment; 13.340 — Ergonomics (human factors).
• Edition / version: ANSI/AAMI HE75:2025.
• Number of pages: 524 pages (approximately; full standard PDF/hardcopy).

Scope

HE75:2025 provides guidance on the application of human factors engineering to the design, evaluation and lifecycle management of medical devices and combination products. It addresses identification and control of use-related hazards, integration of HFE into design and risk management processes, selection of representative users and use scenarios, anthropometric and biomechanical considerations, user-interface attributes (hardware and software), labelling and instructions for use, packaging and environmental influences, and methods for planning and conducting valid usability tests and post-market investigations. The standard is intended for use across device classes and settings (hospital, clinic, home and field environments).

Key topics and requirements

• Human-centered design principles and integration of HFE across the product lifecycle.
• Managing the risk of use error — linking use-related hazards to design controls and mitigations.
• Requirements for user and task analysis, context-of-use definition and selection of representative users.
• Anthropometry, biomechanics and physical accessibility considerations for diverse user populations.
• Usability evaluation planning and execution: realistic scenarios, performance metrics, formative and summative testing.
• Guidance on displays, controls, connectors, alarms and software user interfaces.
• Instructions for use (IFU), labelling, symbols and documentation best practices.
• Packaging design, human factors for sterilization and handling, and post-market surveillance of use issues.
• Accessibility, cognitive considerations, training needs and alarm management strategies.
• Recommendations for evidence generation to support regulatory submissions and usability dossiers.

Typical use and users

Primary users include human factors and usability engineers, medical device designers (mechanical, electrical and software), risk managers, regulatory affairs professionals, clinical researchers and quality engineers. HE75 is used by device manufacturers to inform design requirements, plan and document usability testing and prepare human factors dossiers for regulatory submissions; by healthcare facilities and clinical engineers for device evaluation and procurement; and by academics and students as a reference for teaching HFE practices in medical device design.

Related standards

Commonly referenced and complementary standards and guidance include ANSI/AAMI/IEC 62366-1 (usability engineering for medical devices), ISO 14971 (risk management for medical devices), ISO 10993 series (biocompatibility, as applicable), and various AAMI TIRs and technical reports addressing contextual inquiry, design controls and device-specific HFE topics. HE75 is often used together with IEC/ISO usability and risk-management standards when developing usability validation evidence for regulatory bodies.

Keywords

human factors; usability engineering; medical device design; use-related risk; user-centered design; anthropometry; usability testing; instructions for use; accessibility; alarm management; labeling; IEC 62366; ISO 14971; AAMI.

FAQ

Q: What is this standard?

A: ANSI/AAMI HE75:2025 is an American National Standard that provides comprehensive guidance on applying human factors and usability engineering to medical device design with the goal of reducing use-related errors and improving safety and usability.

Q: What does it cover?

A: It covers HFE principles, user and task analyses, anthropometry and accessibility, interface and control design (hardware and software), realistic usability testing methods, labelling/IFUs, packaging, post-market considerations and how to link HFE work to risk management and regulatory evidence.

Q: Who typically uses it?

A: Human factors/usability engineers, device designers (software, hardware, mechanical), risk managers, regulatory and quality professionals, clinical engineers, procurement evaluators and educators in human factors and medical device design.

Q: Is it current or superseded?

A: HE75:2025 is the current edition (published 2025) and supersedes the prior ANSI/AAMI HE75:2009 (R2018) edition.

Q: Is it part of a series?

A: HE75 is part of AAMI’s body of standards and guidance addressing medical device safety and usability and is frequently used alongside IEC/ISO usability and risk standards (for example IEC/ISO 62366-1 and ISO 14971) and various AAMI technical reports.

Q: What are the key keywords?

A: Human factors, usability engineering, medical devices, user-centered design, use-related risk, usability testing, anthropometry, accessibility, labelling, IEC 62366, ISO 14971.