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BS EN ISO 23500-4:2019

Current
Current

The latest, up-to-date edition.

Preparation and quality management of fluids for haemodialysis and related therapies Concentrates for haemodialysis and related therapies
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

27-03-2019

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 ISO23500‑5. 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 IEC60601‑2‑16:2012.

Committee
CH/150/2
DocumentType
Standard
ISBN
9780580897542
Pages
30
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
ISO 23500-4:2019 Identical
EN ISO 23500-4:2019 Identical

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