EN ISO 11609-2010 en Dentistry - Dentifrices - Requirements test methods and marking《牙科学 洁齿剂 要求 试验方法和标志》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11609:2010Dentistry Dentifrices Requirements, test methodsand marking (ISO 11609:2010)BS EN ISO 11609:2010 BRITISH STANDARDNational forewordThis British Standard is the

2、 UK implementation of EN ISO11609:2010. It supersedes BS EN ISO 11609:1998 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/7, Oral hygiene products.A list of organizations represented on this committee can beobtained on request to its secretary.T

3、his publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2010ISBN 978 0 580 59583 7ICS 11.060.10; 71.100.70; 97.170Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard

4、 was published under the authority of theStandards Policy and Strategy Committee on 30 September 2010.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11609 September 2010 ICS 97.170 Supersedes EN ISO 11609:1998English Version Dentistry -

5、Dentifrices - Requirements, test methods and marking (ISO 11609:2010) Mdecine bucco-dentaire - Dentifrices - Exigences, mthodes dessai et marquage (ISO 11609:2010) Zahnheilkunde - Zahnputzmittel - Anforderungen, Prfverfahren und Kennzeichnung (ISO 11609:2010) This European Standard was approved by C

6、EN 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 standard

7、s 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 t

8、he 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, Ma

9、lta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exp

10、loitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11609:2010: EBS EN ISO 11609:2010EN ISO 11609:2010 (E) 3 Foreword The text of ISO 11609:2010 has been prepared by Technical Committee ISO/TC 106 “Dentistry“ of the International Organization for Stand

11、ardization (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

12、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

13、 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, Finlan

14、d, 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 IS

15、O 11609:2010 without any modification. BS EN ISO 11609:2010ISO 11609:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative references1 3 Terms and definitions .1 4 Requirements relative to the physical and chemical properties of dentifices2 4.1 Total f

16、luoride2 4.1.1 Total fluoride concentration.2 4.1.2 Total fluoride in a single-unit container2 4.2 Heavy metals2 4.3 pH2 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

17、5.3 Determination of enamel abrasivity.3 5.4 Determination of stability .3 6 Marking and labelling4 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

18、 a surface profile method12 Annex C (informative) Testing of total fluoride in dentifrices 16 Bibliography19 BS EN ISO 11609:2010ISO 11609:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (

19、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, go

20、vernmental 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/IE

21、C 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 memb

22、er 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, Subcom

23、mittee 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. BS EN ISO 11609:2010ISO 11609:2010(E) ISO 2010 All rights reserved vIntroduction Dentifrices should not cause any adverse reactions to the or

24、al 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 control of oral conditions can be found through the US Food

25、and Drug Administration3, the American Dental Association4and the Commission Work Project (8-95) of the FDI World Dental Federation16. BS EN ISO 11609:2010BS EN ISO 11609:2010INTERNATIONAL STANDARD ISO 11609:2010(E) ISO 2010 All rights reserved 1Dentistry Dentifrices Requirements, test methods and m

26、arking 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

27、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 included in this International Standard. These are covere

28、d in ISO 74051and ISO 10993-12. 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) app

29、lies. 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 Cosm

30、etic Ingredient Dictionary and Handbook1)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

31、of teeth and surrounding tissues 3.2 toothpaste any semi-solid dentifrice preparation presented in the form of a paste, cream or gel NOTE The products common constituents are abrasives, humectants, binders, surfactants, flavourings, fluorides and other agents for oral health benefits. 1) Nomenclatur

32、e developed by the Personal Care Products Council (Formerly CTFA). Available at: http:/www.ctfa.org/council-bookstore. BS EN ISO 11609:2010ISO 11609:2010(E) 2 ISO 2010 All rights reserved3.3 single-unit container container of dentifrice marketed to individual consumers 3.4 primary container containe

33、r that is in contact with the product 4 Requirements relative to the physical and chemical properties of dentifices 4.1 Total fluoride 4.1.1 Total fluoride concentration The total fluoride concentration shall not exceed a mass fraction of 0,15 % when tested in accordance with one of the procedures g

34、iven 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 container The amount of total fluoride in a single-unit container shall not exceed 300 mg. This requirement does not apply to containers

35、 of dentifrice to be dispensed under supervised conditions in community-based caries prevention programmes such as school tooth brushing programmes. 4.2 Heavy metals The total maximum concentration shall not exceed 20 mg/kg. Test in accordance with References 13, 14 or 15, or another validated metho

36、d of similar sensitivity and accuracy. 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 according to References 17 to 22 and 31 to 38 or any other validated method of equivalent sensi

37、tivity, accuracy and specificity. 4.5 Abrasivity The abrasivity of the dentifrice shall not exceed the following limits for dentine: 2,5 times that of the primary reference material, if using the procedure specified in Annex A; or 2 times that of the primary reference material, if using the procedur

38、es specified in Annex B. BS EN ISO 11609:2010ISO 11609:2010(E) ISO 2010 All rights reserved 3The abrasivity of the dentifrice shall not exceed the following limits for enamel: 4 times that of the primary reference material, if using the procedure specified in Annex A; or 4 times that of the primary

39、reference material, if using the procedures specified in Annex B. Test in accordance with 5.2 or 5.3 or any other validated method of similar sensitivity and accuracy. 4.6 Stability The dentifrice shall show no deterioration that may affect compliance with this International Standard after being sub

40、jected 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. Com

41、pliance 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 laborat

42、ory use complying 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

43、 the primary reference sample for human dentine, 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; see for example References 23 and 24. 5.3 Determination of enamel abrasivity Determine the mean relativ

44、e 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 sensitivity and accuracy may be used; see f

45、or example References 23 and 24. 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 three months or at such conditions of time and temperature as will simulate storage at room tem

46、perature for 30 months25. Following storage, test the product according to this International Standard. BS EN ISO 11609:2010ISO 11609:2010(E) 4 ISO 2010 All rights reserved6 Marking and labelling With the exception of small single units (less than 10 ml), all primary containers shall be marked with

47、the following information: a) the word “dentifrice” or equivalent (see Clause 3); 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

48、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 according to ISO 8601,

49、if the period of stability (shelf-life) is less than 30 months; i) a safety notice regarding the use, by children below six years of age, of dentifrices containing concentrations of fluoride of 1 000 g/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 compliance with th