医疗器械开发中的软件风险分析

2011 37th EUROMICRO Conference on Software Engineering and Advanced Applications Pub Date : 2011-08-30 DOI:10.1109/SEAA.2011.65

Christin Lindholm, Jesper Pedersen Notander, Martin Höst

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引用次数: 5

摘要

在安全关键型软件的开发中，风险管理的目的是消除或减少有害行为。在医疗保健领域，由于在医疗设备和其他计算机系统中越来越多地使用软件，因此必须管理与软件有关的风险。本文介绍了从瑞典一家大医院正在进行的案例研究中获得的一些经验。该研究的重点是使用情景识别和分析风险，以及这种方法的有效性。该研究作为行动研究进行，目的是分析并为组织的新软件风险管理过程提供输入。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Software Risk Analysis in Medical Device Development

The purpose of risk management in the development of safety-critical software is to eliminate or reduce harmful behaviour. In health-care it is essential to manage risk related to software due to its increased use in medical devices and other computer systems. This paper presents some of the experiences gained from an ongoing case study at a large hospital in Sweden. The study focuses on identification and analysis of risks using scenarios and how effective this approach is. The research is conducted as action research, with the aim of analysing and giving input to the organisation's new software risk management process.

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2011 37th EUROMICRO Conference on Software Engineering and Advanced Applications

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