血液透析及相关治疗用液体的制备和质量管理

[中文适用范围]： 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， — 基于透析液的血液透析滤过和血液滤过的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液或生产透析液的设备 — 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， — 使用预包装溶液的持续肾脏替代疗法系统，以及 — 腹膜透析系统和溶液。透析液成分的输送和监测及其允许的设定点偏差受 IEC 60601-2-16 中定义的保护系统的管辖。 [外文原描述]： 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.