THE ROLE OF ERGONOMICS AND SAFETY REQUIREMENTS IN THE DESIGN OF MEDICAL DEVICES
Abstract
This article explores the crucial role of ergonomics and safety requirements in the design and development of modern medical devices. It emphasizes that well-designed medical equipment must not only meet technical and functional standards but also ensure comfort, efficiency, and safety for both healthcare professionals and patients. The paper discusses key ergonomic principles—such as usability, human–machine interaction, and accessibility—that help reduce user fatigue, prevent errors, and improve overall performance in clinical environments. Furthermore, it highlights international safety regulations and quality control standards, including ISO 13485, IEC 60601, and FDA guidelines, which define the framework for ensuring device reliability and patient safety. The study also presents innovative approaches in biomedical engineering that integrate human-centered design, risk assessment, and simulation technologies to create safer, more effective, and user-friendly medical devices. Ultimately, the article underscores that applying ergonomics and safety requirements in medical device design is essential for enhancing healthcare quality, minimizing risks, and ensuring sustainable development in the medical technology industry.
Keywords
Ergonomics, medical devices, safety requirements, design, user comfort, human–machine interaction, quality control, ISO 13485, IEC 60601, FDA standards, biomedical engineering, risk assessment, simulation technology, healthcare, sustainable development.
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