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ANSI/AAMI/ISO 23500-4:2019

Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies

Specifies minimum requirements for concentrates to be used in haemodialysis and related therapies. Addressed to the manufacturer of such concentrates. 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. Gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. Revision of ANSI/AAMI 13958:2014.

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Association for the Advancement of Medical Instrumentation [AAMI]


As the voice of the U.S. standards and conformity assessment system, the American National Standards Institute (ANSI) empowers its members and constituents to strengthen the U.S. marketplace position in the global economy while helping to assure the safety and health of consumers and the protection of the environment.