prEN ISO 11609
(Main)Dentistry - Dentifrices - Requirements, test methods and marking (ISO/DIS 11609:2024)
Dentistry - Dentifrices - Requirements, test methods and marking (ISO/DIS 11609:2024)
ISO 11609:2017 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.
ISO 11609:2017 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 not included in this document. These are covered in ISO 7405[1] and ISO 10993‑1[2].
Zahnheilkunde - Zahnreinigungsmittel - Anforderungen, Prüfverfahren und Kennzeichnung (ISO/DIS 11609:2024)
Médecine bucco-dentaire - Dentifrices - Exigences, méthodes d’essai et marquage (ISO/DIS 11609:2024)
ISO 11609:2017 spécifie des exigences relatives aux propriétés physiques et chimiques des dentifrices et donne des lignes directrices concernant les méthodes d'essai appropriées. Elle spécifie également des exigences relatives au marquage, à l'étiquetage et à l'emballage des dentifrices.
ISO 11609:2017 s'applique aux dentifrices, y compris les pâtes dentifrices, destinés à être utilisés quotidiennement par les consommateurs avec une brosse à dents, dans le but de favoriser l'hygiène buccale.
ISO 11609:2017 ne spécifie pas d'exigences qualitatives ou quantitatives spécifiques pour une absence de risques biologiques et toxicologiques. Celles-ci sont traitées dans l'ISO 7405[1] et l'ISO 10993‑1[2].
Zobozdravstvo - Zobne paste - Zahteve, preskusne metode in označevanje (ISO/DIS 11609:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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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)
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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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
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RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11609:2024(en)
ii
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
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
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
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 -48
...
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