血液透析和相关治疗用液体的制备和质量管理 第1部分：一般要求

[中文适用范围]： 本文件规定了透析从业人员对血液透析和相关疗法所用液体以及在线疗法（如血液透析滤过和血液滤过）所用替代液的制备的一般要求。本文件为用户在用于制备血液透析和相关疗法的液体的设备交付和安装后对其所承担的责任提供指导。由于用于制备透析液的透析水也可用于再处理未标记为一次性使用的透析器，因此本文件也涵盖了这方面的用水。本文件适用于——用于处理和分配用于制备透析液和替代液的水的设备的质量管理，从市政用水进入透析设施的点到最终透析液进入透析器或注入替代液的点。 — 在透析设施中，用于从粉末或其他高浓度介质制备酸和碳酸氢盐浓缩物的设备的质量管理，以及 — 从透析水和浓缩物制备最终透析液或替代液。本文件不适用于 — 再生和再循环少量透析液的吸附剂透析液再生系统， — 使用预包装溶液的连续肾脏替代疗法系统，以及 — 腹膜透析系统和溶液。本文件不涉及与不当使用此类液体相关的临床问题。 [外文原描述]： This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document. This document is applicable to — the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused. — the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and — the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. This document does not apply to — sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, — systems for continuous renal replacement therapy that use pre-packaged solutions, and — systems and solutions for peritoneal dialysis. This document does not address clinical issues associated with inappropriate usage of such fluids.