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
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.
标准预览图
立即下载标准文件