标准编号：ISO 23500-4:2019
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4部分：血液透析和相关治疗用浓缩物
英文名称：Preparation and quality management of fluids for haemodialysis and related therapies — Part 4: Concentrates for haemodialysis and related therapies
发布日期：2019-02
标准范围
This document specifies minimum requirements for concentrates used for haemodialysis and related
therapies.
This document is addressed to the manufacturer of such concentrates. In several instances in this
document, the dialysis fluid is addressed, which is made by the end user, to help clarify the requirements
for manufacturing concentrates. Because the manufacturer of the concentrate does not have control
over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of
the manufacturer.
This document includes concentrates in both liquid and powder forms. It also includes additives, also
called spikes, which are chemicals that can be added to the concentrate to supplement or increase the
concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.
This document also specifies requirements for equipment used to mix acid and bicarbonate powders
into concentrate at the user's facility.
Concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility
are excluded from the scope of this document. Although references to dialysis fluid appear herein,
this document does not address dialysis fluid as made by the end user. This document also excludes
requirements for the surveillance frequency of water purity used for the making of dialysis fluid by the
dialysis facility. This document does not address bags of sterile dialysis fluid or sorbent dialysis fluid
regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid
is covered in ISO 23500-5. The making of dialysis fluid involves the proportioning of concentrate and
water at the bedside or in a central dialysis fluid delivery system. Although the label requirements
for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure
proper use.
This document does not cover haemodialysis equipment, which is addressed in IEC 60601-2-16:2012.
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