EN ISO 11609:2010
(Main)Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2010)
Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2010)
ISO 11609:2010 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 11609:2010 applies to dentifrices, including toothpastes, destined to be used by the public on a daily basis with a toothbrush to promote oral hygiene.
Zahnheilkunde - Zahnreinigungsmittel - Anforderungen, Prüfverfahren und Kennzeichnung (ISO 11609:2010)
Diese Internationale Norm legt Anforderungen an die physikalischen und chemischen Eigenschaften von
Zahnreinigungsmitteln fest und beschreibt Anleitungen für geeignete Prüfverfahren. Sie beschreibt auch
Anforderungen an die Kennzeichnung, Etikettierung und Verpackung von Zahnreinigungsmitteln.
Diese Internationale Norm ist anwendbar für Zahnreinigungsmittel, einschließlich Zahnpasten, die jeden Tag
zusammen mit einer Zahnbürste angewendet werden um die Mundhygiene der Allgemeinheit zu verbessern.
In dieser Internationalen Norm werden keine besonderen qualitativen und quantitativen Anforderungen zum
Ausschluss biologischer und toxikologischer Risiken gestellt. Diese Risiken werden in ISO 7405 [1] und
ISO 10993-1 [2] beschrieben.
Médecine bucco-dentaire - Dentifrices - Exigences, méthodes d'essai et marquage (ISO 11609:2010)
L'ISO 11609:2010 spécifie des exigences relatives aux propriétés physiques et chimiques des dentifrices, et donne des recommandations concernant les méthodes d'essai. Elle spécifie également des exigences relatives au marquage, à l'étiquetage et à l'emballage des dentifrices.
L'ISO 11609:2010 est applicable aux dentifrices, y compris les pâtes dentifrices, destinés à être utilisés quotidiennement par le grand public avec une brosse à dents, dans le but de favoriser l'hygiène buccale.
Zobozdravstvo - Zobne paste - Zahteve, preskusne metode in označevanje (ISO 11609:2010)
Ta mednarodni standard določa zahteve za fizične in kemijske lastnosti zobnih past in zagotavlja smernice za ustrezne preskusne metode. Prav tako določa zahteve za označevanje, etiketiranje in pakiranje zobnih past. Ta mednarodni standard velja za zobne paste, vključno z zobnimi pastami, namenjenimi za vsakodnevno javno uporabo z zobno ščetko, za promocijo ustne higiene. Posebne kakovostne in količinske zahteve za odsotnost bioloških in toksikoloških nevarnostmi niso zajete v tem mednarodnem standardu.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2010
1DGRPHãþD
SIST EN ISO 11609:2000
=RER]GUDYVWYR=REQHSDVWH=DKWHYHSUHVNXVQHPHWRGHLQR]QDþHYDQMH ,62
Dentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2010)
Zahnheilkunde - Zahnpasten - Anforderungen, Prüfverfahren und Kennzeichnung (ISO
11609:2010)
Art dentaire - Dentifrices - Exigences, méthodes d'essai et marquage (ISO 11609:2010)
Ta slovenski standard je istoveten z: EN ISO 11609:2010
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11609
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2010
ICS 97.170 Supersedes EN ISO 11609:1998
English Version
Dentistry - Dentifrices - Requirements, test methods and
marking (ISO 11609:2010)
Médecine bucco-dentaire - Dentifrices - Exigences, Zahnheilkunde - Zahnputzmittel - Anforderungen,
méthodes d'essai et marquage (ISO 11609:2010) Prüfverfahren und Kennzeichnung (ISO 11609:2010)
This European Standard was approved by CEN on 31 August 2010.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11609:2010: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
The text of ISO 11609:2010 has been prepared by Technical Committee ISO/TC 106 "Dentistry" of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 11609:2010 by
Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by March 2011, and conflicting national standards shall be withdrawn at
the latest by March 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11609:1998.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11609:2010 has been approved by CEN as a EN ISO 11609:2010 without any modification.
INTERNATIONAL ISO
STANDARD 11609
Second edition
2010-09-01
Dentistry — Dentifrices — Requirements,
test methods and marking
Médecine bucco-dentaire — Dentifrices — Exigences, méthodes
d'essai et marquage
Reference number
ISO 11609:2010(E)
©
ISO 2010
ISO 11609:2010(E)
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ii © ISO 2010 – All rights reserved
ISO 11609:2010(E)
Contents Page
Foreword .iv
Introduction.v
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Requirements relative to the physical and chemical properties of dentifices.2
4.1 Total fluoride.2
4.1.1 Total fluoride concentration.2
4.1.2 Total fluoride in a single-unit container.2
4.2 Heavy metals.2
4.3 pH.2
4.4 Microbiology .2
4.5 Abrasivity .2
4.6 Stability.3
4.7 Readily fermentable carbohydrates .3
5 Test methods .3
5.1 Determination of pH .3
5.2 Determination of dentine abrasivity .3
5.3 Determination of enamel abrasivity.3
5.4 Determination of stability .3
6 Marking and labelling.4
7 Packaging.4
Annex A (informative) Abrasivity test procedure — American Dental Association (ADA) method .5
Annex B (informative) Determination of relative dentifrice abrasivity to enamel and dentine by a
surface profile method.12
Annex C (informative) Testing of total fluoride in dentifrices .16
Bibliography.19
ISO 11609:2010(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11609 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products.
This second edition of ISO 11609 cancels and replaces the first edition (ISO 11609:1995), which has been
technically revised.
iv © ISO 2010 – All rights reserved
ISO 11609:2010(E)
Introduction
Dentifrices should not cause any adverse reactions to the oral soft tissues when used in accordance with the
manufacturer's recommendation for frequency and duration of use, nor cause any known side effects.
Guidelines on assessing the claimed or implied efficacy of dentifrices for the prevention or control of oral
[3] [4]
conditions can be found through the US Food and Drug Administration , the American Dental Association
[16]
and the Commission Work Project (8-95) of the FDI World Dental Federation .
INTERNATIONAL STANDARD ISO 11609:2010(E)
Dentistry — Dentifrices — Requirements, test methods and
marking
1 Scope
This International Standard specifies requirements for the physical and chemical properties of dentifrices and
provides guidelines for suitable test methods. It also specifies requirements for the marking, labelling and
packaging of dentifrices.
This International Standard applies to dentifrices, including toothpastes, destined to be used by the public on a
daily basis with a toothbrush to promote oral hygiene.
Specific qualitative and quantitative requirements for freedom from biological and toxicological hazards are not
[1] [2]
included in this International Standard. These are covered in ISO 7405 and ISO 10993-1 .
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
International Nomenclature of Cosmetic Ingredients (INCI), in International Cosmetic Ingredient Dictionary and
1)
Handbook
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
dentifrice
any substance or combination of substances specially prepared for the public for hygiene of the accessible
surfaces of teeth and surrounding tissues
3.2
toothpaste
any semi-solid dentifrice preparation presented in the form of a p
...
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