EN ISO 11609:2017

SLOVENSKI STANDARD
01-september-2017
1DGRPHãþD
SIST EN ISO 11609:2010
=RER]GUDYVWYR=REQHSDVWH=DKWHYHSUHVNXVQHPHWRGHLQR]QDþHYDQMH,62

Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)
Zahnheilkunde - Zahnreinigungsmittel - Anforderungen, Prüfverfahren und
Kennzeichnung (ISO 11609:2017)
Médecine bucco-dentaire - Dentifrices - Exigences, méthodes d'essai et marquage (ISO
11609:2017)
Ta slovenski standard je istoveten z: EN ISO 11609:2017
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11609
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2017
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 11609:2010
English Version
Dentistry - Dentifrices - Requirements, test methods and
marking (ISO 11609:2017)
Médecine bucco-dentaire - Dentifrices - Exigences, Zahnheilkunde - Zahnreinigungsmittel -
méthodes d'essai et marquage (ISO 11609:2017) Anforderungen, Prüfverfahren und Kennzeichnung
(ISO 11609:2017)
This European Standard was approved by CEN on 12 June 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11609:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11609:2017) 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 December 2017 and conflicting national standards
shall be withdrawn at the latest by December 2017.
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 11609:2010.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11609:2017 has been approved by CEN as EN ISO 11609:2017 without any modification.
INTERNATIONAL ISO
STANDARD 11609
Third edition
2017-06
Dentistry — Dentifrices —
Requirements, test methods and
marking
Médecine bucco-dentaire — Dentifrices — Exigences, méthodes
d’essai et marquage
Reference number
ISO 11609:2017(E)
©
ISO 2017
ISO 11609:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 11609:2017(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 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 . 3
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
ISO 11609:2017(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the 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: w w w . i s o .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 © ISO 2017 – All rights reserved

ISO 11609:2017(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
[3]
oral conditions can be found through the US Food and Drug Administration , the American Dental
[4] [16]
Association and the Commission Work Project (8-95) of the FDI World Dental Federation .
INTERNATIONAL STANDARD ISO 11609:2017(E)
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
[1] [2]
hazards are not included in this document. These are covered in ISO 7405 and ISO 10993-1 .
2 Normative references
The fol
...