Study on Reliability Assessment for the Medical Device Software from the Viewpoint of Functional Safety
![]() |
Kim, Sung Min
(Korea Testing Laboratory)
Ko, Byeonggak (Korea Testing Laboratory) Do, Gyeong-Hun (Korea Testing Laboratory) Kim, Hye Jin (Korea Testing Laboratory) Ham, Jung-Keol (Korea Testing Laboratory) |
1 | Korea Communications Agency (2013). "Technology Trend of the safety standards for Hardware and Software of the IT convergence industry". Issues and Outlook of the Broadcasting Communication Technology, No. 19 |
2 | Jang, S. Y. (2015). "Discussion on the application method of standard for functional safety of road vehicles(ISO 26262) from the viewpoint of software testing for the safety software". Journal of Korean Institute of Information Scientists and Engineers, Vol. 33, No. 7, pp. 27-32. |
3 | Dailymedi (2015). "Urgency of improvement for the quality control of the medical device software". |
4 | Park, S. O. and Yang, H. S. (2007). "Reliability Evaluation Method of Software for Electronic Medical Devices". Journal of the Korea Academia-Industrial coopertion Society, Vol. 88, No. 4, pp. 758-767. |
5 | Huhn, M. and Zechner, A. (2010). "Arguing for Software Quality in an IEC 62304 Compliant Development Process". Leveraging Applications of Formal Methods, Verification, and Validation, 4th, Springer, Vol. 6416, pp. 296-311. |
6 | Storey, N. (1996). "Safety-critical Computer Systems". Addison-Wesley. |
7 | MTL Instruments Group plc (2002). "An introduction to Functional Safety and IEC 61508". |
8 | Smith, D. J. and Simpson, K. (2004). "Functional Safety". Elsevier Butterworth-Heinemann. |
9 | Kang, H. D. (2012). "Comparison on the standards for functional safety of software from the viewpoint of software testing". Journal of Korean Institute of Information Scientists and Engineers, Vol. 30, No. 2, pp. 62-71. |
10 | KFDA. (2007). "Guidelines for Software Validation of Medical devices". Korea Food & Drug Administration. |
11 | IEC 62304. (2006). "Medical device software - Software life cycle processes". International Electro-technical Commission. |
12 | Watson, H. and McCabe, T. J. (1996). "Structured Testing: A Testing Methodology Using the Cyclomatic Complexity Metric". National Institute of Standards and Technology. |
13 | ISO/IEC/IEEE 29114-4. (2015). "Software and systems engineering-software testing-Part 4: Test techniques". International Organization For Standardization. |
![]() |