발간년도 : [2018]
| 논문정보 |
|
| 논문명(한글) |
[Vol.13, No.1] Development of a Medical Software Test System based on IEC 62304, IEC 60601-1, ISO 14971 |
|
| 논문투고자 |
A-Young Park, Ki-Won Song, Jeong-Hwan Park |
|
| 논문내용 |
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. |
|
| 첨부논문 |
|
|
|
|
|
자료실 > 논문지 
