摘要
ISO 23500系列标准规定了血液透析及相关治疗用液体的制备及质量管理,该系列标准体现了国际血液透析医疗专家和生产企业的智慧结晶。本文梳理了血液透析浓缩物国际标准的发展沿革和变迁,阐述了ISO 23500⁃4:2019相对于前版标准ISO 13958:2014的更新,并分析其更新原因。为更好地理解和应用该标准,本文重点介绍了在2021年国内透析浓缩物标准的修订过程中,对ISO 23500⁃4:2019技术内容的运用及转化,变化的重点内容包括性状、微生物限度、细菌内毒素、装量、微粒及溶质浓度,国内标准还增加了枸橼酸根、碳酸氢根的具体检测方法。除此以外,本文还对ISO 23500⁃4需要更新的内容提出建议,对需要优化的检测方法进行初探,以期为血液透析医疗器械的检验检测及未来ISO 23500⁃4的修订工作提供参考。
The ISO 23500 series of standards stipulate the preparation and quality management of hemodialysis and related therapeutic liquids.This series of standards embodies the wisdom of international hemodialysis medical experts and manufacturers.This article sorts out the development and changes of international standards for hemodialysis concentrates,expounds the update of ISO 23500⁃4:2019 relative to the previous version of standard ISO 13958:2014,and analyzes the reasons for the update.In order to better understand and apply this standard,this article focuses on the application and transformation of the technical content of ISO 23500⁃4:2019 during the revision process of the domestic dialysis concentrate standard in 2021.The key changes include traits,microbial limits,bacterial endotoxin,loading capacity,particulate and solute concentrations,and specific detection methods for citrate and bicarbonate have also been added to domestic standards.In addition,this paper also puts forward suggestions on the content that needs to be updated in ISO 23500⁃4,and conducts a preliminary study on the testing methods that need to be optimized,in order to provide reference for the inspection and testing of hemodialysis medical devices and the revision of ISO 23500⁃4 in the future.
作者
叶晓燕
黄麒谕
吴静标
卢润潮
邹米莎
YE Xiaoyan;HUANG Qiyu;WU Jingbiao;LU Runchao;ZOU Misha(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou,Guangdong,China,510663;Fresenius Medical Care R&D(Shanghai)Co.,Ltd.,Shanghai,China,200233)
出处
《分子诊断与治疗杂志》
2022年第12期2023-2026,共4页
Journal of Molecular Diagnostics and Therapy
基金
广东省药品监督管理局科技创新项目(2018ZDZ04)。
