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Efficient Approaches of Functional Safety for Medical Equipment using Essential Performance Analysis  

Kim, Gi-Young (Department of Industrial Engineering, Ajou University)
Yoo, Ki-Hoon (Department of Industrial Engineering, Ajou University)
Park, Ho-Joon (Medical Device Evaluation Center, Korea Testing Laboratory)
Jang, Joong-Soon (Department of Industrial Engineering, Ajou University)
Publication Information
Journal of Applied Reliability / v.15, no.1, 2015 , pp. 27-32 More about this Journal
Abstract
Functional safety is part of the overall safety relating to the equipment under control (EUC) and the EUC control system that depends on the correct functioning of the electrical/electronic/programmable electronic (E/E/PE) safety-related systems. Since the complexity of the medical equipment is increased, manufactures have to obtain functional safety as well as basic safety. This study proposes a perspective for applying functional safety to medical equipment. The research is carried out with respect to overall safety life-cycle of functional safety and essential performance of the medical equipment. The relationship between functional safety and essential performance is identified centered on the safety function. The essential performance using E/E/PE systems is defined as a safety function of functional safety. This approach is applied to a ultrasound imaging system as a case study.
Keywords
Functional Safety; Essential Performance; Risk Management; Medical Equipment; Ultrasound Imaging System;
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Times Cited By KSCI : 1  (Citation Analysis)
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