EN ISO 28888-2013 en Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues《牙科 牙体硬组织上口服灌洗剂腐蚀潜势筛选法》.pdf

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1、BSI Standards PublicationBS EN ISO 28888:2013Dentistry Screening methodfor erosion potential of oralrinses on dental hard tissuesBS EN ISO 28888:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO28888:2013.The UK participation in its preparation was entrus

2、ted to TechnicalCommittee CH/106/7, Oral hygiene products.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The Bri

3、tish Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 73724 4ICS 11.060.01; 97.170Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 3

4、1 October 2013.Amendments issued since publicationDate Text affectedEUROPEAN 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

5、- Mthode de criblage de lrosion potentielle des tissus 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 bo

6、und 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

7、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 responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre

8、 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 Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

9、 Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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

10、Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 28888:2013: EBS EN ISO 28888:2013EN ISO 28888:2013 (E) 3 Foreword This document (EN ISO 28888:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” i

11、n 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 identical text or by endorsement, at the latest by April 2014, and conflicting national standar

12、ds shall be withdrawn at the latest by April 2014. 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. According to the CEN-CENELEC Intern

13、al 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ire

14、land, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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. BS E

15、N ISO 28888:2013ISO 28888:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Test method . 14.1 General . 14.2 Maximum decrease in pH 14.3 Reagents 24.4 Apparatus 24.5 Sampling . 34.6 Test method . 35 Test rep

16、ort . 4Bibliography 6BS EN ISO 28888:2013ISO 28888:2013(E)ForewordISO (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 committee

17、s. 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 Inter

18、national Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to 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 diff

19、erent types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directivesAttention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not

20、be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received. www.iso.org/patentsAny trade name used in this document is information

21、 given for the convenience of users and does not constitute an endorsement.The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care products.iv ISO 2013 All rights reservedBS EN ISO 28888:2013ISO 28888:2013(E)IntroductionThis International Standard describes

22、 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 adverse reactions

23、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 isolation fro

24、m 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 a material i

25、s intended to interact with tissue in order to perform its function, the biological response to this interaction can be evaluated. ISO 2013 All rights reserved vBS EN ISO 28888:2013BS EN ISO 28888:2013Dentistry Screening method for erosion potential of oral rinses on dental hard tissues1 ScopeThis I

26、nternational Standard specifies a screening method for the erosion potential of non-fluoridated oral 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

27、normatively referenced in this document and are indispensable for its application. For dated references, 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

28、of chemical analysisISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use Specification 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 c

29、alcified dental hard tissue by chemical processes that do not involve bacterial actionSOURCE: ISO 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

30、non-fluoridated oral rinses.In case a product fails the screening test, test methods that are more 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

31、 determined, then the oral rinse fails this screening test. In this case, test methods that are more 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.INTERNATIONAL STANDARD ISO 28888:2013(E) ISO 2013 Al

32、l rights reserved 1BS EN ISO 28888:2013ISO 28888:2013(E)4.3 Reagents4.3.1 Calcium chloride dihydrate (CaCl22H2O), reagent grade.4.3.2 Citric acid (C6H8O7), reagent grade.4.3.3 Potassium hydroxide (KOH), reagent grade.4.3.4 Hydrochloric acid (HCl), reagent grade.4.3.5 Sodium azide (NaN3), reagent gra

33、de.4.3.6 Trisodium citrate dihydrate (C6H5Na3O72H2O), reagent grade.4.3.7 Potassium dihydrogen phosphate (KH2PO4), reagent grade.4.3.8 Distilled water (H2O), complying with grade 2 of ISO 3696.4.3.9 Reference citrate buffer solutions.Prepare three reference citrate buffer solutions according to 4.6.

34、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 Apparatus4.4.1 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 Magneti

35、c 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, 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 sensitivit

36、y 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 solutions 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-u

37、se pH standards can be used.2 ISO 2013 All rights reservedBS EN ISO 28888:2013ISO 28888:2013(E)4.5 SamplingUse two representative samples from each of three batches of the oral rinse (total: six samples).4.6 Test method4.6.1 Preparation of screening solutions4.6.1.1 Preparation of stock solutionsPre

38、pare 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 KH2PO4in 1 l distilled H2O add 0,02 g NaN3.NOTE The NaN3is added as a preservative to prevent microbial contamination while in

39、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 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)

40、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.Dilute to 1 l with distilled water (4.3.8).NOTE 2 This solution is prepared fresh daily from the stock calcium phosphat

41、e 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 container.Weigh powdered anhydrous citric acid and trisodium citrate dihydrate on separate weighing dishes; combine crysta

42、ls 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 electrode and meter, while agitating using a magnetic stirrer.If the pH is more than 0,05 units away from the expected pH, a

43、djust 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 volume of 100 ml. ISO 2013 All rights reserved 3BS EN ISO 28888:2013ISO 28888:2013(E)Table 1 Preparation of reference buffer

44、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 0,031 g 0,048 g 3,774.6.3 Screening procedure4.6.3.1 Test procedurePerform the test at an ambient temp

45、erature 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 fast rate (if controllable, set above 100 r/min) and hold this rate constant throughout the experimen

46、t. 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 product) into the stirring solution.4.6.3.3 Test durationThe reaction will be terminated after recor

47、ding 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 calcium phosphate test solution, pH of test solution after addition of test material, and pH change

48、 (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 change for the test materials. If the mean pH reduction for each of the six samples is equal to or

49、 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 test 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 oral rinse;4 ISO 2013