ISO 13958:2002
(Main)Concentrates for haemodialysis and related therapies
Concentrates for haemodialysis and related therapies
This International Standard is applicable to dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or haemodiafiltration. It addresses chemical quality and purity, microbial contamination, handling, measurement and labelling of concentrates, the requirements for containers and the tests to monitor concentrates. This International Standard does not address the final mixing and use of these concentrates and treated water in such therapies. That operation is the sole responsibility of dialysis professionals. This International Standard is not applicable to dialysing-fluid regeneration systems.
Concentrés pour hémodialyse et thérapies apparentées
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 13958
First edition
2002-09-01
Concentrates for haemodialysis and related
therapies
Concentrés pour hémodialyse et thérapies apparentées
Reference number
ISO 13958:2002(E)
© ISO 2002
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ISO 13958:2002(E)
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ISO 13958:2002(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO
member bodies). The work of preparing International Standards is normally carried out through ISO technical
committees. Each member body interested in a subject for which a technical committee has been established has
the right to be represented on that committee. International organizations, governmental and non-governmental, in
liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are circulated to the member bodies for voting.
Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO13958 was prepared by Technical Committee ISO/TC150, Implants for surgery,
Subcommittee SC 2, Cardiovascular implants.
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ISO 13958:2002(E)
Introduction
Dialysing fluids contain electrolytes in concentrations approaching that of the composition of normal extracellular
body fluid. They can also contain non-electrolytes such as dextrose. Due to large volumes employed, dialysing fluids
are generally prepared by diluting concentrates with water of suitable quality. Concentrates may be supplied in liquid
or powder form.
Acid component concentrate for blending with bicarbonate, and acetate concentrate for use singly do not support
bacterial growth. Bicarbonate concentrates can support bacterial growth. The preparation of bicarbonate
concentrates should be made utilizing raw materials and techniques so that any microbial and chemical
contamination is minimized. The concentrates should be stored in conditions that assure the maintenance of this low
level.
During the dilution and use of these concentrates, precautions should be observed to minimize any microbial
contamination.
The final dialysing fluids are produced from concentrates manufactured, packaged and labelled according to this
International Standard, mixed with large proportions of water in accordance with ISO 13959. Operation of water
treatment equipment and the handling of concentrates and the haemodialysis system are the responsibility of the
haemodialysis facility.
Because these final mixed dialysing fluids are not within the control of manufacturers, this International Standard
cannot address those vital clinical technical processes. Haemodialysis professionals make choices about the various
applications (haemodialysis, haemodiafiltration, haemofiltration, reprocessing of devices) and need to understand
the risks of each and the requirements for safety of fluids used for each therapy.
This International Standard is primarily directed at manufacturers of concentrates. However, it may also be used by
haemodialysis facilities, which bear the ultimate responsibility for safe and appropriate use of dialysing fluid.
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INTERNATIONAL STANDARD ISO 13958:2002(E)
Concentrates for haemodialysis and related therapies
1 Scope
This International Standard is applicable to dry and liquid concentrates to be diluted for use as dialysing fluids in
haemodialysis or haemodiafiltration. It addresses chemical quality and purity, microbial contamination, handling,
measurement and labelling of concentrates, the requirements for containers and the tests to monitor concentrates.
This International Standard does not address the final mixing and use of these concentrates and treated water in
such therapies. That operation is the sole responsibility of dialysis professionals.
This International Standard is not applicable to dialysing-fluid regeneration systems.
2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, this publication do not
apply. However, parties to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent edition of the normative document indicated below. For undated references,
the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of
currently valid International Standards.
ISO 13959, Water for haemodialysis and related therapies
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
acetate dialysing fluid
dialysing fluid without bicarbonate, using acetate as a substitute
NOTE Acetate dialysing fluid is generally produced from a single concentrate.
3.2
anion
molecule or atom carrying a negative charge
3.3
batch system
system in which water and concentrate(s) are mixed in a batch, which is then used for haemodialysis or
haemodiafiltration
3.4
bicarbonate dialysing fluid
dialysing fluid containing physiological or higher concentrations of bicarbonate and small quantities of sodium
acetate
NOTE Bicarbonate dialysing fluid is produced by mixing two concentrates.
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ISO 13958:2002(E)
3.5
cation
molecule or atom carrying a positive charge
3.6
dialysing fluid
dialysis fluid
dialysate
fluid which is intended to exchange solutes with blood during haemodialysis or haemodiafiltration
NOTE It does not include infusion fluid used in haemodiafiltration.
3.7
electrolyte
any ion, or solution of ions, capable of conducting electricity
3.8
microbial
referring to microorganisms such as bacteria, fungi, etc.
...
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