ISO 23500-5:2019 血液透析和相关治疗用液体的制备和质量管理 第5部分：血液透析透析液质量及相关治疗

标准编号：ISO 23500-5:2019

中文名称：血液透析和相关治疗用液体的制备和质量管理 第5部分：血液透析透析液质量及相关治疗

英文名称：Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies

发布日期：2019-02

标准范围

本文件规定了血液透析和相关治疗中使用的透析液的最低质量要求。本文件包括用于血液透析和血液透析滤过的透析液，包括血液透析滤过和血液滤过的替代液。本文件不包括用于制备透析液的水和浓缩液，或用于制备透析液的设备。其他国际标准也涵盖了这些领域。基于吸附剂的透析液再生系统，用于再生和再循环少量透析液，用于连续性肾脏替代治疗的系统，使用-本文件不包括包装溶液、腹膜透析系统和溶液。

This document specifies minimum quality requirements for dialysis fluids used in haemodialysis and related therapies.This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration.This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards.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 are excluded from this document.

标准预览图