Architecture Reconstruction and Analysis of Medical Device Software

2011 Ninth Working IEEE/IFIP Conference on Software Architecture Pub Date : 2011-06-01 DOI:10.1109/WICSA.2011.33

D. Ganesan, M. Lindvall, R. Cleaveland, R. Jetley, P. Jones, Y. Zhang

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引用次数: 9

Abstract

New research is underway at the FDA to investigate the benefits of integrating architecture analysis into safety evaluations of medical-device software. Due to the complexity in setting up testing environments for such software, the FDA is unable to conduct large-scale safety testing, instead, it must rely on other techniques to build an argument for whether the software is safe or not. The architecture analysis approach, formalized using relational algebra, is based on reconstructing abstract, yet precise, architectural views from source code to help build such arguments about safety. This paper discusses the use of the formal approach to analyze the Computer-Assisted Resuscitation Algorithm (CARA) software, which controls an infusion pump designed to provide automated assistance for transfusing blood. The results suggest that a) architecture analysis offers many insights related to software quality in general and testability (i.e., the ease of testing) and its impact on safety in particular, and b) architectural analysis results can be used to help configure static analysis tools to improve their performance for verifying safety properties.

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医疗器械软件体系结构重构与分析

FDA正在进行一项新的研究，以调查将架构分析整合到医疗设备软件的安全评估中的好处。由于为此类软件设置测试环境的复杂性，FDA无法进行大规模的安全测试，相反，它必须依靠其他技术来建立软件是否安全的论据。使用关系代数形式化的体系结构分析方法基于重构源代码中的抽象但精确的体系结构视图，以帮助构建有关安全性的论证。本文讨论了使用形式化方法来分析计算机辅助复苏算法(CARA)软件，该软件控制输液泵，旨在为输血提供自动辅助。结果表明，a)体系结构分析提供了许多与软件质量和可测试性(即，测试的便捷性)及其对安全性的影响相关的见解，b)体系结构分析结果可用于帮助配置静态分析工具，以改进其验证安全属性的性能。

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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2011 Ninth Working IEEE/IFIP Conference on Software Architecture

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