CSA Z23500-3:26

CSA Preface This is the second edition of CSA Z23500-3, Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies , which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 23500-3 (second edition, 2024-04). It supersedes the previous edition, published in 2020 as CSA Z23500-3 (adopted ISO 23500-3:2019). For brevity, this Standard will be referred to as "CSA Z23500-3" throughout. CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon, as administered by Canada’s Drug Agency (CDA-AMC). This Standard was reviewed for Canadian adoption by the CSA Subcommittee on Quality Management for Kidney Dialysis, under the jurisdiction of the CSA Technical Committee on Kidney Dialysis and the CSA Strategic Steering Committee on Health and Well-being, and has been formally approved by the Technical Committee. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. The document also provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality. This document is applicable to — water used in the preparation of dialysis fluids for haemodialysis, haemodiafiltration and haemofiltration and the reprocessing of haemodialysers, and — water used in the preparation of concentrates. This document does not apply to dialysis fluid regenerating systems. The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are the sole responsibility of dialysis professionals.