SIST EN ISO 26722:2016

SLOVENSKI STANDARD
01-februar-2016
Oprema za pripravo vode za uporabo pri hemodializi in podobnih terapijah (ISO
26722:2014)
Water treatment equipment for haemodialysis applications and related therapies (ISO
26722:2014)
Ausstattung zur Wasseraufbereitung zur Verwendung in der Hämodialyse und in
verwandten Therapien (ISO 26722:2014)
Équipement de traitement de l'eau pour des applications en hémodialyse et aux
thérapies apparentées (ISO 26722:2014)
Ta slovenski standard je istoveten z: EN ISO 26722:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 26722
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Water treatment equipment for haemodialysis
applications and related therapies (ISO 26722:2014)
Équipement de traitement de l'eau pour des Ausstattung zur Wasseraufbereitung zur Verwendung
applications en hémodialyse et aux thérapies in der Hämodialyse und in verwandten Therapien (ISO
apparentées (ISO 26722:2014) 26722:2014)
This European Standard was approved by CEN on 23 November 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 26722:2015 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 5
European foreword
The text of ISO 26722:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for
surgery” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 26722:2015 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2016, and conflicting national standards shall be
withdrawn at the latest by June 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1 — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO or IEC
standard
)
ISO 13959:2014 ISO 13959:2014
EN ISO 13959:2015
ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007
IEC 60601-1-8 EN 60601-1- IEC 60601-1-8:2006+A1:2012
8:2007+Cor.:2010+A1:2013
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 26722:2014 has been approved by CEN as EN ISO 26722:2015 without any modification.

1)
To be published.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of the New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of
this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption
of conformity with the corresponding Essential Requirements of that Directive and associated EFTA
regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential
requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on
medical devices
Essential Requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
4.2.1.1 7.3
4.2.1.1 7.5
4.2.1.4 8
1.2, 4.1.1 9.1
4.1.1 13.3. (a)
4.2.1.4 13.3. (i)
1.2, 1.3 13.6. (c)
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 26722
Second edition
2014-04-01
Water treatment equipment for
haemodialysis applications and
related therapies
Équipement de traitement de l’eau pour des applications en
hémodialyse et aux thérapies apparentées
Reference number
ISO 26722:2014(E)
©
ISO 2014
ISO 26722:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 26722:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
1.1 General . 1
1.2 Inclusions . 1
1.3 Exclusions . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Requirements . 7
4.1 Dialysis water quality requirements . 7
4.2 Water treatment equipment requirements . 8
5 Tests .13
5.1 Compliance with dialysis water quality requirements .13
5.2 Compliance with water treatment equipment requirements .15
6 Labelling .17
6.1 General .17
6.2 Device markings .17
6.3 Product literature .18
Annex A (informative) Rationale for the development and provisions of this
International Standard .20
Annex B (informative) Reference tables from ISO 13959 .30
Bibliography .33
ISO 26722:2014(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 26722:2009), which has been technically
revised.
iv © ISO 2014 – All rights reserved

ISO 26722:2014(E)
Introduction
This International Standard reflects the conscientious efforts of concerned physicians, clinical
engineers, nurses, dialysis technicians, and dialysis patients, in consultation with device manufacturers
and government representatives, to develop an International Standard for performance levels that could
be reasonably achieved at the time of publication. The term “consensus,” as applied to the development
of voluntary medical device International Standards, does not imply unanimity of opinion, but rather
reflects the compromise necessary in some instances when a variety of interests should be merged.
The provisions of this International Standard apply to individual water treatment devices and to water
treatment systems assembled from one or more of these devices. In the first instance, this International
Standard is directed at the individual or company that specifies the complete water treatment system
and, second, at the supplier who assembles and installs the system. Since systems can be assembled from
a number of individual water treatment devices, the provisions of this International Standard are also
directed at the manufacturers of these devices, provided that the manufacturer indicates that the device
is intended for use in haemodialysis applications. This International Standard is written principally
to address water treatment systems for dialysis facilities treating multiple patients. However, many
of its provisions equally apply to water treatment systems used in applications where a single patient
is treated, such as in a home dialysis or acute hospital dialysis setting. Specifically, requirements for
the chemical and microbiological quality of water are considered to apply in all settings, regardless of
whether a single patient or many patients are being treated.
The verbal forms used in this International Standard conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
International Standard,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this International Standard, and
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
The requirements established by this International Standard should help protect haemodialysis
patients from adverse effects arising from known chemical and microbial contaminants found in water
supplies. However, proper dialysis and patient safety is ultimately dependent on the quality of the
dialysis fluid. Since the manufacturer or supplier of water treatment equipment does not have control
over the dialysis fluid, any reference to dialysis fluid in this International Standard is for clarification
only and not a requirement of the manufacturer. The responsibility for assuring that the dialysis
fluid is not contaminated, mismatched, or otherwise damaging to the patient rests with the clinical
professionals caring for the patient under the supervision of the medical director. Recommendations on
the preparation and handling of water and dialysis fluid in a dialysis facility are provided in ISO 23500.
INTERNATIONAL STANDARD ISO 26722:2014(E)
Water treatment equipment for haemodialysis
applications and related therapies
1 Scope
1.1 General
This International Standard is addressed to the manufacturer and/or supplier of water treatment
systems and/or devices used for the express purpose of providing water for haemodialysis or related
therapies.
1.2 Inclusions
This International Standard covers devices used to treat water intended for use in the delivery of
haemodialysis and related therapies, including water used for: (1) the preparation of concentrates from
powder or other highly concentrated media at a dialysis facility; (2) the preparation of dialysis fluid,
including dialysis fluid that can be used for the preparation of substitution fluid; (3) the reprocessing of
dialysers for multiple uses.
Included within the scope of this International Standard are all devices, piping and fittings between
the point at which potable water is delivered to the water treatment system, and the point of use of the
dialysis water. Examples of devices included within the scope of this International Standard are water
purification devices, online water quality monitors (such as conductivity monitors), and piping systems
for the distribution of dialysis water.
1.3 Exclusions
Excluded from the scope of this International Standard are dialysis fluid supply systems that proportion
water and concentrates to produce dialysis fluid, sorbent dialysis fluid regeneration systems that
regenerate and recirculate small volumes of the dialysis fluid, dialysis concentrates, haemodiafiltration
systems, haemofiltration systems, systems that process dialysers for multiple uses, and peritoneal
dialysis systems. Some of these devices, such as dialysis fluid delivery systems and concentrates, are
addressed in other International Standards. Also excluded from the scope of this International Standard
are requirements for the ongoing monitoring of the purity of water used for dialysis fluid, concentrate
preparation, or dialyser reprocessing.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 13959:2014, Water for haemodialysis and related therapies
ISO 14971:2007, Medical devices — Application of risk management to medical devices
IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential
performance – Collateral standard: General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
ISO 26722:2014(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
acid concentrate
A-concentrate
acidified concentrated mixture of salts that, when diluted with dialysis water and bicarbonate
concentrate, yields dialysis fluid for use in dialysis
Note 1 to entry: The term “acid” refers to the small amount of acid (for example, acetic acid or citric acid) that is
included in the concentrate.
Note 2 to entry: Acid concentrate can contain glucose.
Note 3 to entry: Acid concentrate can be in the form of a liquid, a dry powder, other highly concentrated media, or
some combination of these forms.
3.2
action level
concentration of a contaminant at which steps should be taken to interrupt the trend toward higher,
unacceptable levels
3.3
bicarbonate concentrate
B-concentrate
concentrated preparation of sodium bicarbonate that, when diluted with dialysis water and acid
concentrate, makes dialysis fluid used for dialysis
Note 1 to entry: Sodium bicarbonate is also known as sodium hydrogen carbonate.
Note 2 to entry: Some bicarbonate concentrates also contain sodium chloride.
Note 3 to entry: Bicarbonate concentrate can be in the form of a liquid or a dry powder.
Note 4 to entry: Dry sodium bicarbonate, without added sodium chloride, is also used in concentrate generators
to produce a concentrated solution of sodium bicarbonate used by the dialysis machine to make dialysis fluid.
3.4
biofilm
microbially derived sessile community characterized by cells that are irreversibly attached to a
substratum or interface or to each other, are imbedded in a matrix of extracellular polymeric substances
that they have produced, and exhibit an altered phenotype with respect to growth rate and gene
transcription
Note 1 to entry: The matrix, a slimy material secreted by the cells, protects the bacteria from antibiotics and
chemical disinfectants.
Note 2 to entry: A certain amount of biofilm formation is considered unavoidable in dialysis water systems. When
the level of biofilm is such that the action levels for microorganisms and endotoxins in the dialysis water cannot
be routinely achieved, the operation of the system is compromised from a medical and technical point of view.
This level of biofilm formation is often referred to as biofouling.
3.5
chlorine, combined
chlorine that is chemically combined, such as in chloramine compounds
Note 1 to entry: There is no direct test for measuring combined chlorine, but it can be measured indirectly by
measuring both total and free chlorine and calculating the difference.
2 © ISO 2014 – All rights reserved

ISO 26722:2014(E)
3.6
chlorine, free
chlorine present in water as dissolved molecular chlorine (Cl), hypochlorous acid (HOCl), and hypoclorite
-
ion (OCl )
Note 1 to entry: The three forms of free chlorine exist in equilibrium.
3.7
chlorine, total
sum of free and combined chlorine
Note 1 to entry: Chlorine can exist in water as dissolved molecular chlorine, hypochlorous acid, and/or hypochlorite
ion (free chlorine) or in chemically combined forms (combined chlorine). Where chloramine is used to disinfect
water supplies, chloramine is usually the principal component of combined chlorine.
3.8
concentrate generator
system where the concentrate is delivered to the user as a powder in a container, suitable for attachment
to the dialysis machine with which it is intended to be used, and then the powder is converted into a
concentrated solution by the dialysis machine
Note 1 to entry: The solution produced by the concentrate generator is used by the dialysis machine to make the
final dialysis fluid delivered to the dialyser.
3.9
device
individual water purification unit, such as a softener, carbon bed, reverse osmosis unit, or deionizer
Note 1 to entry: This term is synonymous with the term “component” as used by the US. Food and Drug
[26]
Administration.
3.10
dialysis fluid
dialysate
dialysis solution
aqueous fluid containing electrolytes and, usually, buffer and glucose, which is intended to exchange
solutes with blood during haemodialysis
Note 1 to entry: The term “dialysis fluid” is used throughout this International Standard to mean the fluid made
from dialysis water and concentrates that is delivered to the dialyser by the dialysis fluid delivery system. Such
phrases as “dialysate” or “dialysis solution” are used in place of dialysis fluid in some countries; however, that
usage is discouraged to avoid confusion.
Note 2 to entry: The dialysis fluid entering the dialyser is referred to as “fresh dialysis fluid”, while the fluid
leaving the dialyser is referred to as “spent dialysis fluid.”
Note 3 to entry: Dialysis fluid does not include prepackaged parenteral fluids used in some renal replacement
therapies such as haemodiafiltration and haemofiltration.
3.11
dialysis fluid delivery system
device that prepares dialysis fluid online from dialysis water and concentrates or that stores and
distributes premixed dialysis fluid, circulates the dialysis fluid through the dialyser, monitors the
dialysis fluid for temperature, conductivity (or equivalent), pressure, flow, and blood leaks, and prevents
dialysis during disinfection or cleaning modes
Note 1 to entry: The term includes reservoirs, conduits, proportioning devices for the dialysis fluid, and monitors
and associated alarms and controls assembled as a system for the purposes listed above.
Note 2 to entry: The dialysis fluid supply system might be an integral part of the single-patient dialysis machine
or a centralized preparation system which feeds multiple bedside monitoring systems.
ISO 26722:2014(E)
Note 3 to entry: Dialysis fluid delivery systems are also known as proportioning systems and dialysis fluid supply
systems.
3.12
dialysis water
water that has been treated to meet the requirements of ISO 13959 and which is suitable for use in
haemodialysis applications, including the preparation of dialysis fluid, reprocessing of dialysers,
preparation of concentrates, and preparation of substitution fluid for online convective therapies
3.13
disinfection
destruction of pathogenic and other kinds of microorganisms by thermal or chemical means
Note 1 to entry: Disinfection is a less lethal process than sterilization because it destroys most recognized
pathogenic microorganisms but does not necessarily destroy all microbial forms.
3.14
empty bed contact time
EBCT
time taken by a fluid to pass through an empty volume equal to the volume of a particle bed
Note 1 to entry: EBCT (min) is calculated using the following equation:

EBCT = V/Q
where
V  is the volume of the particle bed in cubic metres (m );

Q  is the flow rate of water through the bed in cubic metres per minute (m /min).
Note 2 to entry: EBCT is used as an indirect measure of how much contact occurs between particles, such as
activated carbon, and water as the water flows through a bed of particles.
3.15
endotoxin
major component of the outer cell wall of gram-negative bacteria
Note 1 to entry: Endotoxins are lipopolysaccharides, which consist of a polysaccharide chain covalently bound
to lipid A. Endotoxins can acutely activate both humoral and cellular host defences, leading to a syndrome
characterized by fever, shaking, chills, hypotension, multiple organ failure, and even death if allowed to enter the
circulation in a sufficient dose. [See also pyrogen (3.26).]
3.16
endotoxin-retentive filter
ETRF
membrane filter used to remove endotoxins and microorganisms from dialysis water or dialysis fluid
Note 1 to entry: The performance of an endotoxin-retentive filter is usually expressed as the logarithmic reduction
value (LRV), defined as log (inlet concentration)/(outlet concentration).
Note 2 to entry: Endotoxin-retentive filters can be configured in a cross-flow or dead-end mode. Some endotoxin-
retentive filters also remove endotoxins by adsorption.
3.17
feed water
water supplied to a water treatment system or an individual component of a water treatment system
4 © ISO 2014 – All rights reserved

ISO 26722:2014(E)
3.18
germicide
agent that kills microorganisms
3.19
haemodiafiltration
form of renal replacement therapy in which waste solutes are removed from blood by a combination of
diffusion and convection through a high-flux membrane
Note 1 to entry: Diffusive solute removal is achieved using a dialysis fluid stream as in haemodialysis. Convective
solute removal is achieved by adding ultrafiltration in excess of that needed to obtain the desired weight loss;
fluid balance is maintained by infusing replacement solution into the blood either before the dialyser (predilution
haemodiafiltration), after the dialyser (postdilution haemodiafiltration), or a combination of the two (mixed
dilution haemodiafiltration).
3.20
haemodialysis
form of renal replacement therapy in which waste solutes are removed primarily by diffusion from
blood flowing on one side of a membrane into dialysis fluid flowing on the other side
Note 1 to entry: Fluid removal that is sufficient to obtain the desired weight loss is achieved by establishing a
hydrostatic pressure gradient across the membrane. This fluid removal provides some additional waste solute
removal, particularly for solutes with higher molecular weight.
3.21
haemofiltration
form of renal replacement therapy in which waste solutes are removed from blood by convection
Note 1 to entry: Convective transport is achieved by ultrafiltration through a high-flux membrane. Fluid balance
is maintained by infusing a replacement solution into the blood either before the haemofilter (predilution
haemofiltration), after the haemofilter (postdilution haemofiltration), or a combination of the two (mixed dilution
haemofiltration).
Note 2 to entry: There is no dialysis fluid stream in haemofiltration.
3.22
manufacturer
entity that designs, manufactures, fabricates, assembles, or processes a finished device
Note 1 to entry: Manufacturers include, but are not limited to, those who perform the functions of contract
sterilization, installation, relabelling, remanufacturing, repacking, or specification development and initial
distributions of foreign entities performing these functions. The term does not cover preparation of concentrates
from prepackaged dry chemicals at a dialysis facility or the handling of bulk concentrates at a dialysis facility
after responsibility for the concentrate is transferred from the manufacturer to the user.
3.23
microfilter
filter designed to remove particles down to 0,1 µm in size
Note 1 to entry: Microfilters have an absolute size cut-off and are available in both dead-end and cross-flow
configurations. Some microfilters can reduce the concentration of endotoxins by adsorption.
3.24
product water
water produced by a water treatment system or by an individual device thereof
3.25
proportioning system
apparatus that proportions dialysis water and haemodialysis concentrate to prepare dialysis fluid
ISO 26722:2014(E)
3.26
pyrogen
fever-producing substance
Note 1 to entry: Pyrogens are most often lipopolysaccharides of gram-negative bacterial origin [see also endotoxin
(3.15)].
3.27
sodium hypochorite
chemical used for disinfection of hemodialysis systems
Note 1 to entry: Commercially available solutions of sodium hypochlorite are known in different countries by
terms such as bleach and javel. These solutions are used for disinfection at concentrations recommended by
equipment manufacturers.
3.28
source water
water entering a dialysis facility from an external supplier, i.e. water from a municipal water supply or
equivalent
Note 1 to entry: Source water is sometimes referred to as feed water and is assumed to be potable water
3.29
storage tank
tank at the user’s facility for storage of source water, dialysis water, or concentrate from bulk deliveries
or for concentrate prepared in bulk at the user’s facility from powder and dialysis water
3.30
substitution fluid
fluid used in haemofiltration and haemodiafiltration treatments which is infused directly into the
patient’s blood as a replacement for the fluid that is removed from the blood by filtration
Note 1 to entry: Substitution fluid is also referred to as substitution solution or replacement solution.
Note 2 to entry: Substitution fluid can also be used for bolus administration, for priming of an extracorporeal
blood circuit, and for returning blood to the patient at the end of a treatment.
3.31
total dissolved solids
TDS
sum of all ions in a solution, often approximated by means of electrical conductivity or resistivity
measurements
Note 1 to entry: TDS measurements are commonly used to assess the performance of reverse osmosis units. TDS
values are often expressed in terms of CaCO , NaCl, KCl, or 442 equivalents in milligrams per litre (mg/l). [442 is a
solution of sodium sulfate (40 %), sodium bicarbonate (40 %), and sodium chloride (20 %) that closely represents
the conductivity to concentration relationship, on average, for naturally occurring fresh water.]
3.32
user
physician or physician’s representative or healthcare professional with a responsibility for the
prescription, production, and delivery of dialysis fluid
3.33
water treatment system
collection of water treatment devices and associated piping, pumps, valves, gauges, etc. that together
produce water meeting the requirements of ISO 13959 for haemodialysis applications and deliver it to
the point of use
6 © ISO 2014 – All rights reserved

ISO 26722:2014(E)
4 Requirements
4.1 Dialysis water quality requirements
4.1.1 General
The requirements contained in this International Standard apply to the dialysis water as it enters the
equipment used to prepare concentrates from powder or other concentrated media at a dialysis facility,
to prepare dialysis fluid, or to reprocess dialysers for multiple uses. As such, these requirements apply
to the water treatment system as a whole and not to each of the individual devices that make up the
system. However, collectively, the individual devices shall produce dialysis water that, at a minimum,
meets the requirements of the clause.
4.1.2 Microbiology of dialysis water
Dialysis water used to prepare dialysis fluid or concentrates from powder at a dialysis facility, or to
reprocess dialysers for multiple uses, shall contain a total viable microbial count and endotoxin levels
as specified in ISO 13959.
The manufacturer or supplier of a complete water treatment and distribution system shall demonstrate
that the complete water treatment, storage, and distribution system meets the requirements of this
International Standard, including those related to action levels at the time of installation.
NOTE 1 If the manufacturer or supplier does not install the water storage and distribution system, then the
responsibility of the manufacturer or supplier is limited to demonstrating that the water treatment system,
excluding the water storage and distribution system, meets the requirements of this International Standard.
If individual devices of the water treatment system are provided by different manufacturers or suppliers, the
person or organization specifying the devices is responsible for demonstrating that the complete system meets
the requirements of this International Standard at the time of installation.
For disposable water treatment systems validated by the manufacturer to produce dialysis water
meeting the quality requirements of this International Standard for a specified time, monitoring of the
incoming feed water is required to ensure that the input to the treatment system is in the range for
which the system has been validated. The manufacturer’s recommendations for monitoring the final
dialysis water can be followed when the system is operated according to the manufacturer’s instructions.
Alternatively, the quality of the dialysis water can be monitored as outlined for non-validated systems.
NOTE 2 Following installation of a water treatment, storage, and distribution system, the user is responsible
for continued monitoring of the water bacteriology of the system and for complying with the requirements of this
International Standard, including those requirements related to action levels.
4.1.3 Maximum level of chemical contaminants
Dialysis water used to prepare dialysis fluid or concentrates from powder at a dialysis facility, or to
reprocess dialysers for multiple uses, shall not contain chemical contaminants at concentrations in
excess of those in ISO 13959:2014, Tables 1 and 2 (reproduced as Tables B.1 and B.2). The manufacturer
or supplier of a complete water treatment system shall recommend a system capable of meeting the
requirements of this clause based on the analysis of the feed water. The system design should reflect
possible seasonal variations in feed water quality. The manufacturer or supplier of a complete water
treatment and distribution system shall demonstrate that the complete water treatment, storage, and
distribution system is capable of meeting the requirements of this International Standard at the time of
installation.
NOTE 1 If the manufacturer or supplier does not install the water storage and distribution system, then the
responsibility of the manufacturer or supplier is limited to demonstrating that the water treatment system,
excluding the water storage and distribution system, meets the requirements of this International Standard.
If individual devices of the water treatment system are provided by different manufacturers or suppliers, the
person or organization specifying the devices is responsible for demonstrating that the complete system meets
the requirements of this International Standard at the time of installation.
ISO 26722:2014(E)
For disposable water treatment and distribution systems that have been validated to produce dialysis
water meeting the quality requirements of this International Standard for a specified time, monitoring
of the incoming potable water is required to ensure that the input to the treatment system is in the
range for which the system has been validated. The manufacturer’s recommendation for monitoring
the final dialysis water can be followed when the system is operated according to the manufacturer’s
instructions. Alternatively, the quality of the dialysis water can be monitored as outlined for non-
validated systems.
NOTE 2 Following the installation of a water treatment, storage, and distribution system, the user is
responsible for continued monitoring of the levels of chemical contaminants in the water and for complying with
the requirements of this International Standard.
4.2 Water treatment equipment requirements
4.2.1 General
4.2.1.1 Water treatment system
The supplier of the feed water or the supplier of the water treatment system or a laboratory specified by
the user shall perform chemical analyses on feed water to determine the compatibility of the system with
the feed water and the suitability of the system for providing dialysis water meeting the requirements of
4.1.3. The result of the chemical analyses shall be available to the user in charge of dialysis. In the case of
an individual device, the person incorporating the device into the water treatment system is responsible
for ensuring that incorporation of the device does not compromise the ability of the overall system to
deliver dialysis water capable of meeting the requirements of 4.1.2 and 4.1.3.
The water treatment and distribution system should include appropriate pressure gauges, flow meters,
sample ports, and other ancillary equipment necessary to allow monitoring of the performance of
individual system devices and the system as a whole.
Valves can be included in the water treatment system to allow individual devices to be bypassed when
there is device failure or to facilitate replacement of a device. If it is possible to bypass a device of the
water treatment system, then the manufacturer or installer of that component shall inform the user of
the risks associated with bypassing that device and the need for clearly defining the responsibility for
operating the bypass. Where such valves are installed, however, a means should be included to minimize
the likelihood that the device will be inadvertently bypassed during normal operation of the system.
Operating controls shall be positioned so as to minimize inadvertent resetting.
Electrical circuits shall be separate from hydraulic circuits and adequately protected from fluid leaks.
4.2.1.2 Materials compatibility
Materials that contact dialysis water (including materials used in piping, storage, and distribution
systems) shall not interact chemically or physically with that water so as to adversely affect its purity
or quality. Water-contacting surfaces shall be fabricated from
...