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ANSI/AAMI/ISO 23500-4:2024
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: 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: concentrates in both liquid and powder forms; additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid; and equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.
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Association for the Advancement of Medical Instrumentation [aami]