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@article{ART002318345},
author={A Young Park and Kiwon Song and Jeong-Hwan Park},
title={Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971},
journal={Journal of Knowledge Information Technology and Systems},
issn={1975-7700},
year={2018},
volume={13},
number={1},
pages={37-44},
doi={10.34163/jkits.2018.13.1.004}

TY - JOUR
AU - A Young Park
AU - Kiwon Song
AU - Jeong-Hwan Park
TI - Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971
JO - Journal of Knowledge Information Technology and Systems
PY - 2018
VL - 13
IS - 1
PB - Korea Knowledge Information Technology Society
SP - 37
EP - 44
SN - 1975-7700
AB - Medical devices are becoming increasingly intelligent with the development of the fourth industrial revolution. In case of defects in medical equipment and software, it is directly related to injury, so the testing process is very important. Therefore, Verification of new solution-level medical software (eg, personal care and preventive care through healthcare) is becoming important. In this paper, we developed a system for testing medical software. The system can manage tests based on international standards(IEC 62304, IEC 60601-1, ISO 14971), and check defect rates. In addition, the proposed system provides results in the form of reports so that test data can be accumulated and compared, analyze. Then, We have tested the Electronic Medical Record to verify the system. The system proposed in this paper can increase the satisfaction of the ease of use of the system through the quantitative data input and the reliability of the result value. Future research will require improvements to the system to be able to support Class B and Class C. By accumulating test data, We need to optimize for each medical device based on the frequency of exposure of risks.
KW - MSTS(Medical Software Test System);Testcase;Testing system;Quality assurance;Software process;QCD
DO - 10.34163/jkits.2018.13.1.004
ER -

A Young Park, Kiwon Song and Jeong-Hwan Park. (2018). Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971. Journal of Knowledge Information Technology and Systems, 13(1), 37-44.

A Young Park, Kiwon Song and Jeong-Hwan Park. 2018, "Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971", Journal of Knowledge Information Technology and Systems, vol.13, no.1 pp.37-44. Available from: doi:10.34163/jkits.2018.13.1.004

A Young Park, Kiwon Song, Jeong-Hwan Park "Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971" Journal of Knowledge Information Technology and Systems 13.1 pp.37-44 (2018) : 37.

A Young Park, Kiwon Song, Jeong-Hwan Park. Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971. 2018; 13(1), 37-44. Available from: doi:10.34163/jkits.2018.13.1.004

A Young Park, Kiwon Song and Jeong-Hwan Park. "Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971" Journal of Knowledge Information Technology and Systems 13, no.1 (2018) : 37-44.doi: 10.34163/jkits.2018.13.1.004

A Young Park; Kiwon Song; Jeong-Hwan Park. Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971. Journal of Knowledge Information Technology and Systems, 13(1), 37-44. doi: 10.34163/jkits.2018.13.1.004

A Young Park; Kiwon Song; Jeong-Hwan Park. Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971. Journal of Knowledge Information Technology and Systems. 2018; 13(1) 37-44. doi: 10.34163/jkits.2018.13.1.004

A Young Park, Kiwon Song, Jeong-Hwan Park. Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971. 2018; 13(1), 37-44. Available from: doi:10.34163/jkits.2018.13.1.004

A Young Park, Kiwon Song and Jeong-Hwan Park. "Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971" Journal of Knowledge Information Technology and Systems 13, no.1 (2018) : 37-44.doi: 10.34163/jkits.2018.13.1.004