This international standard specifies the minimum requirements for water to be used in hemodialysis and related treatments. Specifies the minimum requirements for water to be used in the preparation of concentrates, dialysis fluids for hemodialysis, hemodiafiltration and hemofiltration, and for reprocessing hemodialyzers.
Operation of water treatment equipment and final mixing of purified water with concentrates to produce dialysis fluid are outside of this international standard. These operations are solely the responsibility of dialysis specialists. This international standard does not apply to dialysis fluid regeneration systems.
The dialysis fluid entering the dialyzer is called “fresh dialysis fluid” and the fluid leaving the dialyzer is called “used dialysis fluid”. Throughout this International Standard, the term dialysis fluid means fluid made from dialysis water and concentrates delivered to the dialyzer by the dialysis fluid delivery system. In some countries, terms such as “dialysate” or “dialysis solution” are used instead of dialysis fluid; however, this use is not recommended to avoid confusion.
Manufacturers include, but are not limited to, those performing contract sterilization, installation, relabeling, remanufacturing, repackaging, or specification development functions, and initial distributions to foreign organizations performing these functions. This term does not cover the preparation of concentrates from prepackaged dry chemicals in a dialysis facility or the processing of bulk concentrates in a dialysis facility after responsibility for the concentrate has been transferred from the manufacturer to the user.
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