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一种基于模型的方法来支持医疗信息物理系统的验证。

A Model-Based Approach to Support Validation of Medical Cyber-Physical Systems.

作者信息

Silva Lenardo C, Almeida Hyggo O, Perkusich Angelo, Perkusich Mirko

机构信息

Embedded Systems and Pervasive Computing Laboratory, Federal University of Campina Grande, 882 Aprígio Veloso Street, Universitário, Campina Grande 58429-900, Brazil.

出版信息

Sensors (Basel). 2015 Oct 30;15(11):27625-70. doi: 10.3390/s151127625.

DOI:10.3390/s151127625
PMID:26528982
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4701248/
Abstract

Medical Cyber-Physical Systems (MCPS) are context-aware, life-critical systems with patient safety as the main concern, demanding rigorous processes for validation to guarantee user requirement compliance and specification-oriented correctness. In this article, we propose a model-based approach for early validation of MCPS, focusing on promoting reusability and productivity. It enables system developers to build MCPS formal models based on a library of patient and medical device models, and simulate the MCPS to identify undesirable behaviors at design time. Our approach has been applied to three different clinical scenarios to evaluate its reusability potential for different contexts. We have also validated our approach through an empirical evaluation with developers to assess productivity and reusability. Finally, our models have been formally verified considering functional and safety requirements and model coverage.

摘要

医疗网络物理系统(MCPS)是情境感知、关乎生命的系统,主要关注患者安全,需要严格的验证流程以确保符合用户需求和面向规范的正确性。在本文中,我们提出了一种基于模型的方法用于MCPS的早期验证,重点在于提高可重用性和生产率。它使系统开发人员能够基于患者和医疗设备模型库构建MCPS形式模型,并在设计时对MCPS进行模拟以识别不良行为。我们的方法已应用于三种不同的临床场景,以评估其在不同情境下的可重用潜力。我们还通过与开发人员进行实证评估来验证我们的方法,以评估生产率和可重用性。最后,我们的模型已根据功能和安全要求以及模型覆盖范围进行了形式验证。

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