General This International Standard is intended for manufacturers and/or suppliers of water treatment systems and/or devices for the express purpose of providing water for hemodialysis and related therapies. Inclusions This International Standard covers equipment for the preparation of water for hemodialysis and related therapies, including water for: (1) the production of concentrates from powder or other highly concentrated media in a dialysis facility; (2) the production of dialysis fluid, including dialysis fluid that can be used to produce replacement fluid; (3) the reprocessing of multi-purpose dialyzers. The scope of this International Standard includes all equipment, lines/pipes and fittings between the point at which drinking water is supplied to the water treatment system and the point of use of the dialysis water. Examples of devices within the scope of this International Standard include water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for dialysis water distribution. Exclusions Excluded from the scope of this International Standard are dialysis fluid delivery systems that meter water and concentrates for the production of dialysis fluid, sorbent-based dialysis fluid reprocessing systems in which small volumes of dialysis fluid are reprocessed and recirculated, dialysis concentrates, hemodiafiltration systems, hemofiltration systems, systems for Reprocessing of multi-purpose dialyzers and peritoneal dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are covered by other International Standards. Also excluded from the scope of this International Standard are requirements for ongoing monitoring of the purity of water for dialysis fluids, the production of concentrates or the reprocessing of dialyzers.
EN ISO 26722:2015 Referenced Document
ASTM F838-05 Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration*， 2024-04-20 Update
IEC 60601-1-8:2006 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ISO 11663:2014 Quality of dialysis fluid for haemodialysis and related therapies
ISO 13959:2014 Water for haemodialysis and related therapies
ISO 14971:2007 Medical devices - Application of risk management to medical devices
ISO 23500:2014 Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
JIS K 3823:2012 Testing methods for determining bacterial rejection of ultrafiltration modules
JIS K 3824:2012 Testing methods for determining endotoxin rejection of ultrafiltration modules
EN ISO 26722:2015 history
2015EN ISO 26722:2015 Water treatment equipment for haemodialysis applications and related therapies