CSA Z23500-5:26

CSA Preface This is the second 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 (second edition, 2024-04). It supersedes the previous edition, published in 2020 as CSA Z23500-5 (adopted ISO 23500-5:2019). For brevity, this Standard will be referred to as "CSA Z23500-5" 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 dialysis fluids used in haemodialysis and related therapies. This document applies to — dialysis fluids used for haemodialysis and haemodiafiltration, — substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid This document does not apply to — the water and concentrates used to prepare dialysis fluid or the equipment to produce dialysis fluid — 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. The delivery and monitoring of the dialysis fluid composition and its permitted deviation from set points is governed by protective systems defined in IEC 60601-2-16.