ISO 23500-3:2024 血液透析及相关治疗用液体的制备和质量管理 第3部分：血液透析及相关治疗用水

标准编号：ISO 23500-3:2024

中文名称：血液透析及相关治疗用液体的制备和质量管理 第3部分：血液透析及相关治疗用水

英文名称：Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies

发布日期：2024-04

标准范围

本文件规定了用于制备透析液、浓缩液和血液透析器再处理的水的最低化学和微生物质量要求，以及确保符合要求的必要步骤。该文件还为持续监测此类水的化学和微生物质量纯度提供了指导。本文件适用于-用于制备血液透析、血液透析滤过和血液滤过的透析液以及血液透析器的再处理的水，以及-用于制备浓缩物的水。本文件不适用于透析液再生系统。水处理设备的操作以及处理后的水与浓缩物的最终混合以产生透析液是透析专业人员的唯一责任。

This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality.

This document is applicable to

—     water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and

—     water used in the preparation of concentrates.

This document does not apply to dialysis fluid regenerating systems.

The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.

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