Overview

This document specifies the minimum requirements for concentrates used in haemodialysis and related therapies. This document is intended for manufacturers of such concentrates. The dialysis fluid produced by the end user is mentioned in several places in this document in order to clarify the requirements for concentrate production. 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 is applicable to: - concentrates in both liquid and powder forms; - 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; - equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. This document does not apply to: - concentrates prepared from pre-packaged salts and water at a dialysis facility for use in that facility. Although references to dialysis fluids appear in this document, it does not cover dialysis fluids produced by the end user. This document also does not include requirements for the frequency of monitoring water purity for dialysis fluids produced in a dialysis facility. This document does not cover sterile dialysis fluid bags or sorbent-based dialysis fluid reprocessing systems that reprocess and recirculate small amounts of 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 hemodialysis equipment, which is covered by IEC 60601-2-16:2018. The responsible national standardization committee is Working Committee NA 176-04-06 AA "Extrakorporaler Kreislauf, Apparate und Einmalartikel" ("Extracorporeal circuits, equipment and disposables") at DIN Standards Committee Health Technologies (NAGesuTech).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-06 AA - Extracorporeal circuits, equipment and disposables  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 150/SC 2/WG 5 - Renal replacement, detoxification and apheresis