IEC 62366 Usability Engineering for Medical Devices and its relationship with ISO 9241-210 Human-Centered Design

 

 

Usability is a critical factor in medical device design, as it directly affects user performance, patient safety, and overall effectiveness. The IEC 62366 standard establishes a usability engineering process for medical devices, ensuring that they are designed with the user in mind to minimize use-related risks. Meanwhile, ISO 9241-210 defines human-centered design (HCD) principles, which provide a broader framework for usability considerations even beyond medical devices. A third very important component is the ISO 9241-11 standard where Usability is defined.

 

These standards share common principles, and their integration strengthens usability engineering by aligning risk management with usability & user experience (UX) design methodologies.

 

This article explores the relationship between IEC 62366, ISO 9241-210 and ISO 9241-11, focusing on usability evaluation methods, particularly usability testing, cognitive walkthroughs, and formative and summative evaluations.

 

 

Overview of IEC 62366

 

IEC 62366 provides a structured approach to usability engineering in medical devices, ensuring they are safe and effective for intended users. The key objectives of this standard are:

• Minimizing use-related risks that could lead to harm.

• Ensuring usability engineering is part of risk management in compliance with ISO 14971 (Risk Management for Medical Devices).

• Enhancing device effectiveness by making them easier to use.

 

Key Components of IEC 62366

 

IEC 62366 defines a usability engineering process that includes:

1. User research - Conduct contextual inquiries and focus groups.

2. Analysis -  Identify characteristics for safety & identify hazards & describe & categorize hzard related use scenarios.

3. Design - Establish evaluation plan & establish user interface specification & implement and conduct formative evaluations and iterate.

4. Summative Evaluations – Summative usability evaluations including usability test when the product is about to be finalized and released.

 

 

 

Overview of ISO 9241-210

 

ISO 9241-210 provides a framework for designing interactive systems that prioritize user needs and usability throughout the development lifecycle. The standard promotes an iterative design process that includes:

1. Context of use - Analyze and specify context of use according to the model depicted in ISO 9241-11

2. Specifying user needs and user requirements - Understand what the user needs to take a decision.

2. Designing solutions based on user requirements - Develop designs and creating prototypes and refining design.

3. Evaluating designs iteratively – Using usability evaluations to refine the system until all requirements are met.

 

 

• The design is based on a thorough understanding of the context of use.

• User involvement throughout development.

• Iterative design and evaluation. 

• Focus on the entire user experience.

• Risk reduction through user testing and evaluation.

• Interdisciplinary knowledge and perspectives are represented in the design team.

 

 

 

• Context of use - User, Goal, Task, Evironment, Ressources

• Result of use - Results with respect to usability and other results

• Results related to usability - Effectiveness, efficiency, satisfaction

• Other results - User experience, avoidance from harm, accessability

 

 

Both standards emphasize usability, risk reduction, and iterative evaluation, making them complementary in medical device design. IEC 62366 adopts human-centered design principles from ISO 9241-210, particularly in:

1. User Needs and Use Scenarios

• IEC 62366 requires defining intended users, environments, and scenarios to identify potential hazards.

• ISO 9241-210 provides methodologies for understanding user needs through observations, interviews, and task analysis.

2. Iterative Usability Evaluation

• IEC 62366 mandates formative and summative evaluations to verify safe and effective use.

• ISO 9241-210 prescribes iterative usability testing to refine designs based on user feedback.

3. Risk Management and Usability

• IEC 62366 integrates usability with risk management (aligned with ISO 14971).

• ISO 9241-210 focuses on preventing user errors through human-centered design strategies.

 

By combining these three standards, medical device manufacturers ensure that their products are both safe (IEC 62366) and user-friendly (ISO 9241-210 ISO 9241-11).

 

The Role of Usability Evaluation in Medical Device Design

 

Usability evaluation is central to both IEC 62366 and ISO 9241-210. The goal is to ensure that the medical device supports users in performing their tasks efficiently and safely. The two main usability evaluation methods used in usability engineering are usability testing and cognitive walkthroughs, which support both formative and summative evaluations.

 

 

IEC 62366 and ISO 9241-210 are closely linked, as both emphasize usability, human-centered design, and iterative evaluation. While IEC 62366 specifically addresses medical device usability and safety, ISO 9241-210 provides broader human-centered design principles that reinforce usability engineering best practices.

 

Usability evaluation plays a crucial role in both standards, ensuring that medical devices:

• Are easy to use.

• Minimize risks associated with human error.

• Provide a safe and effective user experience.

 

By integrating usability testing, cognitive walkthroughs, and both formative and summative evaluations, medical device manufacturers can enhance user satisfaction while meeting regulatory requirements.

 

 

 Related course: Usability Engineer Medical Devices IEC 62366 CPUX-F ENGLISH in the afternoon UA3090