ISO 23500:2011 血液透析及相关治疗用液体的制备和质量管理指南

标准编号：ISO 23500:2011

中文名称：血液透析及相关治疗用液体的制备和质量管理指南

英文名称：Guidance for the preparation and quality management of fluids for haemodialysis and related therapies

发布日期：2011-05

标准范围

ISO 23500:2011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，ISO 23500:2011是一种推荐做法。ISO 23500:2011规定，一旦用于透析液制备的设备交付并安装完毕，用户应对透析液负责。就ISO 23500:2011而言，透析液包括用于制备透析液和替代液的水、用于在用户设施制备浓缩液的水，以及浓缩液和最终透析液和替代液。ISO 23500:2011的范围不包括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。

ISO 23500:2011 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, ISO 23500:2011 functions as a recommended practice.ISO 23500:2011 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 ISO 23500:2011, the dialysis fluid includes water used for the preparation of dialysis fluid and substitution fluid, water used for the preparation of concentrates at the user's facility, as well as concentrates and the final dialysis fluid and substitution fluid.Excluded from the scope of ISO 23500:2011 are 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.

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