BS EN ISO 17730-2014 Dentistry Fluoride varnishes《牙科 含氟涂料》.pdf

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1、BSI Standards PublicationBS EN ISO 17730:2014Dentistry Fluoride varnishesBS EN ISO 17730:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO17730:2014.The UK participation in its preparation was entrusted to TechnicalCommittee CH/106/7, Oral hygiene product

2、s.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 British Standards Institution 2014. Published by BSI Standa

3、rdsLimited 2014ISBN 978 0 580 78987 8ICS 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 30 November 2014.Amendments issued since publicationDate Text affect

4、edEUROPEAN STANDARD NORME EUROPENNE 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 o

5、n 23 August 2014. 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 standards ma

6、y be obtained on application to the 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

7、to the CEN-CENELEC 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland

8、, Ireland, Italy, Latvia, Lithuania, 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 Manageme

9、nt Centre: Avenue Marnix 17, B-1000 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 EBS EN ISO 17730:2014EN ISO 17730:2014 (E) 3 Foreword This document (EN ISO 17730:2014) has been prepared by Technical

10、 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 endorsement, at the latest by May 2015,

11、 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 or all such patent rights. Acco

12、rding 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 Republic of Macedonia, France, Germany

13、, 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 approved by CEN as EN ISO 17730:2014

14、 without any modification. BS EN ISO 17730:2014ISO 17730:2014(E)Contents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and Definitions 14 Requirements 24.1 Total fluoride content 25 Sampling 26 Test method . 26.1 Test for total fluoride content 26.2 Test conditions 37 Test

15、report . 48 Instructions for use . 49 Packaging, labelling, and marking . 59.1 Packaging . 59.2 Labelling . 5Bibliography 6 ISO 2014 All rights reserved iiiBS EN ISO 17730:2014ISO 17730:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national stan

16、dards 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 established has the right to be represented on that committee. International org

17、anizations, 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.The procedures used to develop this document and those intended for its

18、 further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/dir

19、ectives).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. Details of any patent rights identified during the development of the document will be in th

20、e Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions relate

21、d to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword Supplementary information .The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC7, Oral care products

22、.iv ISO 2014 All rights reservedBS EN ISO 17730:2014ISO 17730:2014(E)IntroductionFluoride 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 outer surfaces of teeth and fillings,

23、 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 assessment of possible biological or toxicologi

24、cal hazards, reference should be made to ISO 10993-1 and ISO 7405. ISO 2014 All rights reserved vBS EN ISO 17730:2014BS EN ISO 17730:2014Dentistry Fluoride varnishes1 ScopeThis International Standard specifies requirements and their test methods for total digestible fluoride content in dental varnis

25、hes containing 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 h

26、ealth care workers.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 (i

27、ncluding any 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

28、, the definitions 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 co

29、ntainer covering 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

30、application to 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 varnishINTERNATIONAL STANDARD ISO 17730:2014(E) ISO 2014 All rights reserved 1BS EN ISO 17730:2014ISO 17730:

31、2014(E)4 Requirements4.1 Total fluoride contentThe total fluoride content 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 b

32、atch containing enough material to carry out the specified tests, plus an 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 alte

33、rnative.NOTE TISAB II: Sodium chloride 5,8 % (w/v), acetic acid 5,7 % (w/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 info

34、rmation is given only for the convenience of users of this document and does 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 fl

35、uoride at 0,10 mol/L.6.1.1.4 Chloroform, reagent grade.6.1.1.5 Deionized 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 s

36、tir bar.6.1.2.4 Magnetic stir plate.6.1.2.5 Pipette, capable of measuring 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.2 ISO 2014 All rights reservedBS EN ISO 17730:2014ISO 17730:2014(E)6.1.2.7 Plastic vial

37、(or beaker or small container), 25 mL or more capacity.6.1.2.8 pH/mV electrometer (pH meter), 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

38、 dilutions of the fluoride standard solution to obtain a set of working standard solutions that 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 solutio

39、n, add a magnetic stir bar to each plastic vial. Mix thoroughly.c) Insert the fluoride ion selective 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 electromet

40、er.e) Conduct at least two measurements for millivolt readings until the difference between 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

41、standard.NOTE The slope of the calibration curve should be linear and no less than 55 mV per 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, o

42、n balance and tare to zero.b) Dispense 1 to 3 drops (0,05 g to 0,15 g) of varnish product onto 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

43、 in the container and mix for 5 min. If the varnish sample does not contain fluorosilane then 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

44、the chloroform and all the fluoride into the TISAB. Be careful to allow the pressure in the 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. ISO 2014 All rights reserved 3BS EN ISO 17730:2014ISO 17730:2014(E)NOTE In

45、 some cases the TISAB/Chloroform/Varnish mixture does not mix well with magnetic stirring, it may be necessary to 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

46、 (aqueous) layer is not uniform, gently homogenize (mix) just that layer prior to sampling for further dilution.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 s

47、ame container.c) Add 18,0 mL 50 % diluted TISAB solution to the container and stir.d) Insert the fluoride ion selective 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 s

48、tandard solutions to determine the fluoride ion concentration in the sample solution in mol/L.6.2.5 Calculationsa) 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 calcul

49、ating the F mol/L of the standard, it is common practice to ignore the volume fraction of 50 % dilution caused by 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 when calculating the F mmol/g product.c) Multiply F mmol/g product by 19 000 = mg F/g.d) Multiply F