ISO 23500-2:2019 血液透析和相关治疗用液体的制备和质量管理 第2部分：血液透析应用和相关治疗用水处理设备

标准编号：ISO 23500-2:2019

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2部分：血液透析应用和相关治疗用水处理设备

英文名称：Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies

发布日期：2019-02

标准范围

1.1概述:本文件适用于水处理系统和/或设备的制造商和/或供应商，用于明确提供血液透析或相关治疗用水。1.2本文件涵盖用于处理血液透析和相关治疗中使用的饮用水的装置，包括用于以下目的的水:a） 在透析设施中从粉末或其他高浓度介质中制备浓缩物；b） 透析液的制备，包括可用于制备替代液的透析液；c） 在允许多次使用的情况下，对一次性使用的透析器进行再处理，d） 未明确标记为一次性使用的透析器的再处理。本文件包括饮用水输送至水处理系统和透析水使用点之间的所有装置、管道和配件。这些设备包括净水设备、在线水质监测器（如电导率监测器）和分配透析水的管道系统。1.3例外情况本文件不包括按比例分配水和浓缩液以生产透析液的透析液供应系统、再生和再循环少量透析液的吸附剂透析液再生系统、透析浓缩液、血液透析过滤系统、血液过滤系统、处理多用途透析器的系统，以及腹膜透析系统。其中一些设备，如透析液输送系统和浓缩液，在ISO 23500-4和ISO 23500-5等其他文件中有介绍，本文件还不包括ISO 23500？1中所述的透析液、浓缩液制备或透析器再处理用水纯度的持续监督。

1.1 General This document is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.1.2 Inclusions This document covers devices used to treat potable water intended for use in the delivery of haemodialysis and related therapies, including water used for:a) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility;b) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid;c) the reprocessing of dialysers intended for single use where permitted for multiple uses,d) the reprocessing of dialysers not specifically marked as intended for single use.This document includes all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of the devices are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for the distribution of dialysis water.1.3 Exclusions This document excludes dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are addressed in other documents such as ISO 23500-4 and ISO 23500？5,This document also excludes the on-going surveillance of the purity of water used for dialysis fluid, concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500？1.

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