Glossary Term
ISO 9241-210 (Human-Centered Design for Interactive Systems)
Definition
SO 9241-210 is an international standard that outlines the principles and processes of human-centered design (HCD) for interactive systems. It focuses on designing systems that are user-friendly, meet user needs, and minimize the risk of use-related errors. The standard is widely applied in the development of software, hardware, and systems, including medical devices, to ensure safe, effective, and satisfying interactions.
Relevance to the MedTech Industry
ISO 9241-210 ensures that medical devices with interactive systems, such as user interfaces or control panels, are designed to align with the abilities, needs, and limitations of their users. This reduces the likelihood of user errors, improves device safety, and enhances the overall user experience in healthcare settings.
Additional Information & Related Terms
Key Components of ISO 9241-210
Human-Centered Design Process
Defines a process that incorporates user needs into the design and evaluation of interactive systems.
Principles of Human-Centered Design
Ensures designs are based on a clear understanding of users, tasks, and environments.
Actively involves users throughout the design and development process.
Iterative design to address usability issues before finalization.
Integration with Risk Management
Focuses on identifying and mitigating risks related to use errors and interface design.
Evaluation of Usability
Provides guidance for testing designs to ensure they meet defined usability objectives.
Examples of Applications
Patient Monitors: Intuitive interfaces that display critical data clearly and allow quick interaction during emergencies.
Infusion Pumps: Simple, error-proof programming of medication delivery to prevent dosing errors.
Surgical Robots: User-friendly controls to enable precise movements and reduce cognitive load during procedures.
mHealth Apps: Applications designed for patients to track health metrics, ensuring usability across diverse populations.
Related Terms
Usability Engineering (ISO 62366): Complementary standard for designing medical devices with a focus on usability.
Human Factors Engineering (HFE): Broader discipline that aligns with ISO 9241-210 to minimize use-related risks.
Risk Management (ISO 14971): Integrates with ISO 9241-210 to manage risks associated with human-device interactions.
Instructions for Use (IFU): User-focused documentation influenced by human-centered design principles.