BS EN ISO 23500-4:2019
$142.49
Preparation and quality management of fluids for haemodialysis and related therapies – Concentrates for haemodialysis and related therapies
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 32 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | undefined |
| 4 | European foreword Endorsement notice |
| 7 | Foreword |
| 8 | Introduction |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions 4 Requirements 4.1 Concentrates 4.1.1 Physical state |
| 11 | 4.1.2 Water 4.1.3 Bacteriology of concentrates 4.1.4 Endotoxin levels 4.1.5 Fill quantity 4.1.6 Chemical grade |
| 12 | 4.1.7 Particulates 4.1.8 Additives — “Spikes” 4.1.9 Containers 4.1.10 Bulk-delivered concentrate 4.1.11 Concentrate generators 4.2 Manufacturing equipment 4.3 Systems for bulk mixing concentrate at a dialysis facility 4.3.1 General |
| 13 | 4.3.2 Materials compatibility 4.3.3 Disinfection protection 4.3.4 Safety requirements 4.3.5 Bulk storage tanks |
| 14 | 4.3.6 Ultraviolet irradiators 4.3.7 Piping systems 4.3.8 Electrical safety requirements 5 Tests 5.1 General 5.2 Concentrates 5.2.1 Physical state |
| 15 | 5.2.2 Solute concentrations 5.2.3 Water 5.2.4 Microbial contaminant test methods for bicarbonate concentrates |
| 16 | 5.2.5 Endotoxin levels 5.2.6 Fill quantity 5.2.7 Chemical grade 5.2.8 Particulates |
| 17 | 5.2.9 Additives — “Spikes” 5.2.10 Containers 5.2.11 Bulk delivered concentrate 5.2.12 Concentrate generators 5.3 Manufacturing equipment 5.4 Systems for mixing concentrate at a dialysis facility 5.4.1 General 5.4.2 Materials compatibility 5.4.3 Disinfection protection |
| 18 | 5.4.4 Safety requirements 5.4.5 Bulk storage tanks 5.4.6 Ultraviolet irradiators 5.4.7 Piping systems 5.4.8 Electrical safety requirements 6 Labelling 6.1 General |
| 19 | 6.2 General labelling requirements for concentrates |
| 20 | 6.3 Labelling requirements for liquid concentrate 6.4 Labelling requirements for powder concentrate |
| 21 | 6.5 Additives 6.6 Labelling requirements for concentrate generators |
| 22 | 6.7 Labelling for concentrate mixer systems 6.7.1 General 6.7.2 Product literature for concentrate mixers |
| 24 | Annex A (informative) Rationale for the development and provisions of this document |
| 30 | Bibliography |
