SIST EN ISO 11609:2010
(Main)Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2010)
Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2010)
This International Standard specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and packaging of dentifrices. This International Standard applies to dentifrices, including toothpastes, destined to be used by the public on a daily basis with a toothbrush to promote oral hygiene. Specific qualitative and quantitative requirements for freedom from biological and toxicological hazards are not included in this International Standard.
Zahnheilkunde - Zahnpasten - Anforderungen, Prüfverfahren und Kennzeichnung (ISO 11609:2010)
Diese Internationale Norm legt Anforderungen und Prüfverfahren für die physikalischen und chemischen Eigenschaften sowie die Kennzeichnung und/oder Etikettierung von Zahnpasten, einschließlich Zahnpasten für den täglichen Gebrauch mittels einer Zahnbürste zur Verbesserung der Mundhygiene der Allgemeinheit fest. ANMERKUNG 1 Anleitungen zur Bewertung der angegebenen bzw. implizierten Wirksamkeit von Zahnpasten zur Vorbeugung oder Kontrolle oraler Erkrankungen sind zu finden in FDI Commission Work Project (8-95), eine Anleitung zur Bewertung der Wirksamkeit von Zahnpasta ist enthalten in International Dental Journal, 49, 1999, S. 311-316, oder in den
Verweisungen [18, 19].
Art dentaire - Dentifrices - Exigences, méthodes d'essai et marquage (ISO 11609:2010)
L'ISO 11609:2010 spécifie des exigences relatives aux propriétés physiques et chimiques des dentifrices, et donne des recommandations concernant les méthodes d'essai. Elle spécifie également des exigences relatives au marquage, à l'étiquetage et à l'emballage des dentifrices.
L'ISO 11609:2010 est applicable aux dentifrices, y compris les pâtes dentifrices, destinés à être utilisés quotidiennement par le grand public avec une brosse à dents, dans le but de favoriser l'hygiène buccale.
Zobozdravstvo - Zobne paste - Zahteve, preskusne metode in označevanje (ISO 11609:2010)
Ta mednarodni standard določa zahteve za fizične in kemijske lastnosti zobnih past in zagotavlja smernice za ustrezne preskusne metode. Prav tako določa zahteve za označevanje, etiketiranje in pakiranje zobnih past. Ta mednarodni standard velja za zobne paste, vključno z zobnimi pastami, namenjenimi za vsakodnevno javno uporabo z zobno ščetko, za promocijo ustne higiene. Posebne kakovostne in količinske zahteve za odsotnost bioloških in toksikoloških nevarnostmi niso zajete v tem mednarodnem standardu.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11609:2010
01-november-2010
1DGRPHãþD
SIST EN ISO 11609:2000
=RER]GUDYVWYR=REQHSDVWH=DKWHYHSUHVNXVQHPHWRGHLQR]QDþHYDQMH ,62
Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2010)
Zahnheilkunde - Zahnpasten - Anforderungen, Prüfverfahren und Kennzeichnung (ISO
11609:2010)
Art dentaire - Dentifrices - Exigences, méthodes d'essai et marquage (ISO 11609:2010)
Ta slovenski standard je istoveten z: EN ISO 11609:2010
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 11609:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11609:2010
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SIST EN ISO 11609:2010
EUROPEAN STANDARD
EN ISO 11609
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2010
ICS 97.170 Supersedes EN ISO 11609:1998
English Version
Dentistry - Dentifrices - Requirements, test methods and
marking (ISO 11609:2010)
Médecine bucco-dentaire - Dentifrices - Exigences, Zahnheilkunde - Zahnputzmittel - Anforderungen,
méthodes d'essai et marquage (ISO 11609:2010) Prüfverfahren und Kennzeichnung (ISO 11609:2010)
This European Standard was approved by CEN on 31 August 2010.
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 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11609:2010: E
worldwide for CEN national Members.
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SIST EN ISO 11609:2010
EN ISO 11609:2010 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11609:2010
EN ISO 11609:2010 (E)
Foreword
The text of ISO 11609:2010 has been prepared by Technical Committee ISO/TC 106 "Dentistry" of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 11609:2010 by
Technical Committee CEN/TC 55 “Dentistry” 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 March 2011, and conflicting national standards shall be withdrawn at
the latest by March 2011.
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 supersedes EN ISO 11609:1998.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11609:2010 has been approved by CEN as a EN ISO 11609:2010 without any modification.
3
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SIST EN ISO 11609:2010
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SIST EN ISO 11609:2010
INTERNATIONAL ISO
STANDARD 11609
Second edition
2010-09-01
Dentistry — Dentifrices — Requirements,
test methods and marking
Médecine bucco-dentaire — Dentifrices — Exigences, méthodes
d'essai et marquage
Reference number
ISO 11609:2010(E)
©
ISO 2010
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Requirements relative to the physical and chemical properties of dentifices.2
4.1 Total fluoride.2
4.1.1 Total fluoride concentration.2
4.1.2 Total fluoride in a single-unit container.2
4.2 Heavy metals.2
4.3 pH.2
4.4 Microbiology .2
4.5 Abrasivity .2
4.6 Stability.3
4.7 Readily fermentable carbohydrates .3
5 Test methods .3
5.1 Determination of pH .3
5.2 Determination of dentine abrasivity .3
5.3 Determination of enamel abrasivity.3
5.4 Determination of stability .3
6 Marking and labelling.4
7 Packaging.4
Annex A (informative) Abrasivity test procedure — American Dental Association (ADA) method .5
Annex B (informative) Determination of relative dentifrice abrasivity to enamel and dentine by a
surface profile method.12
Annex C (informative) Testing of total fluoride in dentifrices .16
Bibliography.19
© ISO 2010 – All rights reserved iii
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11609 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products.
This second edition of ISO 11609 cancels and replaces the first edition (ISO 11609:1995), which has been
technically revised.
iv © ISO 2010 – All rights reserved
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
Introduction
Dentifrices should not cause any adverse reactions to the oral soft tissues when used in accordance with the
manufacturer's recommendation for frequency and duration of use, nor cause any known side effects.
Guidelines on assessing the claimed or implied efficacy of dentifrices for the prevention or control of oral
[3] [4]
conditions can be found through the US Food and Drug Administration , the American Dental Association
[16]
and the Commission Work Project (8-95) of the FDI World Dental Federation .
© ISO 2010 – All rights reserved v
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SIST EN ISO 11609:2010
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SIST EN ISO 11609:2010
INTERNATIONAL STANDARD ISO 11609:2010(E)
Dentistry — Dentifrices — Requirements, test methods and
marking
1 Scope
This International Standard specifies requirements for the physical and chemical properties of dentifrices and
provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and
packaging of dentifrices.
This International Standard applies to dentifrices, including toothpastes, destined to be used by the public on a
daily basis with a toothbrush to promote oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological and toxicological hazards are not
[1] [2]
included in this International Standard. These are covered in ISO 7405 and ISO 10993-1 .
2 Normative references
The following referenced documents are indispensable for the application 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.
ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
International Nomenclature of Cosmetic Ingredients (INCI), in International Cosmetic Ingredient Dictionary and
1)
Handbook
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
dentifrice
any substance or combination of substances specially prepared for the public for hygiene of the accessible
surfaces of teeth and surrounding tissues
3.2
toothpaste
any semi-solid dentifrice preparation presented in the form of a paste, cream or gel
NOTE The products' common constituents are abrasives, humectants, binders, surfactants, flavourings, fluorides and
other agents for oral health benefits.
1) Nomenclature developed by the Personal Care Products Council (Formerly CTFA). Available at:
http://www.ctfa.org/council-bookstore.
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
3.3
single-unit container
container of dentifrice marketed to individual consumers
3.4
primary container
container that is in contact with the product
4 Requirements relative to the physical and chemical properties of dentifices
4.1 Total fluoride
4.1.1 Total fluoride concentration
The total fluoride concentration shall not exceed a mass fraction of 0,15 % when tested in accordance with
one of the procedures given in Annex C.
Other validated methods of similar sensitivity and accuracy may be used (see References [5] to [12], [28] and
[29]).
4.1.2 Total fluoride in a single-unit container
The amount of total fluoride in a single-unit container shall not exceed 300 mg.
This requirement does not apply to containers of dentifrice to be dispensed under supervised conditions in
community-based caries prevention programmes such as school tooth brushing programmes.
4.2 Heavy metals
The total maximum concentration shall not exceed 20 mg/kg.
Test in accordance with References [13], [14] or [15], or another validated method of similar sensitivity and
accuracy.
4.3 pH
When tested in accordance with 5.1, the dentifrice shall have a pH below 10,5.
4.4 Microbiology
Testing for microbiological contamination shall be carried out according to References [17] to [22] and [31] to
[38] or any other validated method of equivalent sensitivity, accuracy and specificity.
4.5 Abrasivity
The abrasivity of the dentifrice shall not exceed the following limits for dentine:
⎯ 2,5 times that of the primary reference material, if using the procedure specified in Annex A; or
⎯ 2 times that of the primary reference material, if using the procedures specified in Annex B.
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
The abrasivity of the dentifrice shall not exceed the following limits for enamel:
⎯ 4 times that of the primary reference material, if using the procedure specified in Annex A; or
⎯ 4 times that of the primary reference material, if using the procedures specified in Annex B.
Test in accordance with 5.2 or 5.3 or any other validated method of similar sensitivity and accuracy.
4.6 Stability
The dentifrice shall show no deterioration that may affect compliance with this International Standard after
being subjected to one of the ageing procedures specified in 5.4 or after 30 months of storage at room
temperature. If deterioration is detected, the dentifrice shall be labelled with an expiry date.
4.7 Readily fermentable carbohydrates
The dentifrice shall not contain readily fermentable carbohydrates. Compliance shall be established by the
absence of such compounds in the complete formula or by performing tests in accordance with commonly
used analytical methods.
5 Test methods
5.1 Determination of pH
Suspend one part by mass of the dentifrice into three parts by mass of water for analytical laboratory use
complying with ISO 3696 (grade 3). Determine the pH of the suspension within 10 min, using a pH-meter and
electrode assembly.
5.2 Determination of dentine abrasivity
Determine the mean relative abrasivity compared to the primary reference sample, or any other reference
material calibrated to the primary reference sample for human dentine, using one of the methods specified in
Annex A or B.
Other validated measurement methods on dentine of similar sensitivity and accuracy may be used; see for
example References [23] and [24].
5.3 Determination of enamel abrasivity
Determine the mean relative abrasivity compared to the primary reference sample, or any other reference
material calibrated to the primary reference sample for human enamel, using one of the methods specified in
Annex A or B.
Other validated measurement methods on enamel of similar sensitivity and accuracy may be used; see for
example References [23] and [24].
5.4 Determination of stability
For the accelerated ageing procedure, the dentifrice shall be stored in its original container at 40 °C ± 2 °C at
75 % ± 5 % relative humidity for three months or at such conditions of time and temperature as will simulate
[25]
storage at room temperature for 30 months . Following storage, test the product according to this
International Standard.
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
6 Marking and labelling
With the exception of small single units (less than 10 ml), all primary containers shall be marked with the
following information:
a) the word “dentifrice” or equivalent (see Clause 3);
b) the trade name;
c) the name and contact information of the manufacturer or responsible distributor;
d) the tracking code that includes an intelligible production date;
e) a complete list of ingredients according to the International Nomenclature of Cosmetic Ingredients (INCI);
f) the concentration and type of fluoride, if present, expressed in micrograms per gram, or percent by mass,
or both;
g) the net volume, in millilitres, or net mass in grams, or both;
h) the expiry date, expressed according to ISO 8601, if the period of stability (shelf-life) is less than
30 months;
i) a safety notice regarding the use, by children below six years of age, of dentifrices containing
concentrations of fluoride of 1 000 µg/g or more.
7 Packaging
The product shall be packaged in such a way that under normal conditions of handling and transport, the
container or dispensing system, or both, shall not contaminate or permit contamination of the dentifrice inside,
so as to affect its compliance with this International Standard, after being subjected to the ageing procedure
described in 5.4.
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
Annex A
(informative)
Abrasivity test procedure — American Dental Association (ADA) method
A.1 General
This annex identifies the specific procedures for determination of the dentifrice abrasivity using the ADA
[26]
laboratory method .
A.2 Sampling
A representative sample shall be taken from at least two batches.
A.3 Procedure
A.3.1 Standard reference abrasive
2)
The primary reference abrasive is from a specific lot of calcium pyrophosphate . An alternate, silica reference
3) [27] [30]
abrasive is also available . For the procedure specified in BSI 5136 , a chalk reference dentifrice is also
available.
A.3.2 Apparatus
A.3.2.1 Brushing machine
4)
A cross-brushing machine is the apparatus of choice . The apparatus should have eight positions for holding
specimens. A toothbrush shall be positioned to pass reciprocally at a small angle (≈ 5°) over the mounted
specimens, with a designated tension on the brush, while immersed in a dentifrice slurry. The distance
traversed by the brush should not be longer than the brush head so that the specimen does not lose contact
with the brush. The mechanism for holding the dentifrice slurry may vary with different machine designs, but
should allow for easy removal of the slurry sample. It is important to have some mechanism for the agitation of
the slurry while the brushing is taking place. A convenient method to accomplish this is to attach rubber mixing
vanes just below the brush head. As the brushing takes place, these vanes will prevent the abrasive from
settling to the bottom of the slurry container.
2) Reference calcium pyrophosphate is available from Odontex Inc., 3030 Campfire Dr., Lawrence, KS 66049, USA,
http://www.odontexusa.com. This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO of this product.
3) Alternate reference silica (Sident®) is available from Evonik, Rodenbacher Chaussee 4, 63457 Hanau Wolfgang,
Germany, Arnold.Storeck@EVONIK.com. This information is given for the convenience of users of this document and
does not constitute an endorsement by ISO of this product.
4) An acceptable product is available from Sabri Dental Enterprises, Inc., 1404 Brooke Dr., Downers Grove, IL 60515,
USA, http://www.sabridentalresearch.com. This information is given for the convenience of users of this document and
does not constitute an endorsement by ISO of this product.
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
A.3.2.2 Radioactivity detector
The two recommended methods for the determination of the radioactivity of the used dentifrice slurries are a
Geiger-Müller planchet counter and a liquid scintillation detector. The use of the Geiger counter requires that
the samples be dried under defined controlled conditions. The liquid scintillation method has the advantage of
reading directly from the slurry.
Counting should be done for a period expected to reduce the alpha value for counting error to less than 2 %.
Counting should be performed for a minimum of 1 000 counts and for at least 1 min. The number of brushing
strokes may be increased if counting times become too long.
A.3.3 Preparation of tooth specimens
A.3.3.1 Dentine specimens
A.3.3.1.1 Selection
Human root dentine of extracted permanent teeth are used as the substrate. Single-rooted teeth that were
vital at extraction should be selected. An exception, because of the small size, are mandibular incisors: these
should not be used. The specimen should be at least 14 mm long and 2 mm wide at the narrow end. All roots
shall be caries-free and free of anatomical defects. After extraction, the roots should be stored in a neutralized
solution that disinfects but does not alter the physical properties.
A.3.3.1.2 Preparation
Scrape the roots clean of all soft tissue and as much cementum as possible. Then remove the crown and the
root tips using a separating disc under a flow of water.
A.3.3.1.3 Irradiation
For each set of eight specimens to be irradiated, add one or two extra roots for use in correction factors. Pack
the specimens in disinfection solution and submit to a nuclear reactor for irradiation. The neutron flux should
32
be sufficient to produce about 1 mCi of P beta radiation after several hours. Elevated temperatures in the
reactor (above 65 °C) should be avoided. A specific position shall be requested to shield the samples from
fast neutrons and gamma radiation. Handling of the irradiated specimens should be done with care using
good laboratory practice. The specimens should not be used during the first half-life because of excess
32
radiation and should be used before the end of the third half-life because of lack of activity. The half-life of P
is 14,3 days so the usable life span of a set of teeth is four weeks.
A.3.3.1.4 Mounting of specimens
Mount the specimens individually in a mould in cold-cure methyl methacrylate resin such that either the buccal
or lingual surface protrudes at least 2 mm above and parallel to the resin. Orient the mould in the brushing
machine such that the direction of brushing is perpendicular to the long dimension of the root. Store the
mounted specimens in a neutralized solution that disinfects but does not alter the physical properties.
NOTE The type and configuration of the mould depends on the holder of the brushing machine.
A.3.3.2 Enamel specimens
A.3.3.2.1 Selection
Selection criteria for enamel specimens are the same as for dentine. The enamel specimens should be
obtained from human maxillary incisors.
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SIST EN ISO 11609:2010
ISO 11609:2010(E)
A.3.3.2.2 Preparation
The entire labial surface of the specimen is used after removing the root. Clean the enamel in the same way
as the root.
A.3.3.2.3 Irradiation
Irradiation of the enamel is identical to the method used with the roots. The roots and enamel specimens may
be packed together for submission to the reactor.
A.3.3.2.4 Mounting
Mount the enamel specimens in the same way as the roots. The labial surface shall protrude 2 mm and be
parallel to the resin surface.
A.3.4 Toothbrushes
5)
The toothbrushes used should have nylon filaments about 10 mm in length. Filament ends should lie in a
plane.
Store the brushes in water overnight prior to their first use and then keep them in water until they are
discarded. Use a new set of brushes for each set of teeth. Do not remove the brushes from the machine
between runs but raise the tufts off the specimen so as not to bend the bristles. At the beginning of each run,
set the tension of the brush on the specimen to 150 g using a Chatillon spring gauge or equivalent. This
tension should be rechecked at least twice daily. The method of adjusting the tension will vary depending
upon the type of mechanism on the brushing machine.
A.3.5 Reference diluent
6)
The diluent is a 0,5 % carboxymethylcellulose (7MF CMC) solution in 10 % glycerine. To prepare 1 l of the
diluent, heat 50 ml of glycerine to 60 °C and add 5 g of CMC while stirring. When the mixture is
homogeneous, add another 50 ml of heated glycerine and continue stirring for 60 min. Transfer the solution to
a 1 l flask and add 900 ml of distilled water. Allow to cool but continue stirring slowly overnight. To stabilize the
viscosity, allow the solution to stand overnight before using. This solution is used to make up slurries of the
reference abrasive or any powder being tested.
A.3.6 Reference abrasive slurry
Using the reference material described in A.3.1, dilute 10 g of the abrasive with 50 ml of the diluent (A.3.5).
The same ratio is used for all powders. It is possible for the reference abrasive to be used as a dentifrice. If
this is the case, it shall be made up as a 40 % abrasive dentifrice with the rest of the constituents being
conventional dentifrice components. The slurry is then made using 25 g of reference dentifrice and 40 ml of
water.
5) Acceptable toothbrushes are available from Odontex Inc., 3030 Campfire Dr., Lawrence, KS 66049, USA,
info@Odontexusa.com. This information is given for the convenience of users of this document and does not constitute an
endorsement by ISO of this product.
6) An acceptable CMC is available from Hercules Incorporated, Aqualon Division, 1111 Hercules
...
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