ISO 23500-3:2019
Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies
This document specifies minimum requirements for water to be used in haemodialysis and related therapies.
This document includes water to be used in the preparation of concentrates, dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
This document excludes the operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid. Those operations are the sole responsibility of dialysis professionals. This document does not apply to dialysis fluid regenerating systems.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Dialysis water quality requirements
4.2 Chemical contaminant requirements
4.2.1 General
4.2.2 Organic Carbon, pesticides and other chemicals
4.3 Dialysis water microbiological requirements
5 Tests for microbiological and chemical requirements
5.1 Dialysis water microbiology
5.2 Microbial contaminant test methods
5.3 Chemical contaminants test methods
Annex A (informative) Rationale for the development and provisions of this document
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Dialysis water quality requirements
4.2 Chemical contaminant requirements
4.2.1 General
4.2.2 Organic Carbon, pesticides and other chemicals
4.3 Dialysis water microbiological requirements
5 Tests for microbiological and chemical requirements
5.1 Dialysis water microbiology
5.2 Microbial contaminant test methods
5.3 Chemical contaminants test methods
Annex A (informative) Rationale for the development and provisions of this document
Bibliography