A proposal on the standardization of robotic wheelchair

This study proposes an integrated standardization framework to comprehensively evaluate the safety, performance, and autonomy levels of robotic wheelchairs, enabling individuals with severe physical disabilities and brain injuries to move safely and autonomously in South Korea's aging society. The core requirements were derived through analysis of major domestic and international standards and guidelines including ISO 7176 series and IEC 80601-2-78. A LOA (Level of Autonomy) 0-5 grading system was established by modifying the automotive SAE J3016 model to suit medical and welfare environments. Risk scenarios were developed for each LOA grade, and FMEA and ISO 14971 procedures were integrated to enable design-stage risk management. The standardization criteria presented in this study are expected to contribute to ensuring user safety, simplifying public procurement procedures, and promoting international market entry by supporting the development of manufacturer design and testing guidelines. The framework can also be utilized in licensing review criteria, license examination standards, and ISO/TC 173 SC 1/WG 10 international standard discussions.