ANSI/AAMI/ISO 13958:2009
Concentrates for hemodialysis and related therapies

Standard No.
ANSI/AAMI/ISO 13958:2009
Release Date
2009
Published By
American National Standards Institute (ANSI)
Latest
ANSI/AAMI/ISO 13958:2009
Scope
Specifies minimum requirements for concentrates used for haemodialysis and related therapies. 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 or other highly concentrated media, that are delivered to the end user to make dialysis fluid used to perform haemodialysis and related therapies. This standard is addressed to the manufacturer of such concentrates. Includes concentrates in both liquid and powder forms. Also included are additives also called spikes. Gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.

ANSI/AAMI/ISO 13958:2009 history




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