ISO 23500-1:2024 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 23500-1:2024

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：2024-08

标准范围

本文件规定了透析从业人员制备血液透析和相关治疗用液体以及在线治疗（如血液透析滤过和血液滤过）中使用的替代液体的一般要求。一旦用于血液透析和相关治疗的设备交付和安装，本文件就用户对血液透析和相关治疗中使用的液体的责任提供了指导。由于用于制备透析液的透析水也可用于再处理未标记为单次使用的透析器，因此本文件也涵盖了水使用的这一方面。本文件适用于-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。-在透析设施中用于从粉末或其他高浓度介质制备酸和碳酸氢盐浓缩物的设备的质量管理，以及-由透析水和浓缩物制备最终透析流体或替代流体。本文件不适用于-再生和再循环小体积透析流体的基于吸附剂的透析流体再生系统，-使用预包装溶液的连续肾脏替代治疗系统，以及-用于腹膜透析的系统和解决方案。本文件不涉及与此类液体不当使用相关的临床问题。

This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis 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.

This document is applicable to

—     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.

—     the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and

—     the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates.

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.

This document does not address clinical issues associated with inappropriate usage of such fluids.

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