植入式心脏起搏器系统验证方法的研究

摘要

目的 植入式医疗器械的安全性、可靠性以及系统验证的完整性要求极高,对于第三类医疗器械,在系统验证的过程中,需要提供足够的证据证明器械的需求得到了满足.本文提出一种基于植入式心脏起搏器微处理器系统验证的方法.方法 采用将测试融入设计中的原则,测试数据和需求的关系是不变的,如果可以在不同的阶段收集到相似的数据,就可以将单元测试和集成测试与系统验证结合起来.本文以起搏器工作于AAI模式为例进行了三组实验,并且将得到的实验数据解析,分析数据和需求之间的关系,详细描述该方法的实现方式.结果 实验表明,该方法能有效完成系统功能验证和固件测试,并且能够应用于起搏器研发的不同阶段.结论 测试融入设计方法可为对安全性及可靠性要求较高、与起搏器系统类似的产品的开发提供借鉴.%Objective The demands of safety,reliability and system integrity for implantable medical devices are very high.As a class three medical device,we need to provide evidences that all engineer requirements are satisfied as part of system verification process.A design for testability methodology is presented for a microprocessor based on implantable pacemaker. Methods Because of the relationships between data and requirements are invariants,If we manage to collect similar data at difforent stages of firmware development,we may coordinate the unit and integration tests with system verification activities.We complete three experiments based on AAI mode as an example,analyze the test data and the relationships between data and requirenmnts.Results The experimental results show that the method effectively completes the system flmctional verification and firmware test at different stages of firmware development.Conclusions This method can be used in systems with high safety and reliability requirement which are similar to cardiac pacemaker.