GB/T 19335标准的更新与对比  

Update and Comparative Analysis of the New and Old Versions of GB/T19335

作　　者：谢妍 胡相华[1] 黄敏菊[1] XIE Yan;HU Xiang-hua;HUANG Min-ju(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《中国医疗器械信息》2023年第17期31-34,共4页China Medical Device Information

基　　金：广东省药品监督管理局科技创新项目(项目名称:ECMO系统中氧合器检验模型及技术研究,项目编号:2022ZDZ05)。

摘　　要：文章通过对GB/T 19335新旧标准的对比分析,发现2022版标准重新梳理了标准结构,调整了原标准技术要求较低或不完善的相关内容,以适应行业发展需要,进一步提高标准的适应性和可操作性。文章有助于检验机构对标准的深入理解,更好地开展检测工作;同时有利于企业更好理解该标准的相关技术规范,生产更为安全可靠的血路产品。Through the comparative analysis of the old and new standards of GB/T 19335,the results shows that the 2022 version of the standard reorganizes the standard structure and adjusts the relevant content with low or imperfect technical requirements of the original standard to meet the needs of industry development and further improve the adaptability and operability of the standard.The article helps the inspection agency to have an in-depth understanding of the standard and better carry out the testing work;At the same time,it is conducive to enterprises to better understand the relevant technical specifications of the standard and produce safer and more reliable blood circuit products.

关 键 词：GB/T19335 标准 比对 

分 类 号：TH789[机械工程—仪器科学与技术]