CSA Z23500-4:2020 pdf download.Preparation and quality management of fluids for haemodialysis and related therapies
1 Scope
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.All electrolytes identified on the label shall be present within±5 % or±0,1 mEq/l (expressed as dialysis fluid concentrations), whichever is greater, of the stated concentration, with the exception of sodium, which shall be present within±2,5 % of the labelled concentration or shall be present according to approved specifications by the local regulations. If used, glucose shall be present within±5 % or±0,05 g/l (when measured as properly diluted dialysis fluid), whichever is greater, of the labelled concentration, or shall be present according to approved specifications by the local regulations. Where concentrates include non-traditional constituents, such as antioxidants and iron compounds, these constituents shall be present at nominal concentrations with±5 % tolerances or shall be present according to approved specifications by the local regulations. If alternate, locally approved tolerances are used, the tolerances shall be similarly stated and the rationale for their use documented. CSA Z23500-4 pdf download.