의료기기 멸균을 위한 전자빔의 품질 및 일상관리 기술
Quality and Routine Control Technology of Electron Beam for Sterilization of Medical Devices
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Quality control of medical devices consists of several factors such as documentation, management obligations, experimental prototype and its measurement, analysis and its improvement activities. In documentation, all procedures for the sterilization process should be recorded the document in which are preparation, testing, routine control and product shipment. The management obligations should be clearly specified the obligations and authority for compliance with the requirements, and selected the appropriate person for the performance of the obligations. Experimental prototype and its measurement should be clarified the purchasing procedure, and the identification and tracking procedures of the product should be clear. Equipment, including instruments used for testing purposes, should be calibrated to meet the requirements of the standard. Dose measurement used for the production, specification and routine control in the sterilization process of medical devices using electron beam accelerator should be measurable and traceable according to international standards. Analysis and its improvement were performed quality control of medical devices by clarifying the procedures for the management procedures and calibration of permitted products, and for the corrective actions and preventive measures.
Abstract
Quality control of medical devices consists of several factors such as documentation, management obligations, experimental prototype and its measurement, analysis and its improvement activities. In documentation, all procedures for the sterilization process should be recorded the document in which are preparation, testing, routine control and product shipment. The management obligations should be clearly specified the obligations and authority for compliance with the requirements, and selected the appropriate person for the performance of the obligations. Experimental prototype and its measurement should be clarified the purchasing procedure, and the identification and tracking procedures of the product should be clear. Equipment, including instruments used for testing purposes, should be calibrated to meet the requirements of the standard. Dose measurement used for the production, specification and routine control in the sterilization process of medical devices using electron beam accelerator should be measurable and traceable according to international standards. Analysis and its improvement were performed quality control of medical devices by clarifying the procedures for the management procedures and calibration of permitted products, and for the corrective actions and preventive measures.
참고문헌 (16)
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