CSA Z23500-2:26

CSA Preface This is the second edition of CSA Z23500-2, Preparation and quality management of fluids for haemodialysis and related therapies — Part 2: Water treatment equipment for haemodialysis applications and related therapies , which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 23500-2 (second edition, 2024-07). It supersedes the previous edition, published in 2020 as CSA Z23500-2 (adopted ISO 23500-2:2019). For brevity, this Standard will be referred to as "CSA Z23500-2" 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 requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies. This document is applicable to all devices, piping and fittings between the point at which water is delivered to the water purification system and the point of use of the purified water. Such components include but are not necessarily limited to water purification devices, online water quality monitors (such as conductivity monitors) and piping systems for the distribution of purified water. This document does not apply to — equipment used in the preparation of concentrates from powder or other highly concentrated media at a dialysis facility either for a single patient or multiple patients, — dialysis fluid supply systems that proportion water and concentrates to produce dialysis fluid, — sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid, — dialysis concentrates, — haemodiafiltration or haemofiltration systems, — systems that process dialysers for multiple uses, and — peritoneal dialysis systems. Requirements for the ongoing monitoring of water purity in terms of chemical and microbiological quality are given in ISO 23500-3.