摘要
YY 0793.2-2023《血液透析和相关治疗用液体的制备和质量管理第2部分:血液透析和相关治疗用水》已于2023年11月22日发布,将于2026年12月1日开始实施.本文将YY 0793.2-2023与YY 0572-2015、ISO 23500-3:2019进行对比,并对部分重要条款的差异进行解读,包括标准适用范围、质量要求、微生物要求和检测方法、化学污染物要求和检测方法,最终帮助相关企业理解运用该标准.
Abstract
The standard YY 0793.2-2023"Preparation and Quality Management of Fluids for Hemodi-alysis and Related Therapies;part 2:Water for Hemodialysis and Related Therapies"was released on Novem-ber 22,2023,and will be implemented from December 1,2026.This article compares this standard with the standards YY 0572-2015 and ISO 23500-3:2019,and interprets the differences in several important clauses,in-cluding the scope of application,quality requirements,microbiological requirements and their detection meth-ods,chemical pollutants requirements and their detection methods.Ultimately,it will help relevant enterprises understand and apply this standard.
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