Update of the ISO 23500 set of standards “Рreparation and quality management of fluids for hemodialysis and related therapy”. Water for hemodialysis

Abstract

The article reviews the updates introduced in the 2024 edition of the ISO 23500 standards (International Organization for Standardization), proving a historical overview of the evolution of this standard series. Originally published in 2019, the ISO 23500 series of standards was officially translated into Russian and approved as GOST R ISO 23500 15-2021.
The supplementary materials outline the requirements for dialysis water set in other regulatory documents, as well as technical specification for water treatment equipment. The article emphasizes that the storage phase of water for hemodialysis (WHD), alongside its production system, plays a critical role in maintaining WHD quality. It presents a detailed list of essential equipment components for dialysis water treatment systems. Additionally, the article discusses the role of medical purpose as a key criterion in classifying water treatment equipment as medical devices (MD). A two-tiered classification approach is proposed. The first type is compact units with easily replaceable consumables that do not require professional maintenance. These are suitable for home use or emergency dialysis situations, providing individual dialysis (considered medical device). The second type – large-scale engineering systems designed to supply more than two patients, ensuring continuous, high-volume delivery of WFD and requiring professional technical maintenance.