INTERNATIONAL ISO

STANDARD 23500-2

First edition
2019-02

Preparation and quality management

of fluids for haemodialysis and related
therapies —
Part 2:
Water treatment equipment for
haemodialysis applications and
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related therapies
(standards.iteh.ai)
Préparation et management de la qualité des liquides d'hémodialyse
et deISO
thérapies annexes —
23500-2:2019
Partie 2: Équipement de traitement de l'eau pour des applications en
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hémodialyse et aux thérapies apparentées
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Reference number
ISO 23500-2:2019(E)

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ISO 23500-2:2019(E)


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ISO 23500-2:2019
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 ISO 23500-2:2019(E)


Contents Page

Foreword...........................................................................................................................................................................................................................................v
Introduction................................................................................................................................................................................................................................. vi
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........................................................................................................................................................................................................... 2
4.1 Dialysis water quality requirements..................................................................................................................................... 2
4.1.1 General...................................................................................................................................................................................... 2
4.1.2 Chemical contaminant requirements............................................................................................................. 2
4.1.3 Organic Carbon, pesticides and other chemicals.................................................................................. 3
4.1.4 Microbiology of dialysis water.............................................................................................................................. 3
4.2 Water treatment equipment requirements..................................................................................................................... 4
4.2.1 General...................................................................................................................................................................................... 4
4.2.2 Backflow prevention device.................................................................................................................................... 5
4.2.3 Tempering valves.............................................................................................................................................................. 5
4.2.4 Sediment filters.................................................................................................................................................................. 5
4.2.5
4.2.6
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Cartridge filters.................................................................................................................................................................. 5
Softeners.................................................................................................................................................................................. 5
4.2.7 (standards.iteh.ai)
Anion exchange resin tank....................................................................................................................................... 5
4.2.8 Carbon media....................................................................................................................................................................... 5
4.2.9 Chemical injectionISO systems
23500-2:2019 ...................................................................................................................................... 7
4.2.10https://standards.iteh.ai/catalog/standards/sist/af8fcef6-91f5-4f73-931d-
Reverse osmosis................................................................................................................................................................ 7
4.2.11 Deionization364d2ead75c7/iso-23500-2-2019
.......................................................................................................................................................................... 8
4.2.12 Bacteria and endotoxin retentive filters....................................................................................................... 8
4.2.13 Storage and distribution of dialysis water.................................................................................................. 8
5 Testing........................................................................................................................................................................................................................... 10
5.1 Conformity with dialysis water quality requirements........................................................................................ 10
5.1.1 General................................................................................................................................................................................... 10
5.1.2 Microbiology of dialysis water........................................................................................................................... 10
5.1.3 Maximum level of chemical contaminants.............................................................................................. 11
5.2 Conformity with water treatment equipment requirements....................................................................... 12
5.2.1 General................................................................................................................................................................................... 12
5.2.2 Backflow prevention devices.............................................................................................................................. 13
5.2.3 Tempering valves........................................................................................................................................................... 13
5.2.4 Sediment filters............................................................................................................................................................... 13
5.2.5 Cartridge filters............................................................................................................................................................... 13
5.2.6 Softeners............................................................................................................................................................................... 13
5.2.7 Anion exchange resin tanks.................................................................................................................................. 13
5.2.8 Carbon media.................................................................................................................................................................... 13
5.2.9 Chemical injection systems................................................................................................................................... 14
5.2.10 Reverse osmosis............................................................................................................................................................. 14
5.2.11 Deionization....................................................................................................................................................................... 14
5.2.12 Endotoxin retentive filters..................................................................................................................................... 14
5.2.13 Storage and distribution of dialysis water............................................................................................... 14
6 Labelling...................................................................................................................................................................................................................... 15
6.1 General......................................................................................................................................................................................................... 15
6.2 Device markings.................................................................................................................................................................................. 15
6.3 Product literature............................................................................................................................................................................... 15
Annex A (informative) Rationale for the development and provisions of this document..........................18

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Annex B (informative) ......................................................................................................................................................................................................29

Bibliography.............................................................................................................................................................................................................................. 32

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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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
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World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www​.iso​
.org/iso/foreword​.html. (standards.iteh.ai)
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems.
ISO 23500-2:2019
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This first edition cancels and replaces ISO 26722:2014, which has been technically revised. The main
364d2ead75c7/iso-23500-2-2019
changes compared to the previous edition are as follows:
— The document forms part of a revised and renumbered series dealing with the preparation and
quality management of fluids for haemodialysis and related therapies. The series comprise
ISO 23500‑1 (previously ISO 23500), ISO 23500‑2, (previously ISO 26722), ISO 23500‑3, (previously
ISO 13959), ISO 23500‑4, (previously ISO 13958), and ISO 23500‑5, (previously ISO 11663).
A list of all parts in the ISO 23500 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

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ISO 23500-2:2019(E)


Introduction
This document reflects the conscientious efforts of concerned physicians, clinical engineers, nurses,
dialysis technicians, and dialysis patients, in consultation with device manufacturers and regulatory
authority 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 documents, does not imply unanimity of opinion, but rather reflects the
compromise necessary in some instances when a variety of interests should be merged.
This document applies to individual water treatment devices and to water treatment systems
assembled from one or more of these devices. In the first instance, this document 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 document 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 document is written principally to address water treatment systems
for dialysis facilities treating multiple patients. However, many of its provisions apply equally 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.
Increasingly, self-contained, integrated systems designed and validated to produce water and dialysis
fluid are becoming available and used clinically. The provisions included in this document apply to
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systems assembled from individual components. Consequently, some of the provisions in ISO 23500-1
and ISO 23500-2 might not apply to integrated systems, however such systems are required to comply
(standards.iteh.ai)
with ISO 23500-3, ISO 23500-4, and ISO 23500-5. In order to ensure conformity when using such
systems, the user shall follow the manufacturer's instructions regarding the operation, testing, and
maintenance of such systems in order to ensureISO that the system is being operated under the validated
23500-2:2019
conditions. https://standards.iteh.ai/catalog/standards/sist/af8fcef6-91f5-4f73-931d-
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This document helps protect haemodialysis patients from adverse effects arising from known chemical
and microbial contaminants found in water supplies. However, 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 document
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. Requirements
and recommendations on the preparation and handling of water and dialysis fluid in a dialysis facility
are provided in ISO 23500-5. The rationale for the development of this document is given in Annex A.
Since the chemical and microbiological content of the water produced need to meet the requirements of
ISO 23500-3, the maximum allowable levels of contaminants are listed in Annex B (Tables B.1 and B.2).
The values shown include the anticipated uncertainty associated with the analytical methodologies
listed in Table B.3.

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INTERNATIONAL STANDARD ISO 23500-2:2019(E)

Preparation and quality management of fluids for

haemodialysis and related therapies —
Part 2:
Water treatment equipment for haemodialysis
applications and related therapies

1 Scope

1.1 General
This document 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 document covers devices used to treat potable water intended for use in the delivery of
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haemodialysis and related therapies, including water used for:
a) (standards.iteh.ai)
the preparation of concentrates
facility;
from powder or other highly concentrated media at a dialysis

b) the preparation of dialysis fluid, including ISO 23500-2:2019

dialysis fluid that can be used for the preparation of
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substitution fluid;
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c) the reprocessing of dialysers intended for single use where permitted for multiple uses,
d) the reprocessing of dialysers not specifically marked as intended for single use.
This document includes 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 the
devices are water purification devices, online water quality monitors (such as conductivity monitors),
and piping systems for the distribution of dialysis water.

1.3 Exclusions
This document excludes 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 documents
such as ISO 23500-4 and ISO 23500-5,
This document also excludes the on-going surveillance of the purity of water used for dialysis fluid,
concentrate preparation, or dialyser reprocessing which is addressed in ISO 23500-1.

2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.

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ISO 23500-1:2019, Preparation and quality management of fluids for haemodialysis and related
therapies — Part 1: General requirements
ISO 23500-3:2019, Preparation and quality management of fluids for haemodialysis and related
therapies — Part 3: Water for haemodialysis and related therapies
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

3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 23500-1 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:​//www​.iso​.org/obp
— IEC Electropedia: available at http:​//www​.electropedia​.org/
3.1
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.
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4 Requirements (standards.iteh.ai)
ISO 23500-2:2019
4.1 Dialysis water quality requirements
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4.1.1 General

The requirements contained in this document 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. 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 Chemical contaminant requirements

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 23500-3:2019, 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 document 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 document. 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 document at the time of installation.

For disposable water treatment and distribution systems that have been validated to produce dialysis
water meeting the quality requirements of this document for a specified time, surveillance of the

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 ISO 23500-2:2019(E)


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 surveilling 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 closely observed 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 surveillance of the levels of chemical contaminants in the water and for complying
with the requirements of this document.

4.1.3 Organic Carbon, pesticides and other chemicals

The presence of organic compounds, such as pesticides, polycyclic aromatic hydrocarbons and other
chemicals such as pharmaceutical products and endocrine disruptors in respect of hemodialysis
patients are difficult to define. Consequences of exposure are probably of a long-term nature and it is
technically difficult and costly to measure these substances on a routine basis. Furthermore, there is
an absence of evidence of their widespread presence in water although it is recognized that inadvertent
discharges are possible. In view of this, it is not possible to currently define limits for their presence in
water used in the preparation of dialysis fluid.
Nanofiltration and reverse osmosis are capable of significant rejection of many such compounds.
Granular Activated Carbon (GAC) is also highly effective at removing majority of such compounds.
However, as Granular Activated Carbon is widely used in the removal of chlorine/chloramine, their use
in the removal of organic carbons, pesticides and other chemicals will be dependent upon the size of the
carbon filters and/or beds and users shall be aware of appropriate dimensioning since the majority of
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carbon valences might be already occupied and not available for further removal activity.

4.1.4
(standards.iteh.ai)
Microbiology of dialysis water

Dialysis water used to prepare dialysis ISO fluid or concentrates from powder at a dialysis facility, or to
23500-2:2019
reprocess dialysers for multiple uses, shall contain a total viable microbial count and endotoxin levels
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as specified in ISO 23500-3. 364d2ead75c7/iso-23500-2-2019

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
document, 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 document. 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 document at the time of installation.

For disposable water treatment systems validated by the manufacturer to produce dialysis water
meeting the quality requirements of this document for a specified time, surveillance 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 surveilling the 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 observed as outlined for non-validated systems.
NOTE 2 Following installation of a water treatment, storage, and distribution system, the user is responsible
for continued surveillance of the water bacteriology of the system and for complying with the requirements of
this document, including those requirements related to action levels.

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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 4.1.2. 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 4.1.4.
The water treatment and distribution system should include appropriate pressure gauges, flow meters,
sample ports, and other ancillary equipment necessary to allow surveillance 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.
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Operating controls shall be positioned so as to minimize inadvertent resetting.
(standards.iteh.ai)
Electrical circuits shall be separate from hydraulic circuits and adequately protected from fluid leaks.
ISO 23500-2:2019
4.2.1.2 Materials compatibility
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Materials that are in contact with dialysis 364d2ead75c7/iso-23500-2-2019
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 non-reactive materials (e.g.
plastics) or appropriate stainless steel. The use of materials known to cause toxicity in haemodialysis,
such as copper, brass, galvanized metal, or aluminium, are specifically prohibited at any point beyond
the water treatment device used to remove contaminating metal ions, most commonly a reverse
osmosis system or a deionizer. The materials of any water treatment devices (including piping, storage,
and distribution systems) shall be compatible with the means used to disinfect those devices. Chemicals
infused into the water in the pre-treatment section, such as chlorine, acid, flocculants, and complexing
agents, shall be adequately removed from dialysis water before they reach any point of use. Monitors or
specific test procedures to verify removal of additives shall be provided.

4.2.1.3 Regenerated or reconstituted devices

All devices that are regenerated or reconstituted at a site remote from the dialysis facility, such as
deionizers, shall be disinfected at the time of regeneration or reconstitution, so that contaminated
water is not reintroduced into the system after regeneration or reconstitution. Separate processes shall
be used to ensure no intermixing of devices or their component parts between devices returned from
medical or potable water users and devices returned from non-potable water users.

4.2.1.4 Disinfection protection

When the manufacturer recommends chemical disinfectants [see 6.3 x)], means shall be provided to
restore the equipment and the system in which it is installed, to a safe condition relative to residual
disinfectant prior to the dialysis water being used for dialysis applications. When recommending
chemical disinfectants, the manufacturer shall also recommend methods for testing for residual
levels of the disinfectants. When disinfection is accomplished automatically by chemical disinfectant,

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 ISO 23500-2:2019(E)


including ozone, or by high temperature procedures, activation of the disinfection system shall result in
activation of a warning system and measures to prevent patient exposure to an unsafe condition.
If sodium hypochlorite (bleach) is used for cleaning or disinfecting the internal pathways of dialysis
equipment, including but not limited to water treatment loops, concentrate containers, mixers,
and delivery systems, the post rinse water residual level of free chlorine shall be as specified by the
manufacturer’s instructions.

4.2.2 Backflow prevention device

A backflow prevention device to isolate the water treatment system from the potable water supply
according to local plumbing codes should be fitted to all water treatment systems.

4.2.3 Tempering valves

Tempering valves, if used, shall be sized to accommodate the anticipated range of flow rates of hot and
cold water. They shall be fitted with a mechanism to prevent backflow of water into the hot and cold
water lines and with a means to measure the outlet water temperature.

4.2.4 Sediment filters

Sediment filters should have an opaque housing or other means to inhibit proliferation of algae. Filters
should be fitted with pressure gauges on the inlet and outlet water lines to measure the pressure drop,
ΔP, across the filter.
NOTE
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Sediment filters are also known as multimedia or sand filters.

4.2.5 Cartridge filters

(standards.iteh.ai)
ISO 23500-2:2019
Cartridge filters should have an opaque housing or other means to inhibit proliferation of algae. Filters
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should be fitted with pressure gauges on the inlet and outlet water lines to measure the pressure drop,
364d2ead75c7/iso-23500-2-2019
ΔP, across the filter.

4.2.6 Softeners

Water softeners should be fitted with a mechanism to prevent water containing the high concentrations
of sodium chloride used during regeneration from entering the product water line during regeneration.
Automatic regeneration can be performed on a volume schedule or on a time schedule. For softeners that
are regenerated automatically on a time schedule, the face of the timers used to control the regeneration
cycle should be visible to the user. Operating controls shall be positioned so as to minimize inadvertent
resetting.

4.2.7 Anion exchange resin tank

Anion exchange resin, sometimes referred to as an organic scavenger, can remove organic matter and
other contaminants from the source water and protect carbon media from fouling, which can shorten
its effective life for chlorine/chloramine removal. If an organic scavenger is installed to protect the
carbon media, the scavenger should be installed upstream of the carbon beds. Anion exchange resins
can also be used to remove contaminants that might otherwise foul the reverse osmosis membrane.

4.2.8 Carbon media

Carbon is used to remove small organic compounds, chlorine, and chloramine. At least one carbon bed
or filter should be installed even if the water supply is from a well and no chlorine is present. Carbon
removes organic contaminants from ground water, including solvents, pesticides, industrial wastes,
and substances leaking from underground storage tanks. If chlorine is not present in the water, the
carbon should be changed on a routine schedule. When carbon is used for the removal of chloramine, it

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shall be adapted specifically to the maximum anticipated water flow rate of the system and the level of
chloramine in the feed water.
Due to the risk of harm to a patient in the event of total chlorine breakthrough or organic contamination,
the system shall be designed to prevent patient exposure to unsafe product water in the event of a
single point failure. Protective measures can be incorporated into the system design through several
means including:
— the use of two carbon beds in series with off-line sampling of product water from the first bed in
each series (see off-line testing in ISO 23500-1:2019, 7.3.5). Each of the carbon beds shall have an
EBCT of at least 5 min at the maximum product water flow rate (a total EBCT of at least 10 min);
— the use of redundant means of chloramines removal with off-line sampling of product water after
the primary device (see off-line testing in ISO 23500-1:2019, 7.3.5). Possible alternatives include a
granular activated carbon bed followed by a dense carbon block or two carbon block filters in series;
— the use of carbon systems used to prepare water for portable dialysis systems are exempt from
the requirement for the second carbon and a 10 min EBCT, provided there is a redundant means
of chloramine removal with off-line sampling after the primary device (see off-line testing in
ISO 23500-1:2019, 7.3.5);
— the use of batch systems used to prepare water for portable dialysis systems are exempt from the
requirement for the second carbon and a 10 min EBCT, provided there is a redundant means of
chloramine removal with off-line sampling after batch production (see chlorine test methods in
ISO 23500-1:2019, 7.3.5);
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— the use of carbon media with duration or process volume limitation in conjunction with online
surveillance of the product water and diversion of the product water to drain or a blocking valve
(standards.iteh.ai)
with system shutdown, should the total chlorine level in the product water exceed 0,1 mg/l (see
online testing in ISO 23500-1:2019, 7.3.5). Periodic testing of the online monitor and the frequency
ISO 23500-2:2019instructions. If an online monitor failure
of the testing is specified per the system manufacturer’s
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occurs, manual testing can be implemented to observe for chlorine and chloramines for 72 h similar
364d2ead75c7/iso-23500-2-2019
to dual carbon designs as in ISO 23500-1:2019, B.2.5.
To avoid overly large beds, carbon beds are sometimes arranged as parallel sets, each set consisting
of two beds in series. The beds are equally sized and water flows in parallel through each set. In this
situation, each bed shall have a minimum EBCT of 5 min at the maximum flow rate through the bed.
When parallel sets of beds are used, the piping should be designed to minimize differences in the
resistance to flow from inlet and outlet between each parallel set of beds in order to ensure that water
flows equally through all beds. A means shall be provided to sample the product water from the first
bed in each series‐connected pair and a sample port should be installed following the carbon beds for
use in the event of total chlorine breaking through the first bed in a series‐connected pair.
In situations where chloramine is not used to disinfect the water, and the ammonium [NH4+ formed
by the protonation of ammonia (NH3)] level in the water is low, one carbon bed or a carbon cartridge
filter with a shorter EBCT might be sufficient. Exhausted carbon media shall be discarded and replaced
with new media according to a replacement schedule determined by regular surveillance. For example,
with two beds, when testing between the beds shows that the first bed is exhausted, the second bed
should be moved into the first position, the second bed replaced with a new bed, and the exhausted bed
discarded.
Granular activated carbon with an iodine number greater than 900 is considered optimal for chlorine/
chloramine removal. However, some source waters, such as those with a high organic content could
require alternate types of carbon that are more resistant to organic fouling. These types of carbon
can have iodine numbers less than 900. When other forms of carbon or granular activated carbon
with an iodine number of less than 900 are used, the manufacturer shall provide performance data
to demonstrate that each adsorption bed has the capacity to reduce the total chlorine concentration
in the feed water to less than 0,1 mg/l when operating at the maximum anticipated flow rate for the
maximum time interval between scheduled testing of the product water for total chlorine. Regenerated
carbon shall not be used. Automatically backwashed carbon beds should be fitted with a mechanism

6  © ISO 2019 – All rights reserved

 ISO 23500-2:2019(E)


to prevent water containing chlorine or chloramine from entering the feed water line of downstream
purification devices, such as reverse osmosis, while the carbon beds are being backwashed. For carbon
beds that are backwashed automatically on a time schedule, the face of the timers used to control the
backwash cycle should be visible to the user and the timer should be set so that backwashing occurs
when dialysis is not being performed.
In some instances, activated carbon might not provide adequate removal of chloramine. Inadequate
removal of chloramine can occur when the pH of the water is high, or when municipal water contains
high levels of organic material or additives, such as orthophosphate for lead and copper control.
Inadequate removal of chloramine can also appear to occur when naturally‐occurring N‐chloramines
are present in the water. N‐chloramines are relatively large molecules and are removed by reverse
osmosis; however, they test positive in the assays used for chloramine, thus giving the impression of
inadequate chloramine removal.
In these circumstances, other strategies for chloramine removal might be needed. One approach that
has been used successfully is the injection of sodium bisulphite prior to the reverse osmosis system.
Other approaches include installing anion exchange resin before the carbon beds to remove organic
matter and other contaminants that might foul the activated carbon, or the injection of a mineral acid
before the carbon beds to reduce the pH of alkaline feed water.
If carbon beds fitted with an online monitor for measuring total chlorine in the product water are used,
there should be a means of preventing patient exposure to unsafe product water, such as the diversion
of the product water to drain or a system shutdown, should the total chlorine level in the product water
exceed 0,1 mg/l. Accompanying visual and/or audible alarms shall meet the relevant requirements of
IEC 60601‐1‐8; for low‐priority alarms if product water is diverted to drain or the system is shut down;
iTeh STANDARD PREVIEW
otherwise, the alarms shall meet the relevant requirements of IEC 60601‐1‐8 for high priority alarms.
(standards.iteh.ai)
In addition, the sound emitted by the audible alarm shall be at least 65 dB (“A” scale) at 3 m and it shall
not be possible to silence the alarm for more than 180 s. Alarms shall be situated so that they ensure a
prompt response by personnel in the patient care area.
ISO 23500-2:2019
https://standards.iteh.ai/catalog/standards/sist/af8fcef6-91f5-4f73-931d-
If the online monitor is placed between two carbon filters in series, a low‐priority alarm can be accepted
364d2ead75c7/iso-23500-2-2019
as long as manual surveillance is performed after the last filter or bed in the event of an alarm.

4.2.9 Chemical injection systems

Sodium bisulphite injected into the source water can be an effective means of reducing chlorine and
chloramine concentrations. Ascorbic acid has also been used for this purpose. In addition, reducing
the pH of alkaline feed water by the injection of mineral acids can enhance the efficiency of granular
activated carbon. Chemical injection systems shall include a means of regulating the metering pump to
control the addition of chemical. This control system shall be designed to tightly control the addition of
chemical. The control system shall ensure that chemical is added only when water is flowing through
the pre-treatment cascade and that it is added in fixed proportion to the water flow or based on some
continuously observed parameter, such as pH, using an automated control system. If an automated
control system is used to inject the chemical, there shall be an independent monitor of the controlling
parameter. Monitors shall be designed so that the monitor cannot be disabled while a patient is at risk,
except for brief, necessary periods of manual control with the operator in constant attention.

4.2.10 Reverse osmosis

When used to prepare water for haemodialysis applications, either alone or as the last stage in a
purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting
the requirements of 4.1, when tested with the typical feed water of the user, in accordance with the
methods described in 5.1.
Reverse osmosis devices shall be equipped with online monitors that allow determination of product
water conductivity and should be equipped with monitors that determine rejection rate based on
conductivity. Monitors that display resistivity or total dissolved solids (TDS) could be used in place of
conductivity monitors. Resistivity, conductivity, or TDS monitors shall be temperature-compensated,

© ISO 2019 – All rights reserved  7