血透设备计量技术规范对患者安全和质量效果的影响研究  

Study on the Influence of Hemodialysis Specifications on Patient Safety and Quality Effect

作　　者：张婧[1] 张伟欣 张斌[1] 张继东[1] ZHANG Jing;ZHANG Wei-xin;ZHANG Bin;ZHANG Ji-dong(Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200127)

机构地区：[1]上海交通大学医学院附属仁济医院,上海200127

出　　处：《中国医疗器械信息》2024年第20期172-175,共4页China Medical Device Information

摘　　要：本文针对血液透析设备的计量技术规范进行了深入探讨,重点分析了其对确保患者安全性和提升治疗质量的影响。文中指出,血液透析设备必须保证准确的血液和透析液流速,恒定的温度和压力,并且需要采取措施防止交叉感染。同时,设备的精确度和稳定性对提高治疗质量至关重要,包括对血液和透析液流速的监控和调节,透析器性能的评估等。此外,也探讨了国内外相关的医疗器械标准对血液透析设备的影响,如IEC 60601-2-16:1998、GB 9706.1-2007和YY/T 0316-2016,这些标准为血液透析设备的设计、制造和使用提供了重要的指导。最后,作者强调了设备的维护和校准对保持其最佳性能的重要性。This paper deeply discusses the measurement technical specifications of hemodialysis equipment,and focuses on its impact on ensuring patient safety and improving the quality of treatment.It states that hemodialysis equipment must ensure accurate blood and dialysate flow rates,constant temperature and pressure,and measures need to be taken to prevent cross-infection.At the same time,the accuracy and stability of the equipment are crucial to improve the quality of treatment,including the monitoring and regulation of blood and dialysate flow rate,the evaluation of dialyszer performance,etc.Moreover,we also explored the impact of relevant domestic and foreign medical device standards on hemodialysis devices,such as IEC 60601-2-16:1998,GB 9706.1-2007 and YY/T 0316-2016,which provide important guidance for the design,manufacture and use of hemodialysis devices.Finally,we emphasize the importance of the maintenance and calibration of the equipment to maintain its optimal performance.

关 键 词：血液透析设备 计量技术规范 患者安全性 治疗质量 国内外医疗器械标准 设备维护和校准 

分 类 号：R197.39[医药卫生—卫生事业管理]