Glossary Term
ISO 62366 (Medical Devices – Application of Usability Engineering to Medical Devices)
Definition
ISO 62366 is an international standard that establishes a usability engineering process for medical devices. It aims to identify and mitigate risks associated with device use, ensuring that devices are safe, effective, and easy to operate in real-world clinical and home environments.
Relevance to the MedTech Industry
ISO 62366 ensures that medical devices are designed with the user in mind, addressing potential errors and usability challenges. By prioritizing human factors, the standard enhances device safety, reduces the likelihood of use-related adverse events, and supports regulatory compliance.
Additional Information & Related Terms
Key Components of ISO 62366
Usability Engineering Process
Defines steps for identifying and mitigating risks related to device usability.
Use-Related Risk Analysis
Focuses on identifying potential use errors and their associated risks, linking closely to ISO 14971 risk management.
User Interface Design and Evaluation
Ensures that device interfaces, including controls, displays, and labeling, are intuitive and minimize the potential for errors.
Validation of Usability
Requires testing with representative users in simulated environments to confirm safe and effective use.
Related Terms
Risk Management (ISO 14971): Usability engineering links directly to identifying and mitigating use-related risks.
Human Factors Engineering (HFE): A broader discipline closely aligned with ISO 62366, focusing on designing systems that align with human capabilities and limitations.
Instructions for Use (IFU): Usability principles influence the design of user-friendly instructions, as guided by ISO 20417.
Post-Market Surveillance (PMS): Usability data from real-world use informs ongoing risk mitigation and product improvement.