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
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.
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