CSA Z23500-5:20 (R2024)

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CSA Preface This is the first edition of CSA Z23500-5, Preparation and quality management of fluids for haemodialysis and related therapies — Part 5: Quality of dialysis fluid for haemodialysis and related therapies , which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 23500-5 (first edition, 2019-02). It replaces CAN/CSA-ISO 11663:15 (adopted ISO 11663:2014), Quality of dialysis fluid for haemodialysis and related therapies. For brevity, this Standard will be referred to as “CSA Z23500-5” throughout. 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 minimum quality requirements for dialysis fluids used in haemodialysis and related therapies. This document includes dialysis fluids used for haemodialysis and haemodiafiltration, including substitution fluid for haemodiafiltration and haemofiltration. This document excludes the water and concentrates used to prepare dialysis fluid or the equipment used in its preparation. Those areas are covered by other International Standards. Sorbent-based dialysis fluid regeneration systems that regenerate and recirculate small volumes of dialysis fluid, systems for continuous renal replacement therapy that use pre-packaged solutions, and systems and solutions for peritoneal dialysis are excluded from this document.