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1、BRITISH STANDARD BS EN ISO 11609:1998 Incorporating Amendment No. 1 to BS ISO 11609:1995 (renumbers the BS as BS EN ISO 11609:1998) Dentistry Toothpastes Requirements, test methods and marking The European Standard EN ISO 11609:1998 has the status of a British Standard ICS 11.060.10; 71.100.70 Licen
2、sed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11609:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes in
3、to effect on 15 July 1996 BSI 04-1999 The following BSI references relate to the work on this standard: Committee reference CH/56 Draft for comment 93/508930 DC ISBN 0 580 26129 8 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Com
4、mittee CH/56, Dentifrices, upon which the following bodies were represented: Association of Dental Hospitals of the United Kingdom British Association for the Study of Community Dentistry British Dental Association British Paedodontic Society Cosmetic, Toiletry and Perfumery Association Limited Depa
5、rtment of Health London Dental Study Club Amendments issued since publication Amd. No.DateComments 10061August 1998Indicated by a sideline in the margin Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11609:1998 BSI 04-1999i Conten
6、ts Page Committees responsibleInside front cover National forewordii Foreword2 Forewordii Text of ISO 116091 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11609:1998 ii BSI 04-1999 National foreword This British Standard is the E
7、nglish language version of EN ISO 11609:1998. This British Standard is published under the direction of the Health and Environment Sector Board whose Technical Committee CH/56 has the responsibility to: aid enquirers to understand the text; present to the responsible international committee any enqu
8、iries on interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. NOTEInternational and European Standards, as well as overseas standards, are available from Customer Services, BSI, 389 Chiswick Hi
9、gh Road, London W4 4AL. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages
10、This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 11 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the
11、 amendment table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11609 March 1998 ICS 11.060.10 Descriptors: See ISO document English version Dentistry Tooth
12、pastes Requirements, test methods and marking (ISO 11609:1995) Produits et matriel pour lart dentaire Dentifrice Prescriptions, mthodes dessai et marquage (ISO 11609:1995) Zahnheilkunde Zahnpasten Anforderungen, Prfverfahren und Kennzeichnung (ISO 11609:1995) This European Standard was approved by C
13、EN on 14 February 1998. 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 standa
14、rds may be obtained on application to the Central Secretariat 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
15、he Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United
16、 Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11
17、609:1998 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11609:1998 BSI 04-1999 2 Foreword The text of the International Standard from Technical Committee ISO/TC 106 “Dentistry” of the International Organization for Standardization (I
18、SO) has been taken over as a European Standard 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 September 1998
19、, and conflicting national standards shall be withdrawn at the latest by September 1998. According to CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, F
20、rance, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 11609:1995 has been approved by CEN as a European Standard without any modification. NOTENormat
21、ive references to international publications are listed in Annex ZA (normative). Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN
22、 ISO 11609:1998 ii Contents Page Forewordiii 1Scope1 2Normative references1 3Definitions1 4Requirements1 5Test methods2 6Marking and labelling3 Annex A (normative) Abrasivity test procedure (Hefferren)4 Annex B (informative) Testing of total fluoride in dentifrices8 Annex C (informative) Bibliograph
23、y10 Annex ZA (normative) Normative references to international publications with their relevant European publications11 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11609:1998 BSI 04-1999iii Foreword ISO (the International Organ
24、ization 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 establish
25、ed 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.
26、 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. International Standard ISO 11609 was prepared by Technical Committee ISO
27、/TC 106, Dentistry, in collaboration with the International Dental Federation (FDI). Annex A forms an integral part of this International Standard. Annex B and Annex C are for information only. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI
28、 iv blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11609:1998 BSI 04-19991 1 Scope This International Standard specifies requirements and test methods for physical and chemical properties, and for the marking and/or labellin
29、g of toothpastes for daily use by the public with a toothbrush to promote oral hygiene. NOTE 1It is anticipated that guidelines on claimed or implied efficacy of toothpastes for the prevention or control of oral conditions will be published as an FDI Technical Report. 2 Normative references The foll
30、owing standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are enc
31、ouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 1942:1989, Dental vocabulary. ISO 3696:1987, Water for analytical laboratory use Specification and t
32、est methods. BS 5136:1981, Specification for toothpastes. CTFA, International Cosmetic Ingredients Dictionary1). SHELLIS, R.P. A synthetic saliva for cultural studies of dental plaque. Archives Oral Biol., 23, pp. 485-489, 1978. POPE, D.G. Accelerated stability testing for production of drug product
33、 stability. Drugs and Cosmetics, pp. 54-62, 1980. 3 Definitions For the purposes of this International Standard, the definitions given in ISO 1942 and the following definitions apply. 3.1 dentifrice any substance or combination of substances specially prepared for the public for cleaning the accessi
34、ble surfaces of teeth 3.1 toothpaste any semi-solid dentifrice preparation presented in the form of a paste, cream or gel NOTE 2The products main constituents generally are an abrasive, humectants, a binder, a surfactant and a flavouring. Secondarily, the product may contain agents for oral health m
35、aintenance. 4 Requirements 4.1 Total fluoride The total fluoride concentration shall not exceed the limits set by national laws and regulations and in no case shall the total fluoride concentration exceed 0,15 % (m/m). When using containers, for example dispensing systems of various sorts, the total
36、 fluoride content per single unit shall not exceed 300 mg. Test in accordance with one of the procedures given in Annex B or the EEC method22. Other validated methods of similar sensitivity and accuracy may be used (see references 20 and 21. 4.2 Heavy metals The maximum concentration shall not excee
37、d the limits set by national laws and regulations. In no case shall the total heavy metal concentration in the toothpaste be greater than 20 mg/kg. Test in accordance with reference 10, 11 or 12, or other validated method of similar sensitivity and accuracy. 4.3 Alkalinity When tested in accordance
38、with 5.2.1, the toothpaste shall have a pH below 10,5. 4.4 Demineralization Toothpastes having a pH of less than 5,5 shall be tested for demineralization in accordance with 5.2.2. The enamel lost from teeth exposed to the test shall not exceed that lost from teeth exposed to the control treatment or
39、 shall comply with the requirements of the enamel abrasion test (5.2.2.2). 4.5 Compatibility with oral tissues The toothpaste should not cause irritation or damage to the oral tissue when used as intended by the manufacturer. Test in accordance with 5.2 and 5.3. NOTE 3Specific qualitative and quanti
40、tative requirements for freedom from biological hazards are not included in this International Standard, but it is recommended that reference should be made to ISO/TR 74051 and ISO 10993-12 when assessing possible biological or toxicological hazards. 4.6 Microbiology Testing for microbiological cont
41、amination shall be carried out according to reference 9 or references 3, 4 and 5. 1) See note 4, clause 6. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:01:07 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11609:1998 2 BSI 04-1999 4.7 Abrasivity The abrasivity of the toothpaste sha
42、ll not exceed the following limits for dentin: 2,5 times, if using the procedure specified in Annex A, or 2 times, if using the procedure specified in BS 5136, that of the primary reference material. Test in accordance with 5.3 or any other validated method of similar sensitivity and accuracy. 4.8 S
43、tability The toothpaste shall show no signs of deterioration which may affect compliance with this International Standard after being subjected to the ageing procedure specified in 5.4. 4.9 Readily fermentable carbohydrates The toothpaste shall not contain readily fermentable carbohydrates. Complian
44、ce 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 Visual inspection The toothpaste shall show no signs of deterioration (e.g. separation, discoloration, viscosity/extension d
45、ifficulties) after being stored according to the accelerated ageing procedures specified in 5.4.1. This attests to its compliance with this International Standard. Examine under a bright light with normal visual acuity without magnification. 5.2 Determination of pH and enamel demineralization 5.2.1
46、Determination of pH Suspend one part by mass of the toothpaste into three parts by mass of water for analytical laboratory use complying with ISO 3696 (grade 2). Determine the pH of the suspension within 10 min, using a pH-meter with a glass and calomel electrode assembly. 5.2.2 Determination of ena
47、mel demineralization or abrasion (low pH compositions) The toothpaste shall comply with the requirements of either 5.2.2.1 or 5.2.2.2. 5.2.2.1 Enamel demineralization For toothpaste with a pH below 5,5, use the following procedure. Prepare radioactive human enamel (see Annex A or Annex B) in a manne
48、r that will provide a uniform surface area on all specimens. Perform the irradiation of the specimens in accordance with the procedure for radioactive abrasion tests. Cover the remainder of the enamel with an acid-resistant varnish. Immerse the specimens in artificial saliva for 1 h to promote a sli
49、ght protein film simulating oral conditions. Immerse the specimens individually in 20 ml of 1 : 3 slurries of the test toothpaste in artificial saliva. Stir the slurries constantly and uniformly; maintain continual immersion. Use double-distilled or deionized water (ISO 3696) as a negative control. After immersion for 24 h analyse the slurries for the level of radioactivity (). To pass the test, the enamel lost to the slurries shall not be more than that lost to the water control. 5.2.2.2 Enamel abrasion If the p
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