BS EN ISO 13958:2015 specifies minimum requirements for concentrates used for haemodialysis and related therapies. For the purpose of this International 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 haemodialysis and related therapies. This International Standard is addressed to the manufacturer of such concentrates. In several instances in this International 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 International 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. This International Standard also gives requirements for equipment used to mix acid and bicarbonate powders into concentrate at the user's facility.

Concentrates prepared from prepackaged salts and water at a dialysis facility for use in that facility are excluded from the scope of this International Standard. Although references to dialysis fluid appear herein, this International Standard does not address dialysis fluid as made by the end user. Also excluded from the scope of this International Standard are requirements for the monitoring frequency of water purity used for the making of dialysis fluid by the dialysis facility. Recommendations from the technical committee responsible for this International Standard for monitoring water quality are contained in ISO 23500. This International Standard does not address bags of sterile dialysis fluid or sorbent dialysis fluid regeneration systems that regenerate and recirculate small volumes of the dialysis fluid.


Cross References:
ISO 11663:2014
EN ISO 11663:2015
ISO 13959:2014
EN ISO 13959:2015
ISO 14971:2007
EN ISO 14971:2012
IEC 60601-1:2005
IEC 60601-1:2005/Corrigendum 1:2006
IEC 60601-1:2005/Corrigendum 2:2007
IEC 60601-1:2005/A1:2012
EN 60601-1:2006
EN 60601-1:2006/Corrigendum 1:2010
EN 60601-1:2006/A1:2013
IEC 61010-1:2010
IEC 61010-1:2010/Corrigendum 1:2011
EN 61010-1:2010
93/42/EEC
ISO 15223-1
ISO 15223:2000/A1:2002
ISO 15223:2000/A2:2004
ISO 23500
IEC 60601-2-16:2012
EPA-600-4-79-020:1979
EPA-600-R-94-111:1994
Safe Drinking Water Act 1996
USP 26-NF 21:2003


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