血液透析及相关疗法的液体准备与质量管理 第2部分：血液透析应用及相关疗法的水处理设备（ISO 23500-2:2024）

[中文适用范围]： 本文件规定了单一水处理设备和由一个或多个此类设备组成的水处理系统的具体要求与推荐事项。该文件面向指定完整水处理系统的人或公司，以及组装并安装此系统的供应商。由于系统可以由多种单个水处理设备组成，因此本文件的规定也适用于这些设备的制造商，前提是制造商表明该装置旨在用于供应用于血液透析及相关疗法的用水。本文件适用于所有从向水净化系统供水的点到纯净水使用点之间的设备、管道和配件。此类组件包括但不限于水净化设备、在线水质监测仪（如电导率监测仪）以及纯净水分配系统的管道系统。本文件不适用以下情况——用于透析设施制备粉末或其他高浓缩介质浓缩液的设备，无论是为单个患者还是多个患者使用；——用于按比例混合水和浓缩液以产生透析液的透析液体供应系统；——再生并循环小体积透析液的吸附型透析液再生系统；——透析浓缩液；——血液透滤或血滤系统；——多用途透析器处理系统；——腹膜透析系统。有关化学和微生物质量持续监测的要求见ISO 23500-3。 [外文原描述]： This document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies. This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water. This document does not apply to — equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients, — 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 or haemofiltration systems, — systems that process dialysers for multiple uses, and — peritoneal dialysis systems. Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3.