CAN/CSA-ISO 13958:15
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 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.
OEN:
CSA
Langue:
English
Code(s) de l'ICS:
11.040.40
Statut:
Annulée
Date de Publication:
2015-10-31
Numéro Standard:
CAN/CSA-ISO 13958:15