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KMID : 1137820190400010020
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의공학회지
2019 Volume.40 No. 1 p.20 ~ p.31
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Establish Selection Process of Performance Management Medical Devices and Test items Based on Risk Management
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Park Ho-Joon
Jang Joong-Soon
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Abstract
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Medical device performance management is an activity that allows a device to be safely used and maintained even after it is put on the market. The purpose of this study is to provide procedures and criteria for selection of medical device items that should manage the safety and performance among medical devices in hospital. Investigate the performance management status of medical devices in hospitals and identify the performance management status by domestic and advanced regulatory agencies. Provides selection procedures and test methods for medical devices subject to performance management in hospitals based on medical device risk management and reliability. In addition, a case study on drug infusion pumps was conducted.
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KEYWORD
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Risk management, Hospital medical devices, Performance management, Criteria, Procedures
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