DIN EN ISO 17730-2015 Dentistry - Fluoride varnishes (ISO 17730 2014) German version EN ISO 17730 2014《牙科 含氟涂膜 (ISO 17730-2014) 德文版本EN ISO 17730-2014》.pdf

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1、March 2015 Translation 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 7

2、1.100.70!%A*d“2300765www.din.deDDIN EN ISO 17730Dentistry Fluoride varnishes (ISO 17730:2014);English version EN ISO 17730:2014,English translation of DIN EN ISO 17730:2015-03Zahnheilkunde Fluoridlacke (ISO 17730:2014);Englische Fassung EN ISO 17730:2014,Englische bersetzung von DIN EN ISO 17730:201

3、5-03Mdecine bucco-dentaire Vernis fluors (ISO 17730:2014);Version anglaise EN ISO 17730:2014,Traduction anglaise de DIN EN ISO 17730:2015-03www.beuth.deDocument comprises 12 pagesIn case of doubt, the German-language original shall be considered authoritative.02.15 DIN EN ISO 17730:2015-03 2 A comma

4、 is used as the decimal marker. National foreword This document (EN ISO 17730:2014) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was

5、 the DIN-Normenausschuss Dental (DIN Standards Committee Dentistry), Working Committee NA 014-00-19 AA Mundpflegeprodukte. 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 8601 DIN ISO 8601

6、National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN ISO 3696, Water for analytical laboratory use Specification and test methods DIN ISO 8601, Data elements and interchange formats Information interchange Representation of dates and times EUROPEAN STANDARD NORME EU

7、ROPENNE EUROPISCHE NORM EN ISO 17730 November 2014 ICS 97.170 English Version Dentistry Fluoride varnishes (ISO 17730:2014) Mdecine bucco-dentaire Vernis fluors (ISO 17730:2014) Zahnheilkunde Fluoridlacke (ISO 17730:2014) This European Standard was approved by CEN on 23 August 2014. CEN members are

8、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 standards may be obtained on application to th

9、e 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 Cent

10、re 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, Lithuani

11、a, 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-100

12、0 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17730:2014 E Contents PageForeword 3Introduction 41 Scope . 52 Normative references 53 Terms and Definitions 54 Requirements 64.1 Total fluoride content 65 Samplin

13、g 66 Test method . 66.1 Test for total fluoride content 66.2 Test conditions 77 Test report . 88 Instructions for use . 89 Packaging, labelling, and marking . 99.1 Packaging . 99.2 Labelling . 9Bibliography . 10DIN EN ISO 17730:2015-03 EN ISO 17730:2014 (E) 2Foreword This document (EN ISO 17730:2014

14、) 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 identical text or by endorse

15、ment, at the latest by May 2015, and conflicting national standards shall be withdrawn at the latest by May 2015. 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

16、 or all such patent rights. 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, Finland, Former Yugoslav Republ

17、ic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, 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 17730:2014 has been appr

18、oved by CEN as EN ISO 17730:2014 without any modification. DIN EN ISO 17730:2015-03 EN ISO 17730:2014 (E) 3IntroductionFluoride varnishes are used in dentistry primarily for caries prevention and reduction of dentine hypersensitivity. Fluoride varnishes are applied in the oral cavity directly on the

19、 outer surfaces of teeth and fillings, and are intended to remain at least for several hours.Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazard are not included in this International Standard, but it is recommended that, for the assessmen

20、t of possible biological or toxicological hazards, reference should be made to ISO 10993-1 and ISO 7405.DIN EN ISO 17730:2015-03 EN ISO 17730:2014 (E) 41 ScopeThis International Standard specifies requirements and their test methods for total digestible fluoride content in dental varnishes containin

21、g fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies the requirements for their packaging and labelling, including the instructions for use. This International Standard covers fluoride varnishes to be applied by dental health care wo

22、rkers.2 Normative referencesThe following documents, in whole or in part, are 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

23、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 times3 Terms and DefinitionsFor the purposes of this document, the definit

24、ions given in ISO 1942 and the following apply.3.1consumer packagingretail packagingsales packagingpackage, with labelling and contents as a sales unit to the user or consumer at the point of retailNote 1 to entry: A consumer packaging can consist of a secondary packaging wrapping or container cover

25、ing one or more primary packaging elements or, it can consist of a single primary packaging element containing the product.Note 2 to entry: Adapted from ISO 21067:2007, definition 2.2.5.3.2fluoride varnishdental product, in paintable liquid form containing fluoride compound for topical application t

26、o the outer surfaces of teeth and fillings, intended primarily to prevent tooth caries or reduce dentine hypersensitivity3.3total fluoridemass percent of fluoride in the fluoride varnishDIN EN ISO 17730:2015-03 EN ISO 17730:2014 (E) 54 Requirements4.1 Total fluoride contentThe total fluoride content

27、 shall not deviate by more than 20 % from the stated amount on the package when tested in accordance with 6.1 or other validated methods for total fluoride content.5 SamplingUse packages prepared for retail sale from the same batch containing enough material to carry out the specified tests, plus an

28、 allowance for repeat tests, if necessary.6 Test method6.1 Test for total fluoride content6.1.1 Chemicals and solutions6.1.1.1 Total ionic strength adjusting buffer (TISAB) solution, described in ASTM D1179-10:2010 18.1 or alternative.NOTE TISAB II: Sodium chloride 5,8 % (w/v), acetic acid 5,7 % (w/

29、v), CDTA 0,4 % (w/v) adjust to pH 5 to pH 5,5 with sodium hydroxide (5 mol/L). Examples are TISAB II(Orion Research). An acceptable product (TISAB II) is available from Thermo Fisher Scientific, Beverly, MA 01915 USA. This information is given only for the convenience of users of this document and d

30、oes not constitute an endorsement by ISO of this product.6.1.1.2 50 % Diluted TISAB solution, dilute TISAB with deionized water 1:1 by volume.6.1.1.3 Fluoride standard solution, commercially available or prepared with sodium fluoride at 0,10 mol/L.6.1.1.4 Chloroform, reagent grade.6.1.1.5 Deionized

31、water, in accordance with ISO 3696:1987, grade 2.6.1.1.6 Potassium hydroxide at 1 mol/L.6.1.2 Apparatus6.1.2.1 Chloroform resistant vials and caps, 25 mL or more capacity.6.1.2.2 Balance accurate to 0,000 1 g.6.1.2.3 Magnetic stir bar.6.1.2.4 Magnetic stir plate.6.1.2.5 Pipette, capable of measuring

32、 1 mL to 0,01 mL.6.1.2.6 Fluoride ion selective electrode (F-ISE), with reference electrode, or combination F-ISE/reference electrode pair.DIN EN ISO 17730:2015-03 EN ISO 17730:2014 (E) 66.1.2.7 Plastic vial (or beaker or small container), 25 mL or more capacity.6.1.2.8 pH/mV electrometer (pH meter)

33、, with a sensitivity of 0,1 mV.Perform tests on “as received” samples.6.2 Test conditionsPerform tests at room temperature with no more than 2 C variation.6.2.1 Preparation of standard solutionMake successive dilutions of the fluoride standard solution to obtain a set of working standard solutions t

34、hat are 102, 103, 104, 105mol/L NaF.6.2.2 Preparation of calibration curvea) Pipette 5,0 mL of each standard solution into a separate plastic vial (or beaker or small container).b) Add 5,0 mL of TISAB solution, add a magnetic stir bar to each plastic vial. Mix thoroughly.c) Insert the fluoride ion s

35、elective and reference electrodes into the liquid in the plastic vial containing the first standard solution.d) Record the millivolt reading to 0,1 mV at the steady potential difference with the mV electrometer.e) Conduct at least two measurements for millivolt readings until the difference between

36、the two readings is less than 0,2 mV.f) Repeat steps (c) to (e) for each of the other standard solutions.g) Construct a calibration curve of millivolts versus the log of the fluoride ion concentration of the standard.NOTE The slope of the calibration curve should be linear and no less than 55 mV per

37、 decade (-log10F), and the l c coefficient of determination (r2) should be greater than 0,98.6.2.3 Sample preparationa) Place open chloroform resistant vial that can be capped, such as a scintillation vial, on balance and tare to zero.b) Dispense 1 to 3 drops (0,05 g to 0,15 g) of varnish product on

38、to the bottom of the container.c) Determine and record the mass of the amount of varnish Varnishmass added to 0,000 1 g.d) If the varnish sample contains fluorosilane, add 1,0 mL of 1 mol/L KOH to the varnish in the container and mix for 5 min. If the varnish sample does not contain fluorosilane the

39、n skip this step.e) Add (4 0,5) mL of chloroform into the container and stir.f) Add (10,0 0,1) mL of TISAB buffer to the chloroform + sample.g) Cap and vigorously shake the mixture to dissolve the resin into the chloroform and all the fluoride into the TISAB. Be careful to allow the pressure in the

40、vial to escape by loosening the cap briefly and retightening.h) Add magnetic stir bar.i) Stir for at least 1,5 h at room temperature.DIN EN ISO 17730:2015-03 EN ISO 17730:2014 (E) 7NOTE In some cases the TISAB/Chloroform/Varnish mixture does not mix well with magnetic stirring, it may be necessary t

41、o place the sample vial into a rotator or shaker to achieve better mixing.j) Turn off magnetic stir plate for at least 2 h (to allow the chloroform and the TISAB to separate);k) If the top (aqueous) layer is not uniform, gently homogenize (mix) just that layer prior to sampling for further dilution.

42、6.2.4 Sample Analysisa) Pipette 1,0 mL of aqueous (TISAB) layer (prevent to include parts of the lower chloroform layer) into a 25 mL container.b) Pipette 1,0 mL deionized water into the same container.c) Add 18,0 mL 50 % diluted TISAB solution to the container and stir.d) Insert the fluoride ion se

43、lective and reference electrodes into the sample liquid in the vial. Record the millivolt reading to the nearest 0,1 mV at the steady potential difference.e) Use the calibration curve of standard solutions to determine the fluoride ion concentration in the sample solution in mol/L.6.2.5 Calculations

44、a) Determine the apparent concentration Fdil (mol/L) of the diluted sample from the standard curve.b) Multiply the Fdil by 100 and divide by Varnishmass = F mmol/g product.NOTE When calculating the F mol/L of the standard, it is common practice to ignore the volume fraction of 50 % dilution caused b

45、y the addition of TISAB because the standards and samples all receive the same dilution. Should the standard curve be calculated with the actual F mol/L (including the volume fraction of 50 % TISAB dilution) then the dilution factor to be used in the calculations 6.2.5.b) will be 200 in place of 100

46、 when calculating the F mmol/g product.c) Multiply F mmol/g product by 19 000 = mg F/g.d) Multiply F mmol/g product by 41 990 = mg NaF/g.e) Divide mg F/g by 10 000 = mass % F.f) Divide mg NaF/g by 10 000 = mass % NaF.7 Test reportThe test report shall include at least the following information:a) na

47、me and address of the institute responsible for the test report;b) a reference to this International Standard (i.e. ISO 17730);c) the manufacturers tracking code;d) the test methods used and their results;e) any unusual features noted during the tests;f) whether the fluoride varnish passed or failed

48、 the test.8 Instructions for useInstructions shall indicate the method of application of the fluoride varnish to teeth.DIN EN ISO 17730:2015-03 EN ISO 17730:2014 (E) 89 Packaging, labelling, and marking9.1 PackagingThe materials shall be supplied in containers or capsules that afford adequate protection and have no adverse effect on the quality of the contents.9.2 LabellingEach container shall be marked with at least the following information:a) the manufacturers name and addres