摘要
为了解决医用模拟肺的质量控制和量值溯源问题,满足JJF 1234—2018《呼吸机校准规范》的校准条件要求,该文对医用模拟肺顺应性和气道阻力的测量装置及方法进行了研究。利用定体积主动活塞式技术,模拟人体呼吸过程,设计了一种医用模拟肺校准装置。通过比对实验可知,该装置与国外同类装置偏差为:对于肺顺应性小于0.4%,对于气道阻力小于0.7%。该装置可完成肺顺应性和气道阻力2个物理指标的校准,具备清晰完整的量值溯源路径,保证从源头进行质量控制,完善了呼吸机的校准工作,为相关计量部门及医疗机构开展呼吸系统类医用器械质检问题研究提供了参考和借鉴。
In order to solve the problems of quality control and traceability of medical test lung for meeting the calibration conditions of JJF 1234—2018 Calibration Specification for Ventilators,the calibration device and method are researched for compliance and airway resistance of medical test lung in this paper.A calibration device for medical test lung is designed using constant volume active piston technology to simulate human breathing.Through comparison experiment,the deviation between this device and the similar foreign device can be found.The deviation is lower than 0.4%for lung compliance and lower than 0.7%for airway resistance.The calibration of lung compliance and airway resistance can be completed by this device.This device has a clear and complete traceability path to ensure quality control from the source.The calibration of ventilator is improved.This paper provides a reference for related metrology departments and medical institutions to study on quality inspection of respiratory medical instruments.
作者
张婷婷
黄秋
廖旭辉
黄成刚
阮志龙
杨亚非
林滔
杨波
ZHANG Tingting;HUANG Qiu;LIAO Xuhui;HUANG Chenggang;RUAN Zhilong;YANG Yafei;LIN Tao;YANG Bo(Qinghai Red Cross Hospital,Xining,810000;National Institute of Measurement and Testing Technology,Chengdu,610021;Sichuan Instrument Technology Co.Ltd.,Chengdu,610000;Shaoxing Testing Institute of Quality and Technical Supervision,Shaoxing,312000;Dazhou Quality and Technical Supervision,Inspection and Testing Center,Dazhou,635002)
出处
《中国医疗器械杂志》
2023年第5期528-532,共5页
Chinese Journal of Medical Instrumentation
关键词
医用模拟肺
校准装置
顺应性
气道阻力
量值溯源
medical test lung
calibration device
compliance
airway resistance
metrological traceability
