Journal of the Korean Society of Safety (한국안전학회지)

The Korean Society of Safety (한국안전학회)
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Application of Risk Management for Dental Implants Based on ISO 14971

치과용 임플란트에 대한 ISO 14971 기반의 리스크관리

  • Yoon, Ji-Hoon (Implant Research Center, Osstem Implant Co.) ;
  • Kim, Young-Jin (College of Engineering, Dept. of Systems Management and Engineering, Pukyong National University) ;
  • Jeon, Gye-Rok (Dept. of Biomedical Engineering, School of Medicine, Pusan National University) ;
  • Jeong, Chang-Mo (Dept. of Prosthodontics, School of Dentistry, Pusan National University)
  • 윤지훈 (오스템임플란트(주) 임플란트연구소) ;
  • 김영진 (부경대학교 공과대학 시스템경영공학과) ;
  • 전계록 (부산대학교 의학전문대학원 의공학과) ;
  • 정창모 (부산대학교 치의학전문대학원 보철과)
  • Received : 2011.12.07
  • Accepted : 2012.03.19
  • Published : 2012.04.30
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Abstract

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.

Keywords

References

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