AAMI RD61:2006

For the purpose of this standard, "concentrates" are a mixture of chemicals and water, or a mixture of chemicals in the form of dry powder, that are delivered to the end user to make dialysate used to perform hemodialysis. This standard is addressed to the manufacturer of such concentrates. The requirements and goals established by this standard will help ensure the effective, safe performance of hemodialysis concentrates and related materials.This standard includes bicarbonate and acid concentrates in both liquid and powder forms. Also included are additives commonly called "spikes", chemicals which 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 dialysate. This standard also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.