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What is the IEC TR 62366-2?

Author: Marvin Kolb

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Jul 2023

What exactly is the IEC TR 62366-2? That is the basic question of this article. We have prepared all the contents for you in a compact and easy-to-understand way. When you have read this article, you will know the answers to the following questions:

  • What is the IEC TR 62366-2?
  • For whom is IEC TR 62366-2 relevant?
  • What are the contents?
  • Which version is the most recent?
  • How does the IEC TR 62366-2 relate to IEC 62366-1?

 

What is the IEC TR 62366-2?

IEC TR 62366-2 is a Technical Report prepared and issued by the International Electrotechnical Commission (IEC). It is a part of the two-part standard IEC 62366, which relates to the application of usability engineering to medical devices.

The German title is: Medizinprodukte – Teil 2: Leitlinien für die menschenzentrierte Gestaltung. In English, the Technical Report is called: Medical devices – Part 2: Guidance on the application of usability engineering.

IEC TR 62366-2 focuses on providing guidance and instruction for the human-centered design process. (For more information, see the chapter “How does IEC 62366-1 relate to IEC TR 62366-2?”).

The goal of this Technical Report is to provide medical device manufacturers with a clear framework for the practical implementation of human-centered design principles and practices. It supports the effort to make medical devices as safe and effective as possible and to minimize the risk of errors or accidents caused by usability issues.

 

For whom is the IEC TR 62366-2 relevant?

IEC TR 62366-2 is particularly relevant for the following persons (groups):

  • Manufacturers of medical devices: As a manufacturer, you will find IEC TR 62366-2 a practical companion for implementation and documentation of the usability engineering process.
  • Usability and Usability Experts: As a usability and usability expert you will also benefit from the pragmatic suggestions for the implementation of Usability Engineering. For example, you will be provided with suitable methods for each step of the process.
  • Also relevant for Notified Bodies. Although IEC TR 62366-2 is “only” a guide for everyone involved in the development of medical devices, it can serve as a guideline for Notified Bodies as to what is considered good practice.

 

What are the contents?

With regard to the usability of your medical device, we have summarized the most important assistance provided by IEC TR 62366-2.

  • You will get help on the design of displays, arrangement of buttons, design of menus, etc. always with reference to the consideration of the capabilities and characteristics of the users.
  • IEC TR 62366-2 lists methods and procedures for implementing all steps of the usability engineering process (e.g. for formative evaluations). Appendix E is particularly interesting for you here.
  • It gives examples of a usability test plan and provides general tips for integrating usability engineering into the development of the medical device. (Chapters 1 through 7).
  • Assistance is given on how to properly document the usability engineering process.
  • Examples of typical usability errors are also provided.
  • Specific sources are given to help developers find already known usage problems.

 

Which version is the latest?

The latest version is DIN EN 62366-2:2016-004, which is available from Beuth Verlag.

How does IEC 62366-1 relate to IEC 62366-2?

Both standards emphasize the importance of usability engineering in the design of medical devices. However, the objectives are different:

While IEC 62366-1 presents the process of usability engineering and thus describes what the analysis, specification, design and evaluation of the usability of medical devices must include, IEC TR 62366-2 provides clear implementation options for these points. In other words, it gives suggestions on how these requirements can be implemented in practice.

Example: If IEC 62366-1 suggests that you can use formative evaluations to iteratively improve your medical device, IEC TR 62366-2 helps you find the right methods to do so. The suggestions for this in Annex E are varied, including Contextual Inquiries, Observations, Interviews, and Task Analyses.

 

Conclusion

IEC TR 62366-2 is relevant for all bodies involved in the approval of the medical device. It is the perfect guidance document for all medical device manufacturers and usability experts who want to implement a usability engineering process according to IEC 62366-1.

Especially exciting is the assistance provided in Appendix E. Here you can find all suitable methods for the respective steps of the usability engineering process. The examples of suitable documentation can also be of great help.

If you want to have a comprehensive understanding of IEC 62366-1 and IEC TR 62366-2, we recommend that you also read our article on IEC 62366-1.

How can we help you with Usability Engineering for medical devices? Get in touch via our contact form. We look forward to hearing from you.

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