ISO 23500-1:2019 血液透析和相关治疗用液体的制备和质量管理 第1部分：一般要求

标准编号：ISO 23500-1:2019

中文名称：血液透析和相关治疗用液体的制备和质量管理 第1部分：一般要求

英文名称：Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements

发布日期：2019-02

标准范围

1.1概述本文件是涉及水处理设备、水、透析水、浓缩液和透析液（ISO 23500系列）的许多其他标准的基础标准，并为透析从业者提供血液透析和相关治疗用透析液以及在线治疗用替代液的制备指南，例如血液透析滤过和血液滤过。因此，本文件作为推荐做法发挥作用。本文件不涉及可能与不当使用水、透析水、浓缩液或透析液有关的临床问题。参与肾衰竭治疗的医疗专业人员应就使用这些液体的应用做出最终决定，例如血液透析、血液透析滤过、高通量血液透析和透析器的再处理，并且需要意识到在每种治疗中使用不适当的液体质量会引发的问题。本文件中包含的概念不应被视为不灵活或静态的。应定期审查此处提出的建议，以吸收对透析液纯度在患者预后和技术发展中作用的更多理解。1.2本文件阐述了一旦用于透析液制备的设备交付并安装后，用户对透析液的责任。就本文件而言，透析液包括:a） 用于制备透析液和替代液的透析水（定义见3.17），b） 用于在用户设施制备浓缩物的透析水，c） 浓缩物，d） 最终透析液和替代液。本文件的范围包括a） 用于处理和分配用于制备透析液和替代液的水的设备的质量管理，从市政水进入透析设施的点到最终透析液进入透析器的点或注入替代液的点，b） 用于在透析设施中从粉末或其他高浓度介质中制备浓缩物的设备，以及c） 从透析水和浓缩液中制备最终透析液或替代液。注:由于用于制备透析液的水也可用于重新处理未标记为一次性使用的透析器，因此本文件也涵盖了这方面的用水。1.3除外条款本文件不适用于再生和再循环少量透析液的基于吸附剂的透析液再生系统、使用预包装溶液的连续肾脏替代治疗系统以及腹膜透析系统和溶液。

1.1 General This document is the base standard for a number of other standards dealing with water treatment equipment, water, dialysis water, concentrates, and dialysis fluid (ISO 23500 series) and provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this document functions as a recommended practice.This document does not address clinical issues that might be associated with inappropriate usage of the water, dialysis water, concentrates, or dialysis fluid. Healthcare professionals involved in the provision of treatment for kidney failure should make the final decision regarding the applications with which these fluids are used, for example, haemodialysis, haemodiafiltration, high-flux haemodialysis, and the reprocessing of dialysers, and need to be aware of the issues that the use of inappropriate fluid quality raises in each of the therapies.The concepts incorporated in this document should not be considered inflexible or static. The recommendations presented here should be reviewed periodically in order to assimilate increased understanding of the role of dialysis fluid purity in patient outcomes and technological developments.1.2 Inclusions This document addresses the user's responsibility for dialysis fluid once the equipment used in its preparation has been delivered and installed.For the purposes of this document, dialysis fluid includes:a) dialysis water (see 3.17 for definition) used for the preparation of dialysis fluid and substitution fluid,b) dialysis water used for the preparation of concentrates at the user's facility,c) concentrates,d) the final dialysis fluid and substitution fluid.The scope of this document includesa) the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused,b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, andc) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.NOTE Because water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document.1.3 Exclusions This document does not apply to sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis.

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