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Preparation and quality management of fluids for haemodialysis and related therapies -- Concentrates for haemodialysis and related therapies
This document specifies the chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates.
This document is applicable to:
This document does not apply to:
This document does not cover the dialysis fluid that is used to clinically dialyse patients. Dialysis fluid is covered in ISO 23500-5.
The making of dialysis fluid involves the proportioning of concentrate and water at the bedside or in a central dialysis fluid delivery system. Although the label requirements for dialysis fluid are placed on the labelling of the concentrate, it is the user's responsibility to ensure proper use.
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