ISO 23500-4:2024 血液透析及相关治疗用液体的制备和质量管理 第4部分：血液透析及相关治疗用浓缩物

标准编号：ISO 23500-4:2024

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4部分：血液透析及相关治疗用浓缩物

英文名称：Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies

发布日期：2024-04

标准范围

本文件规定了用于血液透析和相关治疗的浓缩液的化学和微生物学要求，并适用于此类浓缩液的制造商。本文件适用于:-液体和粉末形式的浓缩物；-添加剂，也称为尖峰，其是可以添加到浓缩物中以补充或增加浓缩物中并因此在最终透析流体中的一种或多种现有离子的浓度的化学品；-用于在用户设施中将酸和碳酸氢盐粉末混合成浓缩物的设备。本文件不适用于:-在透析设施中由预包装的盐和水制备的浓缩物，用于该设施；-预包装的无菌透析液；-吸附剂透析流体再生系统，其再生和再循环小体积的透析流体；-进行患者治疗的设备；这在IEC 60601-2-16中得到了解决。本文件不涵盖用于临床透析患者的透析液。ISO 23500-5涵盖了透析液。透析液的制备涉及在床边或在中央透析液输送系统中对浓缩物和水进行配比。尽管透析液的标签要求放在浓缩液的标签上，但用户有责任确保正确使用。

This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.

This document is applicable to:

—     concentrates in both liquid and powder forms;

—     additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid;

—     equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.

This document does not apply to:

—     concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility;

—     pre-packaged and sterile dialysis fluid;

—     sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid;

—     equipment to perform patient treatment; this is addressed IEC 60601-2-16.

This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.

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