典型呼吸治疗设备关键参数的测量不确定度研究  

Research on Measurement Uncertainty of Key Parameters of Typical Respiratory Therapy Equipment

作　　者：付强 FU Qiang(Shanghai Institute of Medical Device Testing,Shanghai,200318;NMPA Key Laboratory of Anaesthetic and Respiratory Equipment,Shanghai,200318)

机构地区：[1]上海市医疗器械检验研究院,上海市200318 [2]国家药品监督管理局呼吸麻醉设备重点实验室,上海市200318

出　　处：《中国医疗器械杂志》2022年第6期673-680,共8页Chinese Journal of Medical Instrumentation

摘　　要：该研究根据GB 9706.212—2020《医用电气设备第2-12部分:重症护理呼吸机的基本安全和基本性能要求》、YY 9706.270—2021《医用电气设备第2-70部分:睡眠呼吸暂停治疗设备的基本安全和基本性能专用要求》和YY 9706.274—2022《医用电气设备第2-74部分:呼吸湿化设备的基本安全和基本性能专用要求》等呼吸治疗设备的行业标准中关于产品声称公差的测量不确定度要求,分别介绍和分析了治疗呼吸机、睡眠呼吸暂停治疗设备和湿化器关键参数的不确定度的评定过程,给出具体的不确定度来源和分析结果,以期为医疗器械检测实验室满足质量管理中不确定度的相关要求提供建议,或为相关制造商满足行业标准的要求提供一定的帮助。According to the measurement uncertainty requirements of the key parameters of the declared tolerances of the products in the industrial standards of respiratory therapy equipment such as GB 9706.212—2020 Medical electrical equipment—Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators,YY 9706.270—2021 Medical electrical equipment—Part 2-70:Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment,and YY 9706.274—2022 Medical electrical equipment—Part 2-74:Particular requirements for basic safety and essential performance of respiratory humidifying equipment,this study introduces and analyzes the evaluation process of the uncertainty of the key parameters of critical care respiratory,sleep apnoea breathing therapy equipment,and humidifier,and it gives the sources and results of measurement uncertainty.It is expected that it can provide suggestions for the medical device testing laboratory to meet the uncertainty requirements of quality management and provide references for relevant manufacturers to meet the requirements of industrial standards.

关 键 词：呼吸治疗设备 潮气量 静态气道压力 湿化输出 测量不确定度 

分 类 号：TM930.12[电气工程—电力电子与电力传动]