A Safety Process Guideline of Medical Device System Based on STPA

Bo-yoon Choi; Byong-gul Lee

A Safety Process Guideline of Medical Device System Based on STPA

Bo-yoon Choi, Byong-gul Lee, Journal of Internet Computing and Services, Vol. 22, No. 6, pp. 59-69, Dec. 2021

10.7472/jksii.2021.22.6.59, Full Text:

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Keywords: Medical Device Software, Safety process, STPA

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.

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Cite this article

[APA Style]

Choi, B. & Lee, B. (2021). A Safety Process Guideline of Medical Device System Based on STPA. Journal of Internet Computing and Services, 22(6), 59-69. DOI: 10.7472/jksii.2021.22.6.59.

[IEEE Style]

B. Choi and B. Lee, "A Safety Process Guideline of Medical Device System Based on STPA," Journal of Internet Computing and Services, vol. 22, no. 6, pp. 59-69, 2021. DOI: 10.7472/jksii.2021.22.6.59.

[ACM Style]

Bo-yoon Choi and Byong-gul Lee. 2021. A Safety Process Guideline of Medical Device System Based on STPA. Journal of Internet Computing and Services, 22, 6, (2021), 59-69. DOI: 10.7472/jksii.2021.22.6.59.