ISO 23500-5:2024 血液透析及相关治疗用液体的制备和质量管理 第5部分：血液透析及相关治疗用透析液的质量

标准编号：ISO 23500-5:2024

中文名称：血液透析及相关治疗用液体的制备和质量管理 第5部分：血液透析及相关治疗用透析液的质量

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：2024-04

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化学和微生物质量要求。本文件适用于-用于血液透析和血液透析滤过的透析液，-用于血液透析滤过和基于透析液的血液滤过在线生产的替代液本文件不适用于-用于制备透析液的水和浓缩物或用于生产透析液的设备-再生和再循环小体积透析流体的基于吸附剂的透析流体再生系统，-使用预包装溶液的连续肾脏替代治疗系统，以及-用于腹膜透析的系统和解决方案。透析液组合物的输送和监测及其与设定点的允许偏差由IEC 60601-2-16中定义的保护系统控制。

This document specifies the minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies.

This document applies to

—     dialysis fluids used for haemodialysis and haemodiafiltration,

—     substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid

This document does not apply to

—     the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid

—     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.

The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.

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