血液透析及相关治疗用液体的制备和质量管理

[中文适用范围]： 本文件规定了用于制备透析液、浓缩液和血液透析器再处理的水的最低化学和微生物质量要求，以及确保符合要求的必要步骤。本文件还提供了持续监测此类水的化学和微生物质量纯度的指导。本文件适用于 — 用于制备血液透析、血液透析滤过和血液滤过的透析液和血液透析器再处理的水，以及 — 用于制备浓缩液的水。本文件不适用于透析液再生系统。水处理设备的操作以及将处理过的水与浓缩液最终混合以生产透析液的责任完全由透析专业人员承担。 [外文原描述]： This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality. This document is applicable to — water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and — water used in the preparation of concentrates. This document does not apply to dialysis fluid regenerating systems. The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.