ANSI/AAMI 13958:2014

Concentrates for hemodialysis and related therapies

Specifies minimum requirements for concentrates used for hemodialysis and related therapies. For the purpose of this Standard, “concentrates” are a mixture of chemicals and water, or chemicals in the form of dry powder or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform hemodialysis and related therapies. This Standard is addressed to the manufacturer of such concentrates. In several instances in this Standard, it became necessary to address the dialysis fluid, which is made by the end user, to help clarify the requirements for manufacturing concentrates. Because the manufacturer of the concentrate does not have control over the final dialysis fluid, any reference to dialysis fluid is for clarification and is not a requirement of the manufacturer. This Standard includes concentrates in both liquid and powder forms. Also included are additives, also called spikes, which are chemicals that may be added to the concentrate to increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid.

Association for the Advancement of Medical Instrumentation [aami]

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