Overview

The usability engineering standard for medical devices. It specifies a process for analysing, specifying, developing and evaluating the usability of a device as it relates to safety, addressing use errors and use-related hazards. Current text is the 2015 edition with Amendment 1:2020.

IEC 62366-1:2015+AMD1:2020, Medical devices — Part 1: Application of usability engineering to medical devices, specifies the usability engineering process manufacturers apply to medical devices. The first edition of Part 1, together with the first edition of IEC 62366-2, cancelled and replaced IEC 62366:2007 and its Amendment 1:2014, updating the standard to contemporary usability engineering concepts. Amendment 1 was published in 2020, and a technical corrigendum was issued in 2016; the consolidated text is what is normally applied.

The standard's subject is usability as it relates to safety, not usability in the general sense of user satisfaction or efficiency. Its concern is that a user — clinician, carer, patient or technician — may use a device in a way that leads to harm, whether through a use error, an inadequate mental model of how the device works, or a user interface that makes the wrong action easy and the right action hard. General usability improvements are welcome but out of scope.

The process it defines runs as follows. The manufacturer prepares a use specification describing the intended medical indication, patient population, part of the body or type of tissue, user profile, use environment and operating principle. It identifies user interface characteristics related to safety and known or foreseeable hazards and hazardous situations. From these it identifies and describes hazard-related use scenarios and selects those to be included in summative evaluation. It then specifies the user interface, including the accompanying documentation and any training, performs user interface evaluation, and records the results in a usability engineering file.

Evaluation comes in two forms. Formative evaluation is conducted during development to explore design strengths and weaknesses and to inform the design; it is iterative and diagnostic. Summative evaluation is conducted at the end to obtain objective evidence that the user interface can be used safely, using representative users, realistic environments and the hazard-related use scenarios selected earlier. Findings that reveal residual use-related risk must be fed back into risk management.

The standard is tightly coupled to ISO 14971. Use-related hazardous situations identified through the usability process become inputs to the device risk management file, risk control measures affecting the user interface are evaluated for their own usability consequences, and residual use-related risk is evaluated within the overall residual risk assessment. Applying the two standards as separate exercises is the most common structural mistake in this area. IEC 62366-1 also interacts with IEC 60601-1-6 for electrical medical equipment and with IEC 62304 where the user interface is realised in software.

Supporting guidance is provided by IEC TR 62366-2:2016, a technical report giving background and practical guidance on implementing the usability engineering process. It is guidance only and contains no requirements.

IEC 62366-1 is not certifiable in its own right. Conformity is demonstrated through the usability engineering file within the device technical documentation, assessed during ISO 13485 audits, notified body conformity assessment under EU MDR and IVDR, and regulatory premarket review — the FDA's human factors expectations for medical devices align closely with the same process, though the agency maintains its own guidance.

Purpose

To specify a process for a manufacturer to analyse, specify, develop and evaluate the usability of a medical device as it relates to safety, so that risks associated with correct use and use errors can be assessed and mitigated.

Key Benefits

• Provides the internationally accepted process for managing use-related risk in medical devices
• Focuses effort on hazard-related use scenarios rather than general usability polish
• Distinguishes formative evaluation for design improvement from summative evaluation for evidence
• Feeds use-related hazardous situations directly into ISO 14971 risk management
• Expected by notified bodies under EU MDR and IVDR and aligned with FDA human factors expectations
• Covers accompanying documentation and training as part of the user interface
• Applies to physical devices, software user interfaces and combination products
• Supported by IEC TR 62366-2 guidance for practical implementation

Key Requirements

• Establish and maintain a usability engineering process and a usability engineering file
• Prepare a use specification covering indication, patient population, users, use environment and operating principle
• Identify user interface characteristics related to safety and potential use errors
• Identify known and foreseeable hazards and hazardous situations related to use
• Identify and describe hazard-related use scenarios
• Select the hazard-related use scenarios to be included in summative evaluation
• Establish the user interface specification, including accompanying documentation and training
• Establish a user interface evaluation plan covering formative and summative evaluation
• Perform the user interface design and implementation, including accompanying documentation
• Conduct formative evaluation during development and use the findings to improve the design
• Conduct summative evaluation with representative users, tasks and use environments
• Analyse evaluation results, including root causes of use errors and close calls
• Feed residual use-related risk into the ISO 14971 risk management process
• Apply the process to user interface changes and, where relevant, to user interfaces of unknown provenance

Who Needs This Standard?

Medical device and in vitro diagnostic manufacturers, developers of software as a medical device and connected health applications, combination product developers, and contract design and human factors consultancies serving the sector. It concerns human factors and usability specialists, industrial and interaction designers, systems and software engineers, technical authors producing instructions for use, and regulatory affairs and risk management teams.

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