GB/T 14233.1《医用输液、输血、注射器具检验方法第1部分:化学分析方法》新旧标准的对比分析  

Comparison between the New and Old Versions of GB/T 14233.1,Test methods of infusion,transfusion,injection equipment for medical use–Part 1:Chemical analysis methods

作　　者：赵微 热孜宛古丽·伊敏 古丽巴哈尔·托乎提 ZHAO Wei;REZIWANGULI·Yimin;GULIBAHAER·Tuohuti(Medical Device Testing Laboratory,Xinjiang Uygur Autonomous Region for Food and Drug Inspection Institute)

机构地区：[1]新疆维吾尔自治区药品检验研究院医疗器械检验研究室

出　　处：《中国标准化》2023年第7期161-164,共4页China Standardization

摘　　要：本文对GB/T 14233.1-2022《医用输液、输血、注射器具检验方法第1部分:化学分析方法》进行解读,并与GB/T 14233.1-2008《医用输液、输血、注射器具检验方法第1部分:化学分析方法》的适用范围、规范性引用文件、术语和定义、通则及化学分析方法等进行了对比,分析了新旧两标准的主要差异,强调提高医疗器械化学性能安全性的重要性,为国内相关检测机构和生产销售企业提供新的技术指导和方法参考,为其正确理解和运用标准、准确判断产品质量提供帮助和指导。This paper interprets GB/T 14233.1-2022,Test Methods of infusion,transfusion,injection equipment for medical use–Part 1:Chemical analysis methods,and compares it with the 2008 version in terms of application,normative reference documents,terms and defi nitions,general rules,chemical analysis methods,etc.It analyzes the main differences between the new and old versions,and emphasizes the importance of improving the safety of chemical performance of medical devices,to provide technical guidance and method reference for domestic relevant testing institutions and production and sales enterprises,and help them correctly understand and use standards and accurately judge product quality.

关 键 词：标准 方法 差异 新增 修改 

分 类 号：TH77[机械工程—仪器科学与技术]