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http://dx.doi.org/10.7472/jksii.2021.22.6.59

A Safety Process Guideline of Medical Device System Based on STPA  

Choi, Bo-yoon (Department of Information Security, Seoul Women's University)
Lee, Byong-gul (Department of Data Science, Seoul Women's University)
Publication Information
Journal of Internet Computing and Services / v.22, no.6, 2021 , pp. 59-69 More about this Journal
Abstract
Malfunctions and failures linked to medical devices may result in significant damage for human being. Thus, in order to ensure that safety of medical device is achieved, it should be established and applied the international standard. It is required to integrate and customize activities at standards, owing to reference relationship between standards, especially, activities based safety analysis is too expensive. This paper proposes a integration process that integrate activities of development lifecycle and safety process. Additionally, we derived a guidance based on STPA for integration process. As a result, we can be performed systematically from early stage of the development and increased effectiveness of integration process by the guidance.
Keywords
Medical device Software; Safety process; STPA;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
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