Application of Risk Management for Dental Implants Based on ISO 14971 |
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) |
1 | ISO, ISO 14971:2007 Medical devices - Application of risk management for medical devices, ISO, 2007. |
2 | N. Givol, S. Taicher, et al., "Risk Management Aspects of Implant Dentistry", Int. J. Oral Maxillofac. Implants, Vol. 17, pp. 258-262, 2002. |
3 | W. Cheung, "Risk Management in Implant Dentistry", Hong Kong Dent. J., Vol. 2, pp. 58-60, 2005. |
4 | IEC, IEC 61025 Fault Tree Analysis (FTA), IEC, 2006. |
5 | IEC, IEC 60812 Analysis techniques for system reliability - Procedures for failure mode and effect analysis (FMEA), IEC, 2006. |
6 | IEC, IEC 61882 Hazard and operability studies (HAZOP studies) - Application guide, IEC, 2001. |
7 | G. Flick, J.L. Salyer, et al., Medical Device Risk Management Training Using HACCP Principles, 2nd ed., Medical HACCP Alliance, 2003. |