FprEN ISO 11609

SLOVENSKI STANDARD
oSIST prEN ISO 11609:2024
01-november-2024
Nadomešča:
SIST EN ISO 11609:2017
Zobozdravstvo - Zobne paste - Zahteve, preskusne metode in označevanje
(ISO/DIS 11609:2024)
Dentistry - Dentifrices - Requirements, test methods and marking (ISO/DIS 11609:2024)
Zahnheilkunde - Zahnreinigungsmittel - Anforderungen, Prüfverfahren und
Kennzeichnung (ISO/DIS 11609:2024)
Médecine bucco-dentaire - Dentifrices - Exigences, méthodes d’essai et marquage
(ISO/DIS 11609:2024)
Ta slovenski standard je istoveten z: prEN ISO 11609
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
oSIST prEN ISO 11609:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 11609:2024
oSIST prEN ISO 11609:2024
DRAFT
International
Standard
ISO/DIS 11609
ISO/TC 106/SC 7
Dentistry — Dentifrices —
Secretariat: JISC
Requirements, test methods and
Voting begins on:
marking
2024-09-19
Médecine bucco-dentaire — Dentifrices — Exigences, méthodes
Voting terminates on:
d'essai et marquage
2024-12-12
ICS: 97.170
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 11609:2024(en)
oSIST prEN ISO 11609:2024
DRAFT
ISO/DIS 11609:2024(en)
International
Standard
ISO/DIS 11609
ISO/TC 106/SC 7
Dentistry — Dentifrices —
Secretariat: JISC
Requirements, test methods and
Voting begins on:
marking
Médecine bucco-dentaire — Dentifrices — Exigences, méthodes
Voting terminates on:
d'essai et marquage
ICS: 97.170
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11609:2024(en)
ii
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
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 dentifrices . 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) A testing of total fluoride in dentifrices .18
Bibliography .21

iii
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
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 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 World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL:
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products.
This third edition cancels and replaces the second edition (ISO 11609:2010), which has been technically
revised.
iv
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
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 .

v
oSIST prEN ISO 11609:2024
oSIST prEN ISO 11609:2024
DRAFT International Standard ISO/DIS 11609:2024(en)
Dentistry — Dentifrices — Requirements, test methods
and marking
1 Scope
This document 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 document applies to dentifrices, including toothpastes, destined to be used by the consumers on a daily
basis with a toothbrush to promote oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological and toxicological hazards are
[1] [2]
not included in this document. These are covered in ISO 7405 and ISO 10993-1 .
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.
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
ISO 19448, Dentistry — Analysis of fluoride concentration in aqueous solutions by use of fluoride ion-selective
electrode
International Nomenclature of Cosmetic Ingredients (INCI), in International Cosmetic Ingredient Dictionary
1)
and Handbook
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at https:// www .electropedia .org/
— ISO Online browsing platform: available at https:// www .iso .org/ obp
3.1
dentifrice
any substance or combination of substances specially prepared for the consumers for hygiene of the
accessible surfaces of teeth and surrounding tissues
1) Nomenclature developed by the Personal Care Products Council (formerly CTFA). Available at: https:// access
.personalcarecouncil .org/ eweb/ DynamicPage .aspx ?Site = pcpc & WebKey = 4513b14e -2f75 -4857 -85b4 -b3697be5d5d9.

oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
3.2
toothpaste
any semi-solid dentifrice preparation presented in the form of a paste, cream or gel
Note 1 to entry: The product’s common constituents are abrasives, humectants, binders, surfactants, flavourings,
fluorides and other agents for oral health benefits.
3.3
single-unit container
container of dentifrice marketed to individual consumers
3.4
primary container
container that is in direct contact with the product
4 Requirements relative to the physical and chemical properties of dentifrices
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 professionally supervised
conditions or in community-based caries prevention programmes such as school toothbrushing programmes.
4.2 Heavy metals
The total maximum concentration of heavy metals 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 limit for dentine:
— 2,5 times that of the primary reference material, if using the procedure specified in Annex A or B;
The abrasivity of the dentifrice shall not exceed the following limit for enamel:
— four times that of the primary reference material, if using the procedure specified in Annex A or B.

oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
NOTE Abrasivity values below the limits specified in this standard are not intended to be used to rank the safety
of dentifrices. All dentifrices beneath the abrasivity limits are recognized as safe with respect to their abrasion of
human hard tissues.
Test in accordance with 5.2 or 5.3 or any other validated method of similar sensitivity and accuracy.
NOTE If an alternative abrasivity reference to the primary reference material (calcium pyrophosphate) is used,
traceability to the primary reference material must be maintained by the testing laboratory. Results must always be
reported with respect to the original primary reference material (calcium pyrophosphate) if any alternative abrasivity
reference is used.
4.6 Stability
The dentifrice shall show no deterioration that may affect compliance with this document or could result
in toxicological hazards 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,
[39] [44]
conforming to practices and principles found in References to. For other references 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,
[39] [44]
conforming to practices and principles found in References to. For other references 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 3 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
document.
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
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 6 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 document, after being subjected to the ageing procedure
described in 5.4.
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
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 . Other validated methods of similar or better sensitivity and accuracy may also be used.
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
3)
reference abrasive , or another well characterized material / composition that is well characterized and its
2),3)
performance understood in the laboratory of choice may be used instead of calcium phosphate. For the
[30]
procedure specified in BS 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 (approximately 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.
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
2) Reference calcium pyrophosphate was historically available from Odontex Inc. For more information contact ADA/
ANSI standards. This information is given for the convenience of users of this document and does not constitute an
endorsement by ISO of this product.
3) One alternative reference silica is available from Evonik, Rodenbacher Chaussee 4, 63457 Hanau Wolfgang, Germany.
This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of
this product.
4) One acceptable product is available from ODEME, odeme@odeme .com .br; https:// www .odeme .com .br/ ingles/
produtos _selecionado .php ?id _produto = 221 This information is given for the convenience of users of this document and
does not constitute an endorsement by ISO of this product.

oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
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 is 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 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
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 4 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 depend 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.
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.
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
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
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
5)
The diluent is a 0,5 % carboxymethyl cellulose (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 (see
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.
A.3.7 Dentifrice slurries
To prepare the test slurries, add 40 ml of water to 25 g of each dentifrice. For the machine, prepare eight
slurries of each dentifrice. This dilution produces a final slurry volume and concentration similar to those of
the reference abrasive slurry. All slurries (reference and test) should be used shortly after preparation and
after vigorous mechanical stirring to prevent particles from settling.
A.3.8 Preconditioning of tooth specimens
A.3.8.1 Dentine
To reduce the variation caused by dentine surface differences, precondition the specimens prior to each use.
The preconditioning treatment consists of brushing with a slurry of the reference abrasive but not taking
a sample. The first time dentine specimens are used, the preconditioning should be for 6 000 strokes. Each
successive daily run should begin with a shorter preconditioning brushing of 1 000 strokes. The tension of
the toothbrush on the roots shall be 150 g.
5) An acceptable CMC is available from Hercules Incorporated, Aqualon Division, 1111 Hercules Road, Hopewell, VA 23860,
USA, http:// www .ashland .com/ industries/ pharmaceutical/ oral -solid -dose/ aqualon -sodium -ca rboxymethylcellulose.
This information is given for the convenience of users of this document and does not constitute an endorsement by ISO of
this product.
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
Discard the preconditioning slurries.
A.3.8.2 Enamel
Preconditioning of the enamel is similar to that of the dentine, except that 10 000 strokes are used prior to
the first use and 1 000 strokes are given at the beginning of each day.
Discard the preconditioning slurries.
A.3.9 Test design
A.3.9.1 Test design for dentine
The test design may be either a sandwich design or a Latin Square design. The sandwich design is such that
a set of reference slurries is run (pre-test), followed by a set of the first test slurries. These are followed by
a second set of reference slurries (post-test). This second set of reference slurries then acts as the pre-test
slurries for the next test group. This continues until all the test groups are run.
The Latin Square design is such that a set of reference slurries is run first. All the test groups are randomized
over the eight brushing heads for the next few runs (depending on the number of test groups). Then a post-
test reference set of slurries is run as the final procedure.
In both test designs, the brush tension is set at 150 g and brushing is performed for 1 500 to 3 000 strokes,
depending on the radioactivity level of the specimens.
A.3.9.2 Test design for enamel
The test design for enamel is identical to that for dentine, except that the number of strokes is 5 000 to 7 500
depending on the activity of the specimens.
A.3.9.3 Sampling of slurries
The sampling of the slurries following the brushing is identical for both dentine and enamel. An aliquot
of each slurry is removed immediately following brushing. The size of the aliquot will depend upon the
counting method and equipment, but 3 ml is usually adequate to provide a detectable level of radioactivity.
A convenient method for removing the sample is a syringe fitted with a blunt needle. Take care to ensure
there is no carry-over between samples. This can best be done by a complete rinsing of the syringe between
samples. It is also important to remove the same quantity of sample from each slurry. Dry the sample if a
planchet counter system is being used to detect the radioactivity. If drying is needed, the samples should be
air-dried for a least 1 h and then dried in an oven at 60 °C with forced air overnight.
A.3.9.4 Correction factors
A.3.9.4.1 General
Correction factors are needed for both dentine and enamel abrasion tests when using the planchet counting
method and are identically prepared in both methods. When testing dentifrices with abrasive systems
different from the reference material, the self-absorption and backscattering characteristics of the abrasives
for beta radiation may also differ. Real differences in abrasivity may then be significantly distorted. The
correction factor is a means of reducing this variable. The correction factor is determined in different ways
depending on the counting method used.
A.3.9.4.2 Preparation of correction factor slurries for Geiger-Müller planchet counting
Dissolve one piece of irradiated dentine (or enamel) in 5 ml of concentrated HCl. Transfer the solution to a
250 ml volumetric flask and add water to the mark. Add 1,0 ml of this radioactive solution to slurries of the
reference abrasive and to each of the test abrasives prepared in the same manner as in the test. To neutralize
the acid, add 1,0 ml of 0,5 mol/l NaOH. Mix the slurries thoroughly, sample, and dry the samples along with
those from the test runs. Do not brush with these correction factor slurries.

oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
These samples are counted along with the test samples.
A.3.9.4.3 Calculation of correction factors
The correction factor, C , to be applied to all count values of the test sample is calculated as in Formula (A.1):
f
C
r
C = (A.1)
f
C
t
where
C is the mean counts for four reference samples;
r
C is the mean counts for four test samples.
t
A.3.9.4.3.1 Correction factors for liquid scintillation counting
The correction is determined with regard to the amount of sample mixed with the scintillation cocktail.
Each sample is weighed and the net count per minute (CPM) is divided by the mass to get a net CPM per gram
of slurry. These net CPM-per-gram values are then used in calculating abrasivity in place of net CPM values
according to A.3.11, and there is no C term.
f
A.3.9.4.3.2 Correction factors for liquid scintillation detection
Self-absorption and backscatter are less of a concern because of the liquid medium being used. Most modern
liquid scintillation equipment will automatically colour-correct, so this is not a problem. The differences
in mass of the samples do need to be accounted for in the calculation. To do this, each sample taken after
brushing needs to be weighed to an accuracy of 0,01 g.
A.3.9.4.3.3 Applying the correction factor
Before calculating the relative abrasion values, the net CPM of each slurry is divided by the mass of the
slurry used to get a net CPM per gram of slurry. These values are then used in the calculation of relative
abrasive values.
A.3.10 Calculation of abrasivity using Geiger-Müller counting
A.3.10.1 Dentine abrasivity
The dentine abrasivity, A , of the test dentifrices (or abrasives) is calculated as in Formulae (A.2) and (A.3):
D
CC+
prepost
C = (A.2)
mr
where
C is the mean reference net CPM;
mr
C is the pre-net CPM;
pre
C is the post-net CPM.
post
CC××100
fmt
A = (A.3)
D
C
mr
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
where
A is the dentine abrasivity;
D
C is the correction factor;
f
C is the mean test dentifrice net CPM;
mt
C is the mean reference net CPM.
mr
A.3.10.2 Enamel abrasivity
The enamel abrasivity, A , of the test dentifrices (or abrasives) is calculated as in Formulae (A.4) and (A.5):
E
CC+
prepost
C = (A.4)
mr
where
C is the mean reference net CPM;
mr
C is the pre-net CPM;
pre
C is the post-net CPM.
post
CC××10
fmt
A = (A.5)
E
C
mr
where
A is the enamel abrasivity;
E
C is the correction factor;
f
C is the mean test dentifrice net CPM;
mt
C is the mean reference net CPM.
mr
A.3.11 Calculation of abrasivity using liquid scintillation
A.3.11.1 Dentine abrasivity
The dentine abrasivity, A , of the test dentifrices (or abrasives) is calculated as in Formulae (A.6) and (A.7):
D
GG+
prepost
G = (A.6)
mr
where
G is the mean reference net CPM per mass of slurry, in grams;
mr
G is the pre-net CPM per mass of slurry, in grams;
pre
G is the post-net CPM per mass of slurry, in grams.
post
100×G
mt
A = (A.7)
D
G
mr
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
where
A is the dentine abrasivity;
D
G is the mean test dentifrice net CPM per mass of slurry, in grams;
mt
G is the mean reference net CPM per mass of slurry, in grams.
mr
A.3.11.2 Enamel abrasivity
The enamel abrasivity of the test dentifrices (or abrasives) is calculated as in Formulae (A.8) and (A.9):
GG×
prepost
G = (A.8)
mr
where
G is the mean reference net CPM per mass of slurry, in grams;
mr
G is the pre-net CPM per mass of slurry, in grams;
pre
G is the post-net CPM per mass of slurry, in grams.
post
10×G
mt
A = (A.9)
E
G
mr
where
A is the enamel abrasivity;
E
G is the mean test dentifrice net CPM per mass of slurry, in grams;
mt
G is the mean reference net CPM per mass of slurry, in grams.
mr
oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
Annex B
(informative)
Determination of relative dentifrice abrasivity to enamel and dentine
by a surface profile method
B.1 General
This method is based on the determination of abraded depth after brushing, using profilometry. This
method has been established to be equivalent to the radio-tracer method (see Annex A) and will be referred
to as RDA-PE (Relative Dentin Abrasion – Profilometry Equivalent) and REA-PE (Relative Enamel Abrasion
– Profilometry Equivalent). Other validated methods of similar or better sensitivity and accuracy may also
be used.
B.2 Apparatus
B.2.1 Contact profilometer, or a similar instrument with a sensitivity to <0,1 μm [e.g. Talyform i50,
6)
Surfometer or Surftest SV-2000 ], or a non-contact profilometer, or a similar instrument with a sensitivity
7)
to <0,1 μm [e.g. Bruker GT-K1 ].
8)
B.2.2 Lapping and polishing unit [e.g. Abramin automatic lapping and polishing unit ], with sequential
silicon carbide discs up to P1200 and ability to use diamond slurries for specimen polishing and/or their
equivalent.
NOTE Other methods of polishing enamel and dentine to conform with the baseline requirements for specimens
can be used (e.g. diamond powder).
B.2.3 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. While measured specimen must lose the
contact with bristles of the brush, bristles should not lose the contact with the mounting material, i.e. dental
acrylic. 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. It could be accomplished by rubber mixing vanes just below the
brush head, metal stirrers, or plungers that prevent the abrasive from settling to the bottom of the slurry
container.
NOTE Some machines have less than eight specimen positions, but can be used provided the n value for specimens/
treatment is reached.
6) Talyform i50 is the trade name for a product supplied by Taylor Hobson Ltd., Leicester, UK; and Surfometer is the
trade name for a product supplied by Planar Products Ltd., Sunbury on Thames, UK; and Surftest SV-2000 is the trade
name for a product supplied by Mitutoyo, Andover, UK. This information is given for the convenience of users of this
document and does not constitute an endorsement by ISO of this product.
7) Bruker GT-K1 is the trade name for a product supplied by Bruker Co., Billerica, MA, USA. This information is given for
the convenience of users of this document and does not constitute an endorsement by ISO of this product.
8) Abramin is the trade name for a product supplied by Struers Ap.S, Denmark. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO of this product.

oSIST prEN ISO 11609:2024
ISO/DIS 11609:2024(en)
B.2.4 Manual toothbrush.
Keep brushes consistent. At a minimum, do not vary within a test the manufacturer, source, type (same
brand/version), and age within any one experiment. Suitable brushes have been found to have bristles made
of nylon, bristles having a uniform diameter of 200 μm and a uniform overall length of 11 mm, as measured
from the face of the toothbrush. Bristles should be grouped in tufts of approximately 18 to 22 bristles per
tuft, 38 tufts per toothbrush in 12 rows of tufts, with rows ranging from one tuft to four tufts per row, no
tuft more than 2 mm from its nearest neighbour, and tufts occurring within a row substantially symmetric
from the left to right side of the brush head. The bristles shall be no more than ±200 μm differential at the
flat surface. See A.3.4 for an example of a suitable brush.
B.2.5 Standard reference abrasive as detailed in A.3.1, being either pyrophosphate or silica abrasives.
B.3 Preparation of enamel and dentine specimens
B.3.1 Use human caries-free, erupted or un-erupted permanent teeth or bovine teeth that can produce
specimens of required size.
NOTE Human lower incisors may be unsuitable because of their small size.
B.3.2 Remove all soft tissue remnants by scraping with a suitable instrument (e.g. curette, scalpel, etc.),
sterilize and store the teeth with 0,1 % thymol or other neutralized solution that disinfects but does not
alter the physical properties of the tooth.
B.3.3 Section the teeth at the amelo-cemental junction with a dental bur or disc. Use the coronal portion
for enamel specimens and the radicular portion for dentine specimens resulting in the size of the specimen
to be no less than 3 mm × 5 mm × 3 mm.
NOTE Depending on the size and morphology of the crown and roots, it may be possible to prepare two specimens
from each, but no more than two/tooth.
B.3.4 For enamel, section the molar crown vertically in either a bucco-lingual or a mesio-distal direction
resulting in two enamel specimens/crowns. For dentine, section the root portion vertically in half, so that an
outer portion of root surface is available for polishing. If using bovine specimens that are larger than human
specimens, you can se
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