A few things you need to know about the IEC 62366-1 standard for medical device development

By Human Factors Team

Human-machine interaction in health care should not be taken lightly. Poor medical device design can cause tragic and sometimes fatal use errors. To prevent these kinds of incidents, the IEC 62366-1 standard on usability engineering for medical devices was created.

The human factors & user experience team at CLEIO, which is well versed in usability engineering methodologies, summarizes the essentials here.

A brief definition of usability

Usability is the extent to which a product can be used by specified users to achieve specified goals with success and satisfaction in a specified context of use.
For IEC 62366-1, usability is assessed based on the following main criteria:


The accuracy and completeness with which a goal is achieved (e.g., the user injects the correct dose of an intravenous drug).


The resources required to achieve a goal (e.g., the time a user needs to correctly configure an infusion pump).


The lack of discomfort and positive attitude about using the device.


The time and effort needed to become familiar with the device and how it works.

The user interface is much more than what’s on screen

In usability engineering, the term “user interface” covers all the ways in which the user and device can interact, from hardware to software. In addition to graphical user interfaces (GUIs), this definition includes all formal aspects, weights, dimensions, textures, sounds, etc.

It’s worth noting that instructions and training are also considered part of the user interface, since they affect its use.

A process inspired by user experience (UX) methods

Whether it’s to define the user needs and use environment, carry out a risk analysis, or perform formative and summative evaluations, the user experience (UX) methods recommended by IEC 62366-1 are essential to the usability engineering process:

Formative evaluations, or why it’s normal to not immediately get a satisfactory result

Under IEC 62366-1, adopting an iterative approach is crucial: creating multiple versions of the solution before going to market is a must.

Once a prototype can be put together, whether that’s a conceptual model for a graphic user interface or a volumetric model for a physical product, an initial formative evaluation should be conducted. The findings are recorded, the design is improved, and a subsequent evaluation is carried out.

The summative evaluation, or the final exam

The IEC 62366-1 standard requires a summative evaluation, which is the final step of the process. This evaluation aims to gather objective evidence that the product can be used safely.
To do that, the use of the medical device should be simulated with at least 15 participants from each profile.

The testing conditions should mimic the real context of use as closely as possible, including for training and documentation.

The goal: design products that are safe to use

The goal of the IEC 62366-1 standard is to design a device’s user interface minimizing the risk of use errors by implementing a user-centered iterative design process. Although the process itself is presented as a recommendation, manufacturers are obligated to provide objective evidence that a device is safe to use.

Applying the recommended methodology throughout the product development process increases the chances of designing a safe product, and therefore obtaining certification from regulators.

Learn more about the IEC 62366-1 standard


10 things you need to know about IEC 62366-1 for Medical Device Development

Stop making costly Medical Device Development mistakes! 💥 Increased development times, improved sales, higher user satisfaction, those are just a few of the benefits of applying IEC 62366-1. Download our free guide made by experts.

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