ISO 23500-4:2019 血液透析和相关治疗用液体的制备和质量管理 第4部分：血液透析和相关治疗用浓缩物

标准编号：ISO 23500-4:2019

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4部分：血液透析和相关治疗用浓缩物

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：2019-02

标准范围

本文件规定了血液透析和相关治疗用浓缩物的最低要求。本文件寄往此类浓缩物的制造商。在本文件的几个实例中，最终用户生产的透析液有助于澄清浓缩液的生产要求。由于浓缩液制造商对最终透析液没有控制权，因此提及透析液是为了澄清，而不是制造商的要求。本文件包括液体和粉末形式的浓缩物。它还包括添加剂，也称为尖峰，是可以添加到浓缩液中的化学品，以补充或增加浓缩液中以及最终透析液中一种或多种现有离子的浓度。本文件还规定了用户设施中用于将酸和碳酸氢盐粉末混合成浓缩物的设备的要求。在透析设施中使用预包装盐和水制备的浓缩物不在本文件范围内。虽然本文中出现了透析液的参考文献，但本文件不涉及最终用户生产的透析液。本文件还不包括透析设施用于制备透析液的水纯度监测频率的要求。本文件不涉及再生和再循环少量透析液的无菌透析液袋或吸附剂透析液再生系统。本文件不包括用于临床透析患者的透析液。透析液包含在ISO 23500-5中。透析液的配制涉及在床边或中央透析液输送系统中按比例混合浓缩液和水。虽然透析液的标签要求放在浓缩物的标签上，但用户有责任确保正确使用。本文件不包括IEC 60601-2-16:2012中提到的血液透析设备。

This document specifies minimum requirements for concentrates used for haemodialysis and related therapies.This document is addressed to the manufacturer of such concentrates. In several instances in this document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer.This document includes concentrates in both liquid and powder forms. It also includes 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.This document also specifies requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this document. Although references to dialysis fluid appear herein, this document does not address dialysis fluid as made by the end user. This document also excludes requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.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.This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.

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