1、Dentistry Dentifrices Requirements, test methods and marking (ISO 11609:2017)BS EN ISO 11609:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National forewordThis British Standard is the UK implementation of EN ISO 11609:2017. It is identical to ISO 11609:2017. I
2、t supersedes BS EN ISO 11609:2010 , which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/106/7, Oral hygiene products.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to i
3、nclude all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 93824 5ICS 11.060.10; 71.100.70; 97.170Compliance with a British Standard cannot confer immunity from leg
4、al obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2017.Amendments/corrigenda issued since publicationDate Text affected BRITISH STANDARDBS EN ISO 11609:2017EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 11609Jun
5、e 2017ICS 97.170 Supersedes EN ISO 11609:2010EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGCEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN Ref. No. EN ISO 11609:2017: EAll rights of exploitation in any form and by any mean
6、s reserved worldwide for CEN national MembersDentistry - Dentifrices - Requirements, test methods and marking (ISO 11609:2017)Mdecine bucco-dentaire - Dentifrices - Exigences, mthodes dessai et marquage (ISO 11609:2017)Zahnheilkunde - Zahnreinigungsmittel - Anforderungen, Prfverfahren und Kennzeichn
7、ung (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 bib
8、liographical 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 respon
9、sibility 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 Repub
10、lic 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.English VersionEN ISO 11609:2017 (E)European forewordTh
11、is 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
12、 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 responsib
13、le 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,
14、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 Un
15、ited Kingdom.Endorsement noticeThe text of ISO 11609:2017 has been approved by CEN as EN ISO 11609:2017 without any modification.iiBS EN ISO 11609:2017ISO 11609:2017(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements relative to the physical and c
16、hemical properties of dentifrices 24.1 Total fluoride 24.1.1 Total fluoride concentration 24.1.2 Total fluoride in a single-unit container 24.2 Heavy metals . 24.3 pH 24.4 Microbiology . 24.5 Abrasivity . 24.6 Stability 34.7 Readily fermentable carbohydrates 35 Test methods . 35.1 Determination of p
17、H 35.2 Determination of dentine abrasivity 35.3 Determination of enamel abrasivity . 35.4 Determination of stability . 36 Marking and labelling . 37 Packaging . 4Annex A (informative) Abrasivity test procedure American Dental Association (ADA) method 5Annex B (informative) Determination of relative
18、dentifrice abrasivity to enamel and dentine by a surface profile method .12Annex C (informative) A testing of total fluoride in dentifrices 18Bibliography .21 ISO 2017 All rights reserved iiiContents PageBS EN ISO 11609:2017ISO 11609:2017(E)ForewordISO (the International Organization for Standardiza
19、tion) 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
20、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
21、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
22、 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 duri
23、ng 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 volu
24、ntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs 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.Th
25、is 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 reservedBS EN ISO 11609:2017ISO 11609:2017(E)Introducti
26、onDentifrices should not cause any adverse reactions to the oral soft tissues when used in accordance with the manufacturers 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
27、 control of oral conditions can be found through the US Food and Drug Administration3, the American Dental Association4and the Commission Work Project (8-95) of the FDI World Dental Federation16. ISO 2017 All rights reserved vBS EN ISO 11609:2017This page deliberately left blankDentistry Dentifrices
28、 Requirements, test methods and marking (ISO 11609:2017) 1 ScopeThis 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
29、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 not included in this document. These ar
30、e covered in ISO 7405 1and ISO 10993-1 2.2 Normative referencesThe 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 editi
31、on of the referenced document (including any amendments) applies.ISO 1942 , Dentistry VocabularyISO 3696 , Water for analytical laboratory use Specification and test methodsISO 8601 , Data elements and interchange formats Information interchange Representation of dates and timesInternational Nomencl
32、ature of Cosmetic Ingredients (INCI), in International Cosmetic Ingredient Dictionary and Handbook1)3 Terms and definitionsFor 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 a
33、t the following addresses: IEC Electropedia: available at http:/www.electropedia.org/ ISO Online browsing platform: available at http:/www.iso.org/obp 3.1dentifriceany substance or combination of substances specially prepared for the consumers for hygiene of the accessible surfaces of teeth and surr
34、ounding tissues3.2toothpasteany semi-solid dentifrice preparation presented in the form of a paste, cream or gelNote 1 to entry: The products common constituents are abrasives, humectants, binders, surfactants, flavourings, fluorides and other agents for oral health benefits.1) Nomenclature develope
35、d by the Personal Care Products Council (formerly CTFA). Available at: https:/access.personalcarecouncil.org/eweb/DynamicPage.aspx?Site=pcpcWebKey=4513b14e-2f75-4857-85b4-b3697be5d5d9.INTERNATIONAL STANDARD ISO 11609:2017(E) ISO 2017 All rights reserved 1BS EN ISO 11609:2017ISO 11609:2017(E)3.3singl
36、e-unit containercontainer of dentifrice marketed to individual consumers3.4primary containercontainer that is in direct contact with the product4 Requirements relative to the physical and chemical properties of dentifrices4.1 Total fluoride4.1.1 Total fluoride concentrationThe total fluoride concent
37、ration 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 containerThe amount of total fluor
38、ide 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 metalsThe total maximum c
39、oncentration 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 pHWhen tested in accordance with 5.1, the dentifrice shall have a pH below 10,5.4.4 MicrobiologyTesting for microbiological cont
40、amination 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 AbrasivityThe abrasivity of the dentifrice shall not exceed the following limit for dentine: 2,5 times that of the primary reference mate
41、rial, 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.Test in accordance with 5.2 or 5.3 or any other validated metho
42、d of similar sensitivity and accuracy.2 ISO 2017 All rights reservedBS EN ISO 11609:2017ISO 11609:2017(E)4.6 StabilityThe 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 procedure
43、s 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 carbohydratesThe dentifrice shall not contain readily fermentable carbohydrates. Compliance shall be established by the abs
44、ence of such compounds in the complete formula or by performing tests in accordance with commonly used analytical methods.5 Test methods5.1 Determination of pHSuspend one part by mass of the dentifrice into three parts by mass of water for analytical laboratory use complying with ISO 3696 (grade 3).
45、 Determine the pH of the suspension within 10 min, using a pH-meter and electrode assembly.5.2 Determination of dentine abrasivityDetermine the mean relative abrasivity compared to the primary reference sample, or any other reference material calibrated to the primary reference sample for human dent
46、ine, 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, conforming to practices and principles found in References 39 to 44. For other references see, for example, References 23 and 24.5.3 Determination o
47、f enamel abrasivityDetermine 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
48、 sensitivity and accuracy may be used, conforming to practices and principles found in References 39 to 44. For other references see, for example, References 23 and 24.5.4 Determination of stabilityFor the accelerated ageing procedure, the dentifrice shall be stored in its original container at 40 C
49、 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 months25. Following storage, test the product according to this document.6 Marking and labellingWith 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; ISO 2017 All rights reserved 3BS EN
