IEC 60601-1-6 (Usability Collateral Standard) is the collateral standard to the general standard IEC 60601-1. It sets out a process by which manufacturers analyze, specify, design, verify, and validate the usability of medical electrical equipment, insofar as it relates to basic safety and essential performance.
Classification and definition
IEC 60601-1-6 is titled “Medical electrical equipment, Part 1-6: General requirements for basic safety and essential performance, Collateral standard: Usability”. It is a collateral standard to the general standard IEC 60601-1 for medical electrical equipment (ME equipment). According to the foreword of the standard, collateral standards set out general safety requirements that apply to a subgroup of ME equipment or to a specific characteristic of all ME equipment that the general standard does not fully address. The foreword gives alarm systems as an example.
The standard describes a process by which the manufacturer analyzes, specifies, designs, verifies, and validates the usability of ME equipment, insofar as it relates to basic safety and essential performance. This process covers risks arising from usability problems in correct use and in use errors (use error), that is, in normal use. The process can identify risks from abnormal use, but it cannot assess or reduce them.
Edition and status
The standard is available as edition 3.2, a consolidated version of the third edition of 2010 with Amendment 1 (2013) and Amendment 2 (2020). According to the IEC webstore, this version was published on July 22, 2020, replaces the second edition, and gives 2028 as its stability date (as of October 2026). The stability date is the point up to which the responsible committee leaves the content unchanged and after which it decides on confirmation, withdrawal, revision, or amendment.
In its foreword, IEC subcommittee SC 62A recommends that the third edition not be made mandatory earlier than three years after publication for newly developed equipment and not earlier than five years after publication for equipment already in production. This is a recommendation for national implementation and not a deadline. The introduction to Amendment 2 also mentions a fourth edition that, at the time, was planned for publication after 2024.
The text of the standard itself is available only for a fee. This page therefore reports only what the IEC product page, the freely available preview, and the FDA guidance make publicly visible.
Content and structure
The table of contents in the preview shows a short standard. It consists of the scope, object and related standards, the normative references, the terms and definitions, and a section on “General requirements”. This section contains conditions for the application to ME equipment and the usability engineering process for ME equipment. Informative annexes follow, including a general guidance with rationales.
The introduction explains the need: use errors caused by poor usability of ME equipment are a growing problem, and the process is meant to achieve adequate usability in order to reduce use errors and the associated risks. It also points out that the manufacturer can control only some forms of incorrect use. It describes the relationship to risk management by means of a figure in the standard IEC 62366-1.
The standard defines the operator-equipment interface as the means by which the operator and the ME equipment communicate. According to the standard, the definition is adapted from a definition in the standard ANSI/AAMI HE74:2001. The accompanying documents are regarded as part of the ME equipment and of the operator-equipment interface. In practice, this means that the instructions for use are also part of the subject matter of the usability engineering process (instructions for use).
According to clause 1.3.2, a requirement in a particular standard takes precedence over the corresponding requirement of this collateral standard.
Interplay with IEC 62366-1 and IEC 60601-1
According to the foreword, this edition was revised to align it with the usability engineering process of the standard IEC 62366-1. The normative references in the preview name IEC 62366-1:2015 with Amendment 1:2020 and ISO 14971:2019. For supplementary information on implementing the process, the standard refers to the technical report IEC TR 62366-2; see IEC 62366-2. In its guidance, the FDA describes the collateral standard as a bridge between IEC 60601-1 and IEC 62366-1.
The introduction to Amendment 1 explains the bridging function: parts of IEC 60601-1 refer normatively to IEC 60601-1-6. A manufacturer can therefore meet these requirements with a usability engineering process that conforms to the usability standard. Amendment 1 clarifies which process elements are required for conformity with the IEC 60601 series, because the usability standard contains life cycle elements that do not fit a type test. The IEC 60601 series is limited to the type testing of ME equipment and does not cover the entire life cycle, including post-production monitoring.
How a manufacturer provides the evidence in detail, and whether it does so through the usability engineering file, cannot be established from the public sources. The text of the standard is authoritative on this point.
Classification in the EU and the US
In the EU, a harmonized standard (a European standard whose reference is published in the Official Journal of the European Union) creates a presumption of conformity. Commission Implementing Decision (EU) 2021/1182 on harmonized standards for medical devices lists, in the version of June 17, 2026, IEC 60601-1 in its European version EN 60601-1:2006, but neither the collateral standard on usability nor IEC 62366-1 (as of October 2026). It follows that applying the collateral standard does not give rise to a presumption of conformity under the MDR (Regulation (EU) 2017/745, the European Medical Device Regulation). This is an inference from the list of standards and not a statement by an authority.
In the US, the FDA human factors guidance (version of August 3, 2026) names the standard in its table of recognized consensus standards on human factors engineering. The guidance points out that the database of recognized standards contains the current edition and the extent of recognition. Before a submission, manufacturers therefore check there which edition of the standard applies to the target market and, for a declaration of conformity, attach the appropriate evidence, as the guidance recommends.
Distinction from related terms
- IEC 62366-1 applies to medical devices in general, while the collateral standard targets ME equipment and its basic safety and essential performance (term on the process standard).
- IEC 60601-1-8 covers alarm systems. The FDA classifies it as a design standard for alarm systems in ME equipment and lists it alongside the usability collateral standard.
- The FDA guidance also names ANSI/AAMI HE75 as a comprehensive design reference (ANSI/AAMI HE75).
- The overarching process is described in the term usability engineering process.
IEC 60601-1-6 is the collateral standard on usability within the IEC 60601 series for medical electrical equipment. It sets out a usability engineering process that covers risks arising from usability problems in normal use.
The current version is edition 3.2 (2010 with Amendment 1 of 2013 and Amendment 2 of 2020), with a stability date of 2028 according to the IEC webstore (as of October 2026). It was aligned with the process of IEC 62366-1 and is regarded as a bridge between IEC 60601-1 and the usability standard.
The text of the standard is available only for a fee. In the EU, the standard is not listed in Implementing Decision (EU) 2021/1182; in the US, the FDA guidance names it among the recognized consensus standards.
Frequently asked questions (FAQ)
What is a collateral standard?
A collateral standard of the IEC 60601 series sets out general safety requirements for a subgroup of medical electrical equipment or for a characteristic of all such equipment that the general standard IEC 60601-1 does not fully address. It applies together with that general standard.
Does IEC 60601-1-6 apply to all medical devices?
No. The standard relates to medical electrical equipment and its basic safety and essential performance. The usability standard IEC 62366-1, by contrast, applies to medical devices in general.
Is IEC 60601-1-6 identical to IEC 62366-1?
No. The collateral standard is a standard in its own right that, according to its foreword, was aligned with the usability engineering process of IEC 62366-1. It is limited to ME equipment and to type testing within the IEC 60601 series.
Is the standard harmonized in the EU?
Implementing Decision (EU) 2021/1182 does not list it in the version of June 17, 2026 (as of October 2026). The general standard EN 60601-1:2006 is included there. This does not give rise to a presumption of conformity merely by applying the collateral standard.
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- IEC 60601-1-6:2010+AMD1:2013+AMD2:2020, Medical electrical equipment, Part 1-6: General requirements for basic safety and essential performance, Collateral standard: Usability
- IEC 62366-1:2015+AMD1:2020, Medical devices, Part 1: Application of usability engineering to medical devices
- IEC/TR 62366-2:2016, Medical devices, Part 2: Guidance on the application of usability engineering to medical devices
- IEC 60601-1-8:2006+AMD1:2012+AMD2:2020, Medical electrical equipment, Part 1-8: General requirements for basic safety and essential performance, Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- FDA Guidance: Applying Human Factors and Usability Engineering to Medical Devices (Final Guidance, February 2016, revised August 2026)
- Commission Implementing Decision (EU) 2021/1182 on harmonised standards for medical devices, consolidated version of 06/17/2026
- IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV, freely available preview (foreword, introduction, table of contents)