CSA序言这是CAN/CSA-Z23500《血液透析和相关治疗用液体的制备和质量管理指南》的第二版，该指南已被采纳，加拿大偏离了同名的ISO（国际标准化组织）标准23500（第二版，2014-04-01）。它取代了2012年发布的前一版CAN/CSA-Z23500（采用ISO 23500:2011）。范围1。1概述本国际标准为透析从业者提供了血液透析和相关治疗用透析液的制备指南，以及在线治疗中使用的替代液，如血液透析滤过和血液滤过。因此，本国际标准是一种推荐做法。1.2本国际标准规定了一旦用于制备透析液的设备交付和安装后，用户对透析液的责任。 就本国际标准而言，透析液包括用于制备透析液和替代液的透析水（定义见3.18），用于在用户设施制备浓缩液的透析水，以及浓缩液和最终透析液和替代液。本国际标准的范围包括a）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，从市政水进入透析设施的点到最终透析液进入透析器的点或注入替代液的点b）用于从透析设施的粉末或其他高浓度介质中制备浓缩液的设备，c）从透析水和浓缩液中制备最终透析液或替代液。 注:由于用于制备透析液的水通常使用与再处理透析器所用的水相同的设备制备和分配，因此再处理透析器所用的水也包含在本国际标准中。1.3例外情况本国际标准不适用于再生和再循环少量透析液的基于吸附剂的透析液再生系统、使用预包装溶液的连续肾脏替代治疗系统以及腹膜透析系统和溶液。

CSA PrefaceThis is the second edition of CAN/CSA-Z23500, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies, which is an adoption, with Canadian deviations of the identically titled ISO (International Organization for Standardization) Standard 23500 (second edition, 2014-04-01). It supersedes the previous edition published in 2012 as CAN/CSA-Z23500 (adopted ISO 23500:2011).Scope1.1 General This International Standard provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, this International Standard functions as a recommended practice. 1.2 Inclusions This International Standard addresses the user's responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of this International Standard, the dialysis fluid includes dialysis water (see 3.18 for definition) used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user-s facility, as well as concentrates and the final dialysis fluid and substitution fluid. The scope of this International Standard includes a) 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 b) equipment used to prepare concentrate from powder or other highly concentrated media at a dialysis facility, and c) preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. NOTE Because water used to prepare dialysis fluid is commonly prepared and distributed using the same equipment as the water used to reprocess dialysers, water used to reprocess dialysers is also covered by this International Standard. 1.3 Exclusions This International Standard 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 prepackaged solutions, and systems and solutions for peritoneal dialysis.