摘要
通过对GB/T 14233.1新旧标准进行对比分析,发现2022版标准新增了电感耦合等离子体发射光谱法和质谱法等检测方法,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。文章的分析有助于医疗器械检测行业更深入地理解医用输液、输血、注射器具化学分析方法,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医用输液、输血、注射器具。
By comparing and analyzing the new and old versions of GB/T 14233.1, the results show that the 2022 version of the standard adds inductively coupled plasma emission spectrometry and mass spectrometry and other test methods, 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 analysis of this paper helps the medical device testing industry to have a deeper understanding of GB/T 14233.1, and better carry out the detection work. At the same time, it is conducive to enterprises to better understand the relevant technical specifications, and produce safer and more reliable medical infusion, blood transfusion and injection equipment.
作者
钟文倩
黄敏菊
ZHONG Wen-qian;HUANG Min-ju(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangdong Guangzhou 510663)
出处
《中国医疗器械信息》
2023年第1期21-23,69,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:2022ZDZ205)
广东省科技厅项目(项目名称:非脱细胞基质类新型胶原基角膜再生修复材料的个性化仿生构建及临床应用,项目编号:2020B1111150002)。
