ISO 13959:2002
(Main)Water for haemodialysis and related therapies
Water for haemodialysis and related therapies
This International Standard specifies minimum requirements for water to be used in the preparation of concentrates and dialysing fluids for haemodialysis and haemodiafiltration. This International Standard does not address the operation of water treatment equipment nor the final mixing of treated water with concentrates to produce the fluids used in such therapies. That operation is the sole responsibility of dialysis professionals. This International Standard is not applicable to dialysing-fluid regenerating systems.
Eaux pour hémodialyse et thérapies apparentées
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 13959
First edition
2002-09-15
Water for haemodialysis and related
therapies
Eaux pour hémodialyse et thérapies apparentées
Reference number
ISO 13959:2002(E)
© ISO 2002
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ISO 13959:2002(E)
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ISO 13959:2002(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 ISO13959 was prepared by Technical Committee ISO/TC150, Implants for surgery,
Subcommittee SC 2, Cardiovascular implants.
©
ISO 2002 – All rights reserved iii
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ISO 13959:2002(E)
Introduction
Assurance of adequate water quality is one of the most important aspects of ensuring a safe and effective delivery of
haemodialysis or haemodiafiltration.
Haemodialysis and haemodiafiltration may expose the patient to more than 300 l of water per week across the semi-
permeable membrane of the haemodialyser or haemodiafilter. Healthy individuals seldom have a weekly oral intake
above 12 l. This near 30-fold increase in exposure requires control and monitoring of water quality to avoid excesses
of known or suspected harmful elements. The water to be used for the preparation of dialysing fluid needs treatment
to achieve the required quality. Such a water treatment system may include various components such as water
softeners, sediment filters, reverse osmosis units, deionization units, ultrafilters, microfilters, carbon filters, ultraviolet
disinfection units and storage tanks. The components of the system will be determined by the quality of feed water
and the ability of the overall system to produce and maintain an acceptable product water.
Since knowledge of potential injury from trace elements and contaminants of microbiological origin over long periods
is still growing and techniques for treating drinking water are continuously being developed, this International
Standard will evolve and be refined accordingly.
This International Standard contains minimum chemical and microbiological requirements for the water to be used
for the preparation of dialysing fluids and the necessary steps to assure compliance. Basic criteria for feed water are
included.
The physiological effects attributable to the presence of organic contaminants in product water is an important area
for research. At the time of publication of this International Standard it is premature to specify threshold values below
those published by various regulatory authorities. Users of this International Standard should be aware of the
potential for problems if organic contaminants are present. The total concentration of organic contaminants may be
monitored by measurement of the Total Organic Carbon (TOC). TOC does not indicate the concentration of a specific
contaminant. Specific water treatment may be a concern for areas with known high concentrations of organic
contaminants in feed water.
The final dialysing fluids are produced from concentrates manufactured, packaged and labelled according to
ISO 13958, mixed with large proportions of water according to this International Standard. Operation of water
treatment equipment and haemodialysis systems and handling of concentrates are the responsibility of the
haemodialysis facility.
Because the final mixed dialysing fluid is 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) and need to understand the risks of each and the
requirements for safety for fluids used for each.
Where the product water is used for the reprocessing (cleaning, testing and mixing of disinfectants) of
haemodialysers, the user should ensure that the product water conforms to this International Standard. The product
water should be measured at the input to the reuse equipment.
This International Standard is directed towards manufacturers of water treatment systems and also to haemodialysis
facilities.
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INTERNATIONAL STANDARD ISO 13959:2002(E)
Water for haemodialysis and related therapies
1 Scope
This International Standard specifies minimum requirements for water to be used in the preparation of concentrates
and dialysing fluids for haemodialysis and haemodiafiltration.
This International Standard does not address the opera
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