The Application of Risk Management to Medical Software Example of the Picture Archiving and Communication System

K. M. Jen

《危機管理學刊》 7卷2期 (2010/09) Pp. 1-10

https://doi.org/10.6459/JCM.201009_7(2).0001

並列摘要

Medical devices are significant risk when, among other things, they could be implant, invasive, life-supporting, or substantially important for diagnosing, curing, mitigating, treating, or preventing impairment of humans. Especially, medical soft-ware is a specialized branch of software engineering in which the software is used to monitor or control patient functions and records. Once a malfunction or a latent design flaw in the software of medical device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to injury, even serious harm or death. According to ISO14971 for risk management of medical device, this paper attempts to analyze the example of the Picture Archiving and Communication System (PACS). All of the risks would be implemented the analysis and done the necessary control by the ISO14971 relevant procedures; and any undesirable hazards would have been reduced to the acceptable levels.

並列關鍵字

Picture Archiving ； Communication System PACS

參考文獻

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British Standards Institution(2007).EN ISO14971 Medical devices-Application of risk management to medical devices.England:British Standard.