EN ISO 11609:2026

• Abstract:

  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 is applicable to dentifrices, including toothpastes, destined to be used by consumers on a daily basis with a toothbrush to promote oral hygiene.; This document does not apply to specific qualitative and quantitative requirements for freedom from biological and toxicological hazards. These are covered in ISO 7405 and ISO 10993-1.

• Status: Published
• Publication Date: 04-Aug-2026
• ICS: 71.100.70 - Cosmetics. Toiletries
• ICS: 97.170 - Body care equipment
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 05-Aug-2026
• Completion Date: 05-Aug-2026
• Ref Project: SIST EN ISO 11609:2026 - Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2026)

• Replaces: EN ISO 11609:2017 - Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)
• Effective Date: 18-Jan-2023
• Consolidated By: ISO 11609:2026 - Dentistry — Dentifrices — Requirements, test methods and marking
• Effective Date: 12-Feb-2026

Overview

EN ISO 11609:2026 – Dentistry – Dentifrices – Requirements, Test Methods and Marking (ISO 11609:2026) defines the international requirements for the physical and chemical properties, test methods, marking, labeling, and packaging of dentifrices, including common consumer products such as toothpastes. Developed by CEN and ISO Technical Committee 106/SC 7, this standard ensures that dentifrices used daily for oral hygiene with a toothbrush conform to rigorous safety and quality expectations. It is utilized by manufacturers, regulatory authorities, and product testers within the dental and cosmetics industries. EN ISO 11609:2026 does not address biological or toxicological assessments, which are covered under ISO 7405 and ISO 10993-1.

Key Topics

• Physical and Chemical Requirements:
  EN ISO 11609 specifies limits and test methods for key physical and chemical properties in dentifrice formulations, including:

  • Total fluoride concentration and content
  • Maximum allowable levels of heavy metals
  • Acceptable pH range (below 10.5)
  • Microbiology standards for product safety
  • Maximum abrasivity values for both dentine and enamel (using validated methods)
  • Requirements for product stability during shelf life
  • Exclusion of readily fermentable carbohydrates

• Test Methods:
  This standard describes standardized test procedures, such as:

  • pH measurement using specified suspension techniques and laboratory-grade water
  • Abrasivity assessment methods, including ADA-based protocols and surface profilometry
  • Stability tests simulating real-life storage and accelerated ageing conditions

• Marking and Labeling:
  To ensure traceability and consumer information, products must be clearly marked with:

  • Product name and manufacturer details
  • List of ingredients using INCI (International Nomenclature of Cosmetic Ingredients)
  • Fluoride content and type (if present)
  • Net content, expiry date, and safety notices (particularly relating to children and fluoride)
  • Production tracking code

• Packaging Requirements:
  Packaging must prevent contamination and preserve product quality throughout its shelf life, especially after exposure to handling, transport, and ageing conditions.

Applications

EN ISO 11609:2026 serves as a critical quality benchmark for organizations involved in the formulation, production, and distribution of consumer dentifrices, such as:

• Manufacturers:
  Ensuring that dentifrices meet consistency, safety, and efficacy standards, and providing reliable information for regulatory and market acceptance.

• Regulatory Bodies:
  Verifying that dental hygiene products comply with recognized international requirements for chemical composition, labeling, and safety.

• Quality Control Laboratories:
  Applying standard test methods for fluoride content, abrasivity, and formulation integrity during product development and batch testing.

• Retailers and Distributors:
  Selecting products that adhere to trusted international standards for safer consumer use and clear product labeling.

By following EN ISO 11609:2026, stakeholders contribute to safer, high-quality oral care products for everyday consumer use, support global harmonization, and facilitate access to multiple markets.

Related Standards

• ISO 7405: Evaluation of biocompatibility of dental materials (biological hazards)
• ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
• ISO 1942: Dentistry – Vocabulary
• ISO 3696: Water for analytical laboratory use – Specification and test methods
• ISO 19448: Dentistry – Analysis of fluoride concentration in aqueous solutions

These related standards provide additional requirements and guidance for chemical analysis, safety, and biological evaluation associated with dental products and materials. By integrating EN ISO 11609:2026 with these references, dental care manufacturers can ensure comprehensive product safety, regulatory compliance, and consumer trust.

SLOVENSKI STANDARD
01-oktober-2026
Nadomešča:
SIST EN ISO 11609:2017
Zobozdravstvo - Zobne paste - Zahteve, preskusne metode in označevanje (ISO
11609:2026)
Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2026)
Zahnheilkunde - Zahnreinigungsmittel - Anforderungen, Prüfverfahren und
Kennzeichnung (ISO 11609:2026)
Médecine bucco-dentaire - Dentifrices - Exigences, méthodes d’essai et marquage (ISO
11609:2026)
Ta slovenski standard je istoveten z: EN ISO 11609:2026
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11609
EUROPEAN STANDARD
NORME EUROPÉENNE
August 2026
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 11609:2017
English Version
Dentistry - Dentifrices - Requirements, test methods and
marking (ISO 11609:2026)
Médecine bucco-dentaire - Dentifrices - Exigences, Zahnheilkunde - Zahnreinigungsmittel -
méthodes d'essai et marquage (ISO 11609:2026) Anforderungen, Prüfverfahren und Kennzeichnung
(ISO 11609:2026)
This European Standard was approved by CEN on 22 May 2026.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11609:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11609:2026) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with 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 February 2027, and conflicting national standards
shall be withdrawn at the latest by February 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11609:2017.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11609:2026 has been approved by CEN as EN ISO 11609:2026 without any modification.

International
Standard
ISO 11609
Fourth edition
Dentistry — Dentifrices —
2026-07
Requirements, test methods and
marking
Médecine bucco-dentaire — Dentifrices — Exigences, méthodes
d’essai et marquage
Reference number
ISO 11609:2026(en) © ISO 2026
ISO 11609:2026(en)
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 11609:2026(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 (elemental impurities) .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 total fluoride in dentifrices .18
Bibliography .21

iii
ISO 11609:2026(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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 11609:2017), which has been technically
revised.
The main changes are as follows:
— edits and clarifications to align with the ISO directives;
— updates for abrasive availability;
— corrections for contacting the manufacturer of the cross-brushing machine;
— correcting Clause 2 and the Bibliography;
— 4.2 has been modified to suggest ISO 21392 for the analysis of five elemental impurities.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 11609:2026(en)
Introduction
Dentifrices are not expected to cause adverse reactions to oral soft tissue 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
conditions can be found through Reference [19], Reference [20] and Reference [21].

v
International Standard ISO 11609:2026(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 is applicable to dentifrices, including toothpastes, destined to be used by consumers on a
daily basis with a toothbrush to promote oral hygiene.
This document does not apply to specific qualitative and quantitative requirements for freedom from
biological and toxicological hazards. 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 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 8601-2, Date and time — Representations for information interchange — Part 2: Extensions
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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
dentifrice
substance or combination of substances specially prepared for 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.

ISO 11609:2026(en)
3.2
toothpaste
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 %. For an example method, see
Annex C.
Other validated methods of similar sensitivity and accuracy may be used (see References [22] to [31]).
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, e.g. school toothbrushing programmes.
4.2 Heavy metals (elemental impurities)
The total maximum concentration of heavy metals shall not exceed 20 mg/kg.
See ISO 21392 for antimony, arsenic, cadmium, lead or mercury and for other elemental impurities. The
methods described in References [32] and [33], or another validated method of similar sensitivity and
accuracy, may be used.
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. For some methods, see ISO 16212, ISO 18416,
ISO 21148, ISO 21149, ISO 21150, ISO 22717, ISO 22718 and ISO 29621 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 (see the procedure specified in Annex A or Annex B).

ISO 11609:2026(en)
The abrasivity of the dentifrice shall not exceed the following limit for enamel:
— 4,0 times that of the primary reference material (see the procedure specified in Annex A or Annex B).
NOTE Abrasivity values below the limits specified in this document 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. When
an alternative abrasivity reference to the primary reference material (calcium pyrophosphate) is used,
traceability to the primary reference material shall be maintained by the testing laboratory. When any
alternative abrasivity reference is used, the results shall be reported with respect to the original primary
reference material (calcium pyrophosphate).
4.6 Stability
The dentifrice shall show no deterioration that can affect conformity with this document or can 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. Conformity 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 in
accordance 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. One of the methods specified in
Annex A or Annex B may be used. Other validated measurement methods on dentine of similar sensitivity
and accuracy may be used. Conforming principles can be found in ISO 5725-1, ISO 5725-2, ISO 5725-3,
ISO 5725-4, ISO 5725-5, and ISO 5725-6. For other references, see, for example, References [34] and [35].
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. One of the methods specified in
Annex A or Annex B or another validated measurement method on enamel of similar sensitivity and accuracy
may be used. Principles can be found in ISO 5725-1, ISO 5725-2, ISO 5725-3, ISO 5725-4, ISO 5725-5, and
ISO 5725-6. For other references, see, for example, References [34] and [35].
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
storage at room temperature for 30 months, see Reference [36]. Following storage, test the product according
to this document.
ISO 11609:2026(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;
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 in accordance with ISO 8601-1 and ISO 8601-2, 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 conformity with this document, after being subjected to the ageing procedure
described in 5.4.
ISO 11609:2026(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
[37]
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 or composition that is well characterized and
2,3
its performance understood in the laboratory of choice may be used instead of calcium pyrophosphate.
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 recommended 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 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 the MEV 5
Series of cross-brushing machines. This information is given for the convenience of users of this document and does not
constitute an endorsement by ISO of this product.

ISO 11609:2026(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 37 MBq (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.
ISO 11609:2026(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 Polyamid 66 (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. The reference abrasive can 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) shall 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.
ISO 11609:2026(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 depends on 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 can 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.

ISO 11609:2026(en)
These samples are counted along with the test samples.
A.3.9.4.3 Calculation of correction factors
A.3.9.4.3.1 General
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.3.9.4.3.2 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.3.9.4.3.3 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 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
shall be weighed to an accuracy of 0,01 g.
A.3.9.4.3.4 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
ISO 11609:2026(en)
CC100
fmt
A  (A.3)
D
C
mr
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
CC10
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, expressed in g;
mr
G is the pre-net CPM per mass of slurry, expressed in g;
pre
G is the post-net CPM per mass of slurry, expressed in g.
post
100G
mt
A  (A.7)
D
G
mr
where
A is the dentine abrasivity;
D
G is the mean test dentifrice net CPM per mass of slurry, expressed in g;
mt
G is the mean reference net CPM per mass of slurry, expressed in g.
mr
ISO 11609:2026(en)
A.3.11.2 Enamel abrasivity
The enamel abrasivity, A , of the test dentifrices (or abrasives) is calculated as in Formulae (A.8) and (A.9):
E
GG
prepost
G  (A.8)
mr
where
G is the mean reference net CPM per mass of slurry, expressed in g;
mr
G is the pre-net CPM per mass of slurry, expressed in g;
pre
G is the post-net CPM per mass of slurry, expressed in g.
post
10G
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, expressed in g;
mt
G is the mean reference net CPM per mass of slurry, expressed in g.
mr
ISO 11609:2026(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
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 shall not be longer than the brush head. While measured specimen shall
lose contact with bristles of the brush, bristles shall 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 shall allow for easy removal of the slurry sample. It shall have some mechanism for the agitation of the
slurry while the brushing is taking place. This can 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 that 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
...