输液设备用一次性使用防回流阀的阻断性能测试方法探究  

Blocking performance test method of disposable check valves for infusion equipment

作　　者：党玺芸 徐苏华[1] 白雪 柯军[1] 汤智[1] 冯珊[1] 林铄寒 DANG Xi-yun;XU Su-hua;BAI Xue;KE Jun;TANG Zhi;FENG Shan;LIN Shuo-han(Guangdong Medical Devices Quality Surveillance and Test Insitiute,Guangzhou 510663,China)

机构地区：[1]广东省医疗器械质量监督检验所,广州510663

出　　处：《医疗卫生装备》2024年第9期78-83,共6页Chinese Medical Equipment Journal

基　　金：广东省2023年重点领域研发计划项目(2023 B0101200010);广东省药品监督管理局2023年科技创新项目(2023YDZ08,2023TDB37)。

摘　　要：对比了YY 0585.4—2009和ISO 8536-12:20212个标准中对输液设备用一次性使用防回流阀的阻断性能测试方法,分析了根据YY 0585.4—2009进行防回流阀阻断性能测试时的影响因素和可能存在的操作误区,指出了ISO 8536-12:2021中防回流阀阻断性能的测试方法更加完善合理、科学有效,为标准修订及检测人员的实际操作提供了借鉴和指引。YY 0585.4—2009 and ISO 8536-12:2021 standards were compared in terms of the blocking performance test method of disposable check valves for infusion equipment.The affecting factors and possible errors were analyzed when the blocking performance test was carried out according to YY 0585.4—2009,and it's pointed out ISO 8536-12:2021 gained advantages over YY 0585.4—2009 in the blocking performance test method of check valves.References and guidance were provided for standard revision and actual operation.

关 键 词：输液设备 一次性使用防回流阀 阻断性能 ISO 8536-12:2021 YY 0585.4—2009 

分 类 号：TH77[机械工程—仪器科学与技术]