CAN/CSA-ISO 13958-11
1 Scope
1.1 General
This International Standard 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 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
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.
1.2 Inclusions
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.
1.3 Exclusions
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.
OEN:
CSA
Langue:
English
Code(s) de l'ICS:
11.040.40
Statut:
Annulée
Date de Publication:
2011-02-28
Numéro Standard:
CAN/CSA-ISO 13958-11