摘要
血液透析是肾衰竭患者维持生命的关键治疗手段,透析用水的质量影响治疗安全性和效果。为保障透析用水符合临床需求,我国于2022年7月1日发布行业标准《血液透析和相关治疗用液体的制备和质量管理 第1部分:血液透析和相关治疗用水处理设备》(YY/T 0793.1-2022),该标准于2024年7月1日正式实施。YY/T 0793.1-2022在国际标准ISO 23500-2:2019 的基础上,结合我国临床、行业、监管及标准体系进行了修订。本文通过对比旧版YY 0793.1-2010/YY 0793.2-2011和YY/T 0793.1-2022 主要技术性差异,对新版标准的关键条款进行解读,旨在为行业理解和贯彻该标准提供参考,推动行业高质量发展,为血液透析用水的安全提供更为可靠的技术支撑。
Abstract
Hemodialysis is a critical life-sustaining therapy for patients with end-stage renal failure. The quality of dialysis water affects treatment safety and efficacy. To ensure the clinical requirements of dialysis water, YY/T 0793.1-2022 was issued on July 1, 2022, and has been implemented since July 1 2024. YY/T 0793.1-2022 is revised based on the international standard ISO 23500-2:2019, incorporating our own clinical practice, industry conditions, regulatory requirements, and national standard system. This paper compares the major technical differences between the older versions YY 0793.1‑2010/YY 0793.2‑2011 and the new version YY/T 0793.1-2022, and interprets the key clauses in the new version, aiming to provide the industry with understanding and implementing the standard, the guidance on high-quality development and reliable technical support for safety of hemodialysis water.
关键词
水处理设备 /
血液透析 /
YY/T 0793.1-2022
Key words
Water treatment equipment /
Hemodialysis /
YY/T 0793.1-2022
吴少海 蔡海青 刘锦焕 黄敏菊 樊 翔.
YY/T 0793.1-2022《血液透析和相关治疗用液体的制备和质量管理 第1部分:血液透析和相关治疗用水处理设备》标准解读[J]. 中国血液净化. 2026, 25(07): 596-600 https://doi.org/10.3969/j.issn.1671-4091.2026.07.011
WU Shao-hai, CAI Hai-qing, LIU Jin-huan, HUANG Min-ju, FAN Xiang.
Interpretation of YY/T 0793.1-2022 “Preparation and quality management of fluids for hemodialysis and related therapies - Part 1: Water treatment equipment for hemodialysis applications and related therapies” [J]. Chinese Journal of Blood Purification. 2026, 25(07): 596-600 https://doi.org/10.3969/j.issn.1671-4091.2026.07.011
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基金
国家重点研发计划项目(2023YFC2411800)