DIN EN ISO 28888-2014 Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues (ISO 28888 2013) German version EN ISO 28888 2013《牙科学 牙体硬组织上口服灌洗剂腐蚀潜势.pdf

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1、February 2014Translation by DIN-Sprachendienst.English price group 8No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS

2、 71.100.70!%,BU“2093150www.din.deDDIN EN ISO 28888Dentistry Screening method for erosion potential of oral rinses on dental hardtissues (ISO 28888:2013);English version EN ISO 28888:2013,English translation of DIN EN ISO 28888:2014-02Zahnheilkunde Screeningverfahren fr das Erosionspotential von Mund

3、wssern auf Zahnhartgewebe(ISO 28888:2013);Englische Fassung EN ISO 28888:2013,Englische bersetzung von DIN EN ISO 28888:2014-02Mdecine bucco-dentaire Mthode de criblage de lrosion potentielle des tissus durs dentaires due aux rinagesoraux (ISO 28888:2013);Version anglaise EN ISO 28888:2013,Traductio

4、n anglaise de DIN EN ISO 28888:2014-02www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 12 pages02.14 DIN EN ISO 28888:2014-02 2 A comma is used as the decimal marker. National foreword This document (EN ISO 28888:2013) has been prepared

5、by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Working Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-19 AA Mundpfleg

6、eprodukte. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 11609 DIN EN ISO 11609 ISO 16408 DIN EN ISO 16408 ISO 28399 DIN EN ISO 28399 National Annex NA (informative) Bibliography DIN EN I

7、SO 1942, Dentistry Vocabulary DIN EN ISO 11609, Dentistry Dentifrices Requirements, test methods and marking DIN EN ISO 16408, Dentistry Oral hygiene products Oral rinses DIN EN ISO 28399, Dentistry Products for external tooth bleaching DIN ISO 3696, Water for analytical laboratory use Specification

8、 and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 28888 October 2013 ICS 97.170 English Version Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues (ISO 28888:2013) Mdecine bucco-dentaire - Mthode de criblage de lrosion potentielle des ti

9、ssus durs dentaires due aux rinages oraux (ISO 28888:2013) Zahnheilkunde - Screeningverfahren fr das Erosionspotential von Mundwssern auf Zahnhartgewebe (ISO 28888:2013) This European Standard was approved by CEN on 31 August 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regula

10、tions 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-CENELEC Management Centre or to any CEN member

11、. 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-CENELEC Management Centre has the same status as the official versions. CEN

12、 members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, P

13、ortugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in an

14、y form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 28888:2013: EContents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms and definitions 5 4 Test method 5 4.1 General 5 4.2 Maximum decrease in pH 5 4.3 Reagents . 6 4.4 Apparatus 6 4.

15、5 Sampling . 7 4.6 Test method 7 5 Test report . 8 Bibliography 10 2DIN EN ISO 28888:2014-02EN ISO 28888:2013 (E) This document (EN ISO 28888:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which

16、 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 April 2014, and conflicting national standards shall be withdrawn at the latest by April 2014. Attention is drawn to the possibilit

17、y 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. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bou

18、nd to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portuga

19、l, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 28888:2013 has been approved by CEN as EN ISO 28888:2013 without any modification. Foreword3DIN EN ISO 28888:2014-02EN ISO 28888:2013 (E)IntroductionThis International Standa

20、rd describes a screening method for assessing the erosion potential of dental hard tissues associated with the use of oral rinses.The primary aim of this International Standard is to provide methodology for screening oral rinses for the potential for tooth erosion.Oral rinses should not cause advers

21、e reactions to the oral soft and hard tissues when used in accordance with the manufacturers recommendation for frequency and duration of use.The range of known side effects and biological hazards is wide and complex. The tissue interaction with a constituent material alone cannot be considered in i

22、solation from the overall device design. Thus, in designing an oral rinse, the choice of the best material with respect to its tissue interaction might result in a less functional product, tissue interaction being only one of a number of characteristics to be considered in making that choice. Where

23、a material is intended to interact with tissue in order to perform its function, the biological response to this interaction can be evaluated.4DIN EN ISO 28888:2014-02EN ISO 28888:2013 (E) 1 ScopeThis International Standard specifies a screening method for the erosion potential of non-fluoridated or

24、al rinses on dental hard tissues.The results of the screening method are intended for use in enamel and/or dentine erosion models.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated refer

25、ences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 78-2, Chemistry Layouts for standards Part 2: Methods of chemical analysisISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use Sp

26、ecification and test methods3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 78-2, ISO 1942 and the following apply.3.1dental erosionprogressive loss of calcified dental hard tissue by chemical processes that do not involve bacterial actionSOURCE: ISO

27、1942:2009, 2.2924 Test method4.1 GeneralThe risk of enamel and dentine erosion due to oral rinses shall be assessed.This method is intended to provide initial screening of potential for erosion for all non-fluoridated oral rinses.In case a product fails the screening test, test methods that are more

28、 complex and close to clinical conditions shall be applied.4.2 Maximum decrease in pHThe maximum allowable decrease in pH of this test method shall be 1,0.Should a decrease of the pH greater than 1,0 be determined, then the oral rinse fails this screening test. In this case, test methods that are mo

29、re complex and close to clinical conditions shall be performed in order to establish the erosive capacity of the oral rinse as specified in ISO 16408.5DIN EN ISO 28888:2014-02EN ISO 28888:2013 (E)4.3 Reagents4.3.1 Calcium chloride dihydrate (CaCl22H2O), reagent grade.4.3.2 Citric acid (C6H8O7), reag

30、ent grade.4.3.3 Potassium hydroxide (KOH), reagent grade.4.3.4 Hydrochloric acid (HCl), reagent grade.4.3.5 Sodium azide (NaN3), reagent grade.4.3.6 Trisodium citrate dihydrate (C6H5Na3O72H2O), reagent grade.4.3.7 Potassium dihydrogen phosphate (KH2PO4), reagent grade.4.3.8 Distilled water (H2O), co

31、mplying with grade 2 of ISO 3696.4.3.9 Reference citrate buffer solutions.Prepare three reference citrate buffer solutions according to 4.6.2. Solution 1: 1,0 % citric acid at pH 3,60 at 25 C; Solution 2: 0,25 % citric acid at pH 3,68 at 25 C; Solution 3: 0,07 % citric acid at pH 3,77 at 25 C.4.4 Ap

32、paratus4.4.1 One 50 ml vessel, composed of (borosilicate) glass.4.4.2 Analytical balance, with an accuracy of 0,1 mg or better.4.4.3 Magnetic stirring apparatus, with PTFE-coated magnetic stirring bar.4.4.4 Volumetric flask, 1 l.4.4.5 Beaker, 100 ml, made of borosilicate glass, clean.4.4.6 Pipette,

33、capable of measuring 1 ml to 0,01 ml.4.4.7 Thermometer, with an accuracy of 0,1 C or better.4.4.8 pH meter (pH electrode), with a sensitivity of 0,05 pH units, calibrated.EXAMPLE 1 Example for calibration: use pH 2,0, 4,0, and 6,0 standards or pH 1,68, 4,01 and 6,86 at 25 C. Use pH standard solution

34、s prepared in accordance with appropriate ISO Guides. Check for a linear response with a slope of at least 58 mV per pH unit.NOTE Ready-to-use pH standards can be used.6DIN EN ISO 28888:2014-02EN ISO 28888:2013 (E) 4.5 SamplingUse two representative samples from each of three batches of the oral rin

35、se (total: six samples).4.6 Test method4.6.1 Preparation of screening solutions4.6.1.1 Preparation of stock solutionsPrepare the following two stock solutions. Stock solution A: 1 mol/l CaCl2: 147,01 g CaCl22H2O in 1 l distilled H2O add 0,02 g NaN3. Stock solution B: 1 mol/l KH2PO4: 136,09 g KH2PO4i

36、n 1 l distilled H2O add 0,02 g NaN3.NOTE The NaN3is added as a preservative to prevent microbial contamination while in storage. Should growth be observed, it is intended that new stock solutions be prepared.4.6.1.2 Preparation of diluted screening solutionPrepare diluted screening solution (calcium

37、 phosphate) as follows.To 500 ml distilled water (4.3.8) in a 1 l volumetric flask, add 1,266 ml 1 mol/l CaCl2(Stock A) and 0,760 ml 1 mol/l KH2PO4(Stock B).Adjust to pH = (5,05 0,05) with HCl.NOTE 1 KOH can be required to raise the pH; typically, HCl is need to lower the pH to the appropriate value

38、.Dilute to 1 l with distilled water (4.3.8).NOTE 2 This solution is prepared fresh daily from the stock calcium phosphate solutions.4.6.2 Preparation of reference buffer citrate solutionsPrepare the reference buffer solutions as described in Table 1 in clean 100 ml glass beakers or other suitable co

39、ntainer.Weigh powdered anhydrous citric acid and trisodium citrate dihydrate on separate weighing dishes; combine crystals in a 100 ml volumetric flask and add distilled water (4.3.8) until the meniscus nears the graduation line.Determine the pH of these solutions using a suitably calibrated pH elec

40、trode and meter, while agitating using a magnetic stirrer.If the pH is more than 0,05 units away from the expected pH, adjust this pH accordingly with 0,1 mol/l potassium hydroxide solution or 0,1 mol/l hydrochloric acid to the expected value.Add distilled water (4.3.8) to make up to the final volum

41、e of 100 ml.7DIN EN ISO 28888:2014-02EN ISO 28888:2013 (E)Table 1 Preparation of reference buffer citrate solutionsSolutionnumberCitric acidmass fraction,%Trisodium citrate dihy-drate(C6H5Na3O72H2O)massCitric acid(C6H8O7)massExpectedpH1 1,00 0,451 g 0,705 g 3,602 0,25 0,114 g 0,178 g 3,683 0,07 0,03

42、1 g 0,048 g 3,774.6.3 Screening procedure4.6.3.1 Test procedurePerform the test at an ambient temperature of between 18 C and 27 C.Measure 25 ml of diluted screening solution (calcium phosphate solution) into the 50 ml reaction vessel. Record the temperature of the solution. Stir at a moderately fas

43、t rate (if controllable, set above 100 r/min) and hold this rate constant throughout the experiment. Place a calibrated pH electrode in the solution and monitor the pH until a constant pH is determined.4.6.3.2 EvaluationAdd 250 l (0,25 ml) of the test material (i.e. reference buffer or oral rinse pr

44、oduct) into the stirring solution.4.6.3.3 Test durationThe reaction will be terminated after recording steady pH.4.6.3.4 Test replicationRepeat test four times with each test sample.4.6.3.5 Data recording and treatmentFor each test, record pH of test material (buffer or oral rinse), starting pH of c

45、alcium phosphate test solution, pH of test solution after addition of test material, and pH change (starting pH minus final pH).Report raw data for each test material.4.6.3.6 EvaluationCalculate the mean pH change out of the four repetitions for each of the six samples and standard deviations of pH

46、change for the test materials. If the mean pH reduction for each of the six samples is equal to or less than 1,0, the oral rinse passes the test. If one sample does not meet the requirement, the rinse shall be tested for erosion by other appropriate methods as specified in ISO 16408.5 Test reportA t

47、est report shall be prepared on the test procedure. The test report shall contain the following information:a) complete identification of the tested oral rinse, including name of the product, manufacturer, lot number, type of administration (e.g. can, paste, syringe);b) storage conditions of the ora

48、l rinse;8DIN EN ISO 28888:2014-02EN ISO 28888:2013 (E) c) number of samples tested;d) indication of pass or fail;e) deviations from the test as described in this International Standard, if appropriate;f) reference to this International Standard, i.e. ISO 28888;g) date of test;h) date and signature o

49、f the person carrying out the test.9DIN EN ISO 28888:2014-02EN ISO 28888:2013 (E)Bibliography1 Foundation ADAPfaffenbarger Research Center, ISO collaborative protocol Evaluation of Simplified Methods to Estimate Relative Erosion Potential of Oral Rinses, Carey and Schmuck, August 20092 Imfeld T. Definition, classification and links. Eur. J. Oral Sci. 1996, 104 pp. 1511553 Pickles M.J. The Teeth and Their Environment. Monogr or