本文件规定了用于血液透析和相关治疗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过滤的透析液，包括血液透析过滤和血液过滤的替代液。 本文件不包括用于制备透析液的水和浓缩液或用于制备的设备。其他国际标准涵盖了这些领域。 本文件不包括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、使用预包装溶液的连续肾脏替代治疗系统以及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.