EN ISO 13959:2015

SLOVENSKI STANDARD
01-februar-2016
Voda za hemodializo in podobne terapije (ISO 13959:2014)
Water for haemodialysis and related therapies (ISO 13959:2014)
Wasser für Hämodialyse und ähnliche Therapien (ISO 13959:2014)
Eau pour hémodialyse et thérapies apparentées (ISO 13959:2014)
Ta slovenski standard je istoveten z: EN ISO 13959:2015
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 13959
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2015
EUROPÄISCHE NORM
ICS 11.040.40
English Version
Water for haemodialysis and related therapies (ISO
13959:2014)
Eau pour hémodialyse et thérapies apparentées (ISO Wasser für Hämodialyse und ähnliche Therapien (ISO
13959:2014) 13959:2014)
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 13959:2015 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 . 4

European foreword
The text of ISO 13959:2014 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 13959:2015 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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
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 13959:2014 has been approved by CEN as EN ISO 13959:2015 without any modification.
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
3.2 8
3.2 13.1
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 13959
Third edition
2014-04-01
Water for haemodialysis and related
therapies
Eau pour hémodialyse et thérapies apparentées
Reference number
ISO 13959:2014(E)
©
ISO 2014
ISO 13959:2014(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
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
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Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 13959:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Terms and definitions . 1
3 Dialysis water requirements . 5
3.1 Dialysis water verification and monitoring . 5
3.2 Microbiological requirements. 5
3.3 Chemical contaminants . 5
4 Tests for compliance with microbiological and chemical requirements .6
4.1 Microbiology of dialysis water . 6
4.2 Chemical contaminants test methods . 7
Annex A (informative) Rationale for the development and provisions of this
International Standard .10
Bibliography .14
ISO 13959:2014(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 third edition cancels and replaces the second edition (ISO 13959:2009), which has been technically
revised.
iv © ISO 2014 – All rights reserved

ISO 13959:2014(E)
Introduction
Assurance of adequate water quality is one of the most important aspects of ensuring a safe and effective
delivery of haemodialysis, haemodiafiltration, or haemofiltration.
This International Standard contains minimum requirements, chemical and microbiological, for the water
to be used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers
and the necessary steps to ensure compliance with those requirements.
Haemodialysis and haemodiafiltration can expose the patient to more than 500 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 over 40-fold increase in exposure requires control and monitoring of
water quality to avoid excesses of known or suspected harmful substances. 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 developed, this International Standard
will evolve and be refined accordingly. The physiological effects attributable to the presence of organic
contaminants in dialysis water are important areas for research. At the time this International Standard
was published it was not possible to specify threshold values for organic contaminants permitted in
water used for the preparation of dialysis fluids, concentrates, and reprocessing of haemodialysers. The
issue of organic contaminants will be reassessed on the next revision of this International Standard.
Within this International Standard, measurement techniques current at the time of publication have
been cited. Other standard methods may be used, provided that such methods have been appropriately
validated and compared to the cited methods.
The final dialysis fluid is produced from concentrates or salts manufactured, packaged, and labelled
according to ISO 13958 mixed with water meeting the requirements of this International Standard.
Operation of water treatment equipment and haemodialysis systems, including ongoing monitoring
of the quality of water used to prepare dialysis fluids, and handling of concentrates and salts are the
responsibility of the haemodialysis facility and are addressed in ISO 23500. Haemodialysis professionals
make choices about the various applications (haemodialysis, haemodiafiltration, haemofiltration) and
should understand the risks of each and the requirements for safety for fluids used for each.
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.
This International Standard is directed towards manufacturers and providers of water treatment
systems and also to haemodialysis facilities.
INTERNATIONAL STANDARD ISO 13959:2014(E)
Water for haemodialysis and related therapies
1 Scope
This International Standard specifies minimum requirements for water to be used in haemodialysis and
related therapies.
This International Standard includes water to be used in the preparation of concentrates, dialysis fluids
for haemodialysis, haemodiafiltration and haemofiltration, and for the reprocessing of haemodialysers.
The operation of water treatment equipment and the final mixing of treated water with concentrates
to produce dialysis fluid are excluded from this International Standard. Those operations are the sole
responsibility of dialysis professionals. This International Standard does not apply to dialysis fluid
regenerating systems.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
action level
concentration of a contaminant at which steps should be taken to interrupt the trend toward higher,
unacceptable levels
2.2
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.
2.3
chlorine, free
chlorine present in water as dissolved molecular chlorine (Cl), hypochlorous acid (HOCl), and
hypochlorite ion (OCl−)
Note 1 to entry: The three forms of free chlorine exist in equilibrium.
2.4
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.
2.5
colony-forming unit
CFU
measure of bacterial or fungal cell numbers that theoretically arise from a single cell when grown on
solid media
Note 1 to entry: Colonies can also form from groups of organisms when they occur in aggregates.
ISO 13959:2014(E)
2.6
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
Administration (see Reference [49]).
2.7
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.
2.8
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 delivery system can be an integral part of the single-patient dialysis machine or
a centralized preparation system which feeds multiple bedside monitoring systems.
Note 3 to entry: Dialysis fluid delivery systems are also known as proportioning systems and dialysis fluid supply
systems.
2.9
dialysis water
water that has been treated to meet the requirements of this International Standard 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
2.10
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.
2.11
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 (2.20)].
2 © ISO 2014 – All rights reserved

ISO 13959:2014(E)
2.12
endotoxin units
EU
units assayed by the Limulus amoebocyte lysate (LAL) test when testing for endotoxins
Note 1 to entry: Because activity of endotoxins depends on the bacteria from which they are derived, their activity
is referred to as a standard endotoxin.
Note 2 to entry: In some countries, endotoxin concentrations are expressed in international units (IU). Since the
harmonization of endotoxin assays, EU and IU are equivalent.
2.13
feed water
water supplied to a water treatment system or an individual component of a water treatment system
2.14
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 a 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).
2.15
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.
2.16
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.
2.17
Limulus amoebocyte lysate test
LAL test
assay used to detect endotoxin
Note 1 to entry: The detection method uses the chemical response of an extract from blood cells of a horseshoe
crab (Limulus polyphemus) to endotoxins.
Note 2 to entry: Amebocyte lysate from a second horseshoe crab, Tachypleus tridentatus, can also be used to
detect endotoxin.
ISO 13959:2014(E)
2.18
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.
2.19
microbiological contamination
contamination with any form of microorganism (e.g. bacteria, yeast, fungi, and algae) or with the by-
products of living or dead organisms such as endotoxins, exotoxins, and cyanobacterial toxins (derived
from blue-green algae)
2.20
pyrogen
fever-producing substance
Note 1 to entry: Pyrogens are most often lipopolysaccharides of gram-negative bacterial origin [see also endotoxin
(2.11)].
2.21
source water
water entering a dialysis facility from an external supplier, such as a municipal water supply
Note 1 to entry: Source water is sometimes referred to as feed water.
2.22
sterile
free from viable microorganisms
Note 1 to entry: “Sterile” can be used to describe a packaged solution that was prepared using a terminal
sterilization process validated according to the methods of the applicable pharmacopoeia. A terminal sterilization
−6
process is commonly defined as one that achieves a sterility assurance level (SAL) of 10 , i.e. assurance of less
than one chance in a million that viable microorganisms are present in the sterilized article.
Note 2 to entry: Alternatively, “sterile” can be used to describe a solution prepared for immediate use by a
continuous process, such as filtration, that has been validated according to the methods of the applicable
pharmacopoeia to produce a solution free from microorganisms for the validated life of the filter.
2.23
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.
2.24
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.]
4 © ISO 2014 – All rights reserved

ISO 13959:2014(E)
2.25
user
physician or physician’s representative or healthcare professional with a responsibility for the
prescription, production, and delivery of dialysis fluid
2.26
water treatment system
collection of water treatment devices and associated piping, pumps, valves, gauges, etc., that together
produce water meeting the requirements of this International Standard for haemodialysis applications
and deliver it to the point of use
3 Dialysis water requirements
3.1 Dialysis water verification and monitoring
The quality of the dialysis water, as specified in 3.2 and 3.3, shall be verified upon installation of a water
treatment system. Monitoring of the dialysis water quality shall be carried out thereafter.
3.2 Microbiological requirements
Total viable microbial counts in dialysis water shall be less than 100 CFU/ml, or lower if required by
national legislation or regulations. An action level shall be set based on knowledge of the microbial
dynamics of the system. Typically, the action level will be 50 % of the maximum allowable level.
Endotoxin content in dialysis water shall be less than 0,25 EU/ml, or lower if required by national
legislation or regulations. An action level shall be set, typically at 50 % of the maximum allowable level.
NOTE See A.1 for a history of these requirements.
3.3 Chemical contaminants
Dialysis water shall not contain chemicals at concentrations in excess of those listed in Tables 1 and 2,
or as required by national legislation or regulations.
NOTE 1 See A.2 for an explanation of values supplied.
NOTE 2 The maximum allowable levels of contaminants listed in Tables 1 and 2 include the anticipated
uncertainty associated with the analytical methodologies listed in Table 3.
Where the dialysis water is used for the reprocessing of haemodialysers (cleaning, testing, and mixing
of disinfectants), the user is cautioned that the dialysis water shall meet the requirements of this
International Standard. The dialysis water should be measured at the input to the dialyser reprocessing
equipment.
ISO 13959:2014(E)
Table 1 — Maximum allowable levels of toxic chemicals and dialysis fluid electrolytes in
a
dialysis water
Maximum concentration
Contaminant
b
mg/l
Contaminants with documented toxicity in haemodialysis
Aluminium 0,01
Total chlorine 0,1
Copper 0,1
Fluoride 0,2
Lead 0,005
Nitrate (as N) 2
Sulfate 100
Zinc 0,1
Electrolytes normally included in dialysis fluid
Calcium 2 (0,05 mmol/l)
Magnesium 4 (0,15 mmol/l)
Potassium 8 (0,2 mmol/l)
Sodium 70 (3,0 mmol/l)
a
A dialysis facility’s Medical Director has the ultimate responsibility for ensuring the
quality of water used for dialysis.
b
Unless otherwise noted.
Table 2 — Maximum allowable levels of other trace elements in dialysis water
Maximum concentration
Contaminant
mg/l
Antimony 0,006
Arsenic 0,005
Barium 0,1
Beryllium 0,000 4
Cadmium 0,001
Chromium 0,014
Mercury 0,000 2
Selenium 0,09
Silver 0,005
Thallium 0,002
4 Tests for compliance with microbiological and chemical requirements
4.1 Microbiology of dialysis water
Samples shall be collected where a dialysis machine connects to the water distribution loop, from a
sample point in the distal segment of the loop or where such water enters a mixing tank.
Microbial analysis of water should be conducted as soon as possible after sample collection to avoid
unpredictable changes in the microbial population. If samples cannot be assayed within 4 h of collection,
follow the laboratory’s instructions for sample storage and shipping. Samples intended for colony counts
should not be frozen.
6 © ISO 2014 – All rights reserved

ISO 13959:2014(E)
Total viable counts (standard plate counts) shall be obtained using conventional microbiological assay
procedures (pour plate, spread plate, membrane filter techniques). Membrane filtration is the preferred
method for this test. Other methods may be used, provided that such methods have been appropriately
validated and compared to the cited methods. The calibrated loop technique is not accepted.
Culture media shall be tryptone glucose extract agar (TGEA), Reasoner’s 2A (R2A), or other media
that can be demonstrated to provided equivalent results. Blood or chocolate agar shall not be used.
Incubation temperatures of 17 °C to 23 °C and an incubation time of 168 h (7 d) are recommended. Other
incubation times and temperatures may be used if it can be demonstrated that they provide equivalent
results. No method will give a total microbial count.
The presence of endotoxins shall be determined by the Limulus amoebocyte lysate (LAL) test. Other test
methods may be used if it can be demonstrat
...