ANSI/AAMI HE75

Classification and definition

ANSI/AAMI HE75 is titled “Human factors engineering, Design of medical devices”. The standard comes from AAMI (Association for the Advancement of Medical Instrumentation). It was developed through the AAMI consensus process by the Human Factors Engineering working group, whose members come from the medical device industry, university research centers, and health care institutions.

In its human factors guidance, the FDA describes the standard as a comprehensive reference with general principles, the handling of the risk of use errors (use error), design elements, and integrated solutions. This yields its classification as a design reference for the human factors engineering of medical devices, in contrast to a process standard. This classification is derived from the FDA description and is not the standard’s own designation.

Editions and status

For a long time, the edition ANSI/AAMI HE75:2009/(R)2018 applied. According to AAMI, the 2009 version comprised 445 pages. The British standards body BSI lists it as published on October 21, 2009 and withdrawn on November 19, 2025 (as of October 2026).

On November 18, 2025, AAMI announced the edition ANSI/AAMI HE75:2025 as the first update of its human factors standard since 2009. According to AAMI, it comprises more than 500 pages. The working group was led by Mary Beth Privitera and Molly Story. According to AAMI, every section was reviewed, updated, and checked against current sources. The scope was extended to devices for home use, integrated systems, and combination products (combination product).

The text of the standard is available only for a fee, through the AAMI store or an eSubscription offering. This page therefore reports only what AAMI, BSI, and the FDA make publicly known.

Use as a design reference

According to AAMI, the standard goes back to earlier AAMI standards, namely HE48 from the 1990s and HE74 from around 2001. According to AAMI, the first edition of HE75 (2009) introduced detailed principles, design guidelines, examples, and checklists for user-centered design across different product types and integrated human factors into the entire product life cycle. HE74 is also visible in the usability collateral standard IEC 60601-1-6: according to the text of that standard, its definition of the operator-equipment interface is adapted from HE74:2001.

For manufacturers, AAMI recommends applying the content throughout development, integrating human factors across the life cycle, writing design specifications with the users in mind, structuring usability tests in line with FDA expectations, and thereby producing more robust human factors documentation for regulatory submissions. Health care institutions are also meant to use the standard, for example to evaluate devices and to analyze errors that have occurred. According to AAMI, the standard is also meant to help regulators assess the design of medical devices.

According to AAMI, regulatory expectations have changed since 2009: the FDA has since published seven human factors-related guidances, and the usability standard IEC 62366 was fundamentally revised or supplemented three times. AAMI describes the involvement of the FDA in the development of the 2025 edition as having grown. The 2025 edition also emphasizes design as a means of preventively reducing use errors.

Content of the 2025 edition

According to the AAMI description, the 2025 edition covers several blocks of topics: design priorities such as safe use, user inputs, training, instructions for use, and the risk of use errors; also anthropometry and biomechanics (body dimensions, posture, range of motion), methods for usability tests that deliver valid and reliable data, and environmental, organizational, and structural factors that affect the product and patients. Further topics are labeling, packaging, the product life cycle, training, alarm management, and global markets. The section on accessibility (Section 16) was updated.

Related terms on this platform are posture and musculoskeletal load, labeling, and packaging usability. According to AAMI, the standard names, among others, IEC 62366-1:2015, AAMI TIR 51 (contextual inquiry), and AAMI TIR 59 (design controls) as references. According to AAMI, it is aligned with the FDA’s 2016 human factors guidance. According to AAMI, Section 9 on usability tests is regarded as a key section.

Recognition by the FDA

The FDA human factors guidance (version of August 3, 2026) lists the standard AAMI/ANSI HE75 in Appendix C among the national and international consensus standards recognized by the FDA. Alongside it are IEC 62366-1, ISO 14971, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-1-11. The table gives a short description of the main purpose of each standard but gives no year for HE75. For the current edition and the extent of recognition, the guidance refers to the database of recognized consensus standards and recommends reading the Supplemental Information Sheets there.

Whether and to what extent the FDA recognizes the 2025 edition could not be derived from the public descriptions of AAMI and the guidance and has to be checked in the FDA database. The guidance is not binding. According to the guidance, anyone who submits a declaration of conformity to a recognized standard should attach the appropriate evidence.

Distinction from IEC 62366-1 and the FDA guidance

The FDA describes IEC 62366-1 (term on the standard) as a human factors and usability engineering process for the design of medical devices that takes risk management into account. HE75, by contrast, provides the design reference in terms of content. AAMI names the process standard as a reference of the 2025 edition. The process is covered in the term usability engineering process.

• The FDA human factors guidance describes what the agency expects for a regulatory submission, such as validation testing (human factors validation testing). HE75 is not an agency requirement but a consensus standard that the guidance lists as a reference.
• IEC 60601-1-6 is the collateral standard on the usability of medical electrical equipment. The FDA names it as a bridge between IEC 60601-1 and the usability standard. While the IEC 60601 series targets electrical equipment, AAMI names medical devices and combination products in general as the scope of HE75.
• The decision which standard a manufacturer uses as a reference, and how it justifies this, is the manufacturer’s own. This is an inference from the non-binding nature of the guidance and not a statement by the FDA.

Frequently asked questions (FAQ)

Sources

• FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices (Final Guidance, February 2016, revised August 2026)
• IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
• AAMI: AAMI Updates Medical Device Design Standard for First Time Since 2009 (11/18/2025)
• AAMI: Human Factors Evolution From 2009 to 2025, Exploring the New HE75
• BSI Knowledge: ANSI/AAMI HE75:2009 (R2018), Human factors engineering, Design of medical devices (withdrawn)

Related terms

• IEC 62366-1
• FDA human factors guidance
• Human factors engineering (HFE)
• IEC 60601-1-6 (Usability Collateral Standard)
• Human factors validation testing
• Usability engineering process
• Combination Product
• Use error

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