휴대형 심전도 분석 소프트웨어 사용자 인터페이스의 위험 기반 휴리스틱 평가 프레임워크 제안

Abstract

In Korea, Usability evaluation is being applied in phases to all medical devices. Accordingly, medical device manufacturers are required to identify potential use errors during the design and development process and improve them to ensure the safety and effectiveness of their devices. While international standards such as IEC 62366-1,2 as well as certain guidelines from the Ministry of Food and Drug Safety (MFDS), provide references, further research is necessary to derive evaluation items that reflect the characteristics of each product. Therefore, this study proposes a usability evaluation method for portable electrocardiogram (ECG) analysis software, which is increasingly used due to the rise in aging populations and chronic disease patients. Based on the usage procedures of domestically approved products, Perception, Cognition, and Action (PCA) analysis was conducted, and heuristic evaluation items were derived using Jakob Nielsen’s ten usability heuristics. Subsequently, risk assessment was carried out based on the software safety classification criteria of IEC 62304, and final heuristic evaluation items were selected. The proposed heuristic evaluation items are expected to serve as a useful formative evaluation reference for manufacturers in designing and refining user interfaces of their products.