| Summary: | 碩士 === 華梵大學 === 工業工程與經營資訊學系碩士班 === 94 === Biomedical technologies have been in rapid development due to the aging population in all of the developed and developing countries. At the same time, the safety concern and associated regulations of medical equipment are becoming an important subject area due to the high relevancy to human life.
Such a safety implementation on medical instrumentation will rely on comprehensive risk management and execution of HBSE (Hazard -Based Safety Engineering). Unfortunately, the industries are adopting procedures of their own choices, indicating the fact that there is no integrated, and standardized, procedures in place. The purpose of this research is to venture into exploring applicable risk management and HBSE procedures for the related industries. One of the key conclusions is that procedures of risk management could be an effective tool for risk control and management. The paper uses the development of patient lift as the case study and has identified a disciplined list of test and measurement through HSBE. Another critical conclusion is that, with the use of HBSE, one could reach a balance between safety requirements and applicability and cost of medical products.
Businesses can reduce the chance of re-work while increase developmental efficiency through the use of tools of risk management and HBSE. A set of standardized procedures is needed for its application. The paper further suggests a procedure flow to assist medical and healthcare industries in this regard.
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