CSA Z23500-1:26

CSA Preface This is the second edition of CSA Z23500-1, Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements , which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 23500-1 (second edition, 2024-08). It supersedes the previous edition, published in 2020 as CSA Z23500-1 (adopted ISO 23500-1:2019). For brevity, this Standard will be referred to as "CSA Z23500-1" 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 general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. This document gives guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. As dialysis water used to prepare dialysis fluid can also be used to reprocess dialysers not marked intended for single use, this aspect of water use is also covered by this document. This document is applicable to — the quality management of equipment used to treat and distribute water used for the preparation of dialysis fluid and substitution fluid, from the point at which municipal water enters the dialysis facility to the point at which the final dialysis fluid enters the dialyser or the point at which substitution fluid is infused. — the quality management of the equipment used to prepare acid and bicarbonate concentrate from powdered or other highly concentrated media at a dialysis facility, and — the preparation of the final dialysis fluid or substitution fluid from dialysis water and concentrates. This document does not apply to — 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. This document does not address clinical issues associated with inappropriate usage of such fluids.