IEC 62366

IEC 62366 is an international standard titled "Medical devices – Part 1: Application of usability engineering to medical devices." (Historically, it was titled "Medical devices – Application of usability engineering"). The standard specifies a process for a manufacturer to analyze, specify, design, implement, and evaluate the usability of a medical device, thereby minimizing use errors and associated risks. It is applicable throughout the entire lifecycle of a medical device, from initial concept to final decommissioning. The goal is to ensure that the device is safe, effective, and efficient for its intended users and use environments.

The standard emphasizes a user-centered design approach, requiring manufacturers to identify potential use errors and implement mitigation strategies. This includes understanding the intended users, the tasks they will perform with the device, and the environment in which the device will be used. Risk analysis plays a crucial role, with manufacturers needing to identify and assess the potential hazards associated with use errors.

IEC 62366 is often used in conjunction with other standards and regulations, such as ISO 14971 (Application of risk management to medical devices), to demonstrate compliance with regulatory requirements for medical devices in many countries. Adherence to IEC 62366 is often required for obtaining market access in regions such as Europe and the United States.

The standard is divided into several key sections, including:

• General requirements: These define the overall scope and application of the standard.
• Usability engineering process: This outlines the steps involved in the usability engineering process, including planning, analysis, design, implementation, and evaluation.
• Use error analysis: This specifies how to identify and analyze potential use errors.
• Usability verification and validation: This describes how to verify that the device meets usability requirements and validate that it is safe and effective for its intended use.
• Documentation: This outlines the documentation requirements for demonstrating compliance with the standard.

Regular updates and revisions to IEC 62366 are made to reflect evolving best practices and technological advancements in the field of medical device usability.