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Application of Risk Management for Dental Implants Based on ISO 14971
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  • Application of Risk Management for Dental Implants Based on ISO 14971
저자명
윤지훈,김영진,전계록,정창모,Yoon. Ji-Hoon,Kim. Young-Jin,Jeon. Gye-Rok,Jeong. Chang-Mo
간행물명
한국안전학회지
권/호정보
2012년|27권 2호|pp.92-97 (6 pages)
발행정보
한국안전학회
파일정보
정기간행물|
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Risk management is the process that helps to identify hazards, analyze them, and then to create an action plan to avoid and mitigate these hazards. The main objective of risk management in product development and manufacturing is to provide safe and efficient products without spending too many resources. Medical device manufacturers also face enormous risks - regulatory, legal, and financial - based on their products and processes, and the concepts of risk management are particularly important because any single failure may result in serious damages to body or loss of life. In this regard, a set of guidelines for the application of risk management to medical devices has been issued by ISO and specified in the document ISO 14971 Medical devices - Application of risk management to medical devices. The main objective of this study is to investigate the application of risk management to dental implant development and manufacturing processes based on ISO 14971. A general risk management process is first introduced, and the application of ISO 14971 to dental implants is further investigated.