BS EN ISO 17304-2013 Dentistry Polymerization shrinkage Method for determination of polymerization shrinkage of polymer-based restorative materials《牙科 聚合收缩 聚合物机恢复性材料的聚合收缩作用测定方法》.pdf

1、BSI Standards PublicationBS EN ISO 17304:2013Dentistry Polymerizationshrinkage: Methodfor determination ofpolymerization shrinkage ofpolymer-based restorativematerialsBS EN ISO 17304:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO17304:2013.The UK parti

2、cipation in its preparation was entrusted to TechnicalCommittee CH/106/1, Dental restorative and orthodontic materials.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 contra

3、ct. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 75560 6ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authori

4、ty of theStandards Policy and Strategy Committee on 31 December 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 17304 December 2013 ICS 11.060.10 English Version Dentistry - Polymerization shrinkage: Method for determination of polym

5、erization shrinkage of polymer-based restorative materials (ISO 17304:2013) Mdecine bucco-dentaire - Rtraction la polymrisation: Mthode de dtermination de la rtraction la polymrisation des matriaux de restauration base de polymres (ISO 17304:2013) Zahnheilkunde - Polymerisationsschrumpfung: Verfahre

6、n zur Bestimmung der Polymerisationsschrumpfung von polymerbasierenden Restaurationsmaterialien (ISO 17304:2013) This European Standard was approved by CEN on 2 November 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Eur

7、opean 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. This European Standard exists in three official versio

8、ns (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 members are the national standards bodies of Austria, B

9、elgium, 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, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Swi

10、tzerland, 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 any form and by any means reserved worldwide for CEN natio

11、nal Members. Ref. No. EN ISO 17304:2013 EBS EN ISO 17304:2013EN ISO 17304:2013 (E) 3 Foreword This document (EN ISO 17304:2013) 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. Thi

12、s 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 June 2014, and conflicting national standards shall be withdrawn at the latest by June 2014. Attention is drawn to the possibility that some of the ele

13、ments 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 bound to implement this E

14、uropean 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, Portugal, Romania, Slovakia,

15、Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 17304:2013 has been approved by CEN as EN ISO 17304:2013 without any modification. BS EN ISO 17304:2013ISO 17304:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Sco

16、pe . 12 Normative references 13 Terms and definitions . 14 Test method . 14.1 Principle 14.2 General . 24.3 Materials and reagents . 34.4 Apparatus 44.5 Buoyancy medium 44.6 Preparatory treatment of the test material 54.7 Determination of polymerization shrinkage . 64.8 Test report 12BS EN ISO 17304

17、:2013ISO 17304:2013(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 committees. Each member body interested in a

18、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 International Electrotechnical Commission

19、 (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 different types of ISO documents should

20、be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2. www.iso.org/directives.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

21、 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/patents.Any trade name used in this document is information given for the convenience of user

22、s and does not constitute an endorsement.The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials.iv ISO 2013 All rights reservedBS EN ISO 17304:2013ISO 17304:2013(E)IntroductionThis International Standard specifies a test method for

23、the determination of the polymerization shrinkage of external energy-activated polymer-based restorative materials of Class 2, Group 1 (see ISO 4049) and similar core materials.Many test methods have been used over many years to determine this property but no International Standard test has so far b

24、een adopted. The method specified herein is a simple method that provides reproducible results that will aid users in the comparison of test data. It was developed and verified by a comprehensive interlaboratory test programme comparing it with other methods. ISO 2013 All rights reserved vBS EN ISO

25、17304:2013BS EN ISO 17304:2013Dentistry Polymerization shrinkage: Method for determination of polymerization shrinkage of polymer-based restorative materials1 ScopeThis International Standard specifies a test method for the measurement of the polymerization shrinkage of external energy-activated pol

26、ymer-based restorative materials such as composites and core materials.The method is not suitable for Class 1 (self-curing, see ISO 4049) polymer-based restorative materials.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indisp

27、ensable 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 1183-1, Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liqu

28、id pyknometer method and titration methodISO 1942, Dentistry VocabularyISO 3696:1987, Water for analytical laboratory use Specification and test methodsISO 4049, Dentistry Polymer-based restorative materialsISO 10650 (all parts), Dentistry Powered polymerization activators3 Terms and definitionsFor

29、the purposes of this document, the terms and definitions in ISO 1183-1, ISO 1942, ISO 4049, and the following apply.3.1high-viscosity materialspolymer-based restorative materials having little flow so that they hold their shape on moulding3.2flowable materialspolymer-based restorative materials havi

30、ng low viscosity so that they do not hold their shape on moulding4 Test method4.1 PrincipleThe polymerization shrinkage of external energy-activated polymer-based restorative materials is determined using density determinations in accordance with the buoyancy method (Archimedes principle). This test

31、 method accords with method A (immersion method), described in general terms in ISO 1183-1.Ensure that test conditions such as temperature, duration of exposure, and distance between light guide and the test specimen are controlled and reproducible. Pre-test storage conditions of the polymer prior t

32、o its measurement are also specified to ensure the maximum achievable polymerization in the test INTERNATIONAL STANDARD ISO 17304:2013(E) ISO 2013 All rights reserved 1BS EN ISO 17304:2013ISO 17304:2013(E)conditions so that the most complete possible shrinkage of the materials will be achieved. This

33、 way, differences in the rate of polymerization will, to a large extent, be balanced out.4.2 GeneralPerform all measurements at a room temperature of (23 2) C.Store all specimens at a temperature of (23 2) C for at least 30 min before the start of measurement.Perform all measurements of the unpolyme

34、rized specimens under yellow light.NOTE 1 Yellow light may be created by filtering ambient lighting with a suitable filter1).When handling test materials, wear appropriate rubber gloves, e.g. latex or nitrile.The temperature fluctuation during the measurement of the unpolymerized specimens and the p

35、olymerized specimens shall be less than 1,0 C.NOTE 2 Measurements can be performed at temperatures between 21 C and 25 C. Temperature variations during measurement below 1,0 C do not significantly influence the results.Perform the corresponding density measurements for the unpolymerized and the poly

36、merized specimens on the same day.1) Details of suitable products are available from the secretariat of ISO/TC 106. 2 ISO 2013 All rights reservedBS EN ISO 17304:2013ISO 17304:2013(E)Key1 position 1: for the specimen in air (dry)2 position 2: for the specimen in the buoyancy mediumFigure 1 Example o

37、f a density determination apparatus4.3 Materials and reagents4.3.1 General reagent water, use water prepared in accordance with ISO 3696 Grade 3.4.3.2 Sodium lauryl sulphate, with at least 99,0 % (mass concentration) purity.NOTE The CAS number of sodium lauryl sulphate is 151213. ISO 2013 All rights

38、 reserved 3BS EN ISO 17304:2013ISO 17304:2013(E)4.3.3 Test material External-energy activated polymer-based restorative material or polymeric core material.4.4 Apparatus4.4.1 Analytical balance, accurate to 0,000 1 g.4.4.2 Density determination apparatus, consisting essentially of a platform, beaker

39、, pan hanger assembly, and thermometer (see Figure 1).NOTE This equipment may be obtained from scale manufacturers as a special accessory (density determination kit).4.4.3 Thermometer, accurate in the range 20 C to 30 C, graduated in steps of 0,1 C.4.4.4 External energy source, with a radiant exitan

40、ce of at least 500 mW/cm2in the range of 400 nm to 515 nm determined in accordance with ISO 10650 (all parts) and recommended by the manufacturer of the test material for use with that material.4.4.5 Vacuum pump, with pressure gauge (manometer), accurate to 10 mbar.4.4.6 Desiccator, with a valve and

41、 capable of being connected to the vacuum pump (4.4.5)4.4.7 Oven, capable of being maintained at (37 2) C.4.4.8 Spatula.4.4.9 Transfer medium, suitable for the unpolymerized paste, e.g. microscope slide.4.4.10 Volumetric flask, of size 500 ml, with stopper.4.4.11 Smooth, non-absorbent, stable base,

42、e.g. mixing (conditioner) block.4.4.12 Glass dish, for use with flowable materials, fitting to the measurement pans of the determination apparatus (4.4.2), e.g. diameter of about 20 mm and a height of about 10 mm.4.5 Buoyancy medium4.5.1 Determination of immersion depthThe immersion depth of the low

43、er weighing pan of the density determination apparatus (4.4.2) shall be at least 20 mm to ensure complete immersion. Immersion depth is measured from the upper edge of the weighing pan to the meniscus of the buoyancy medium.For flowable materials, the specimen and the dish shall be completely immers

44、ed.NOTE The density determination apparatus supplied by various manufacturers differ with regard to the height and diameter of their water bowls. It is necessary to establish a standard immersion depth for the lower weighing pan in the buoyancy medium to ensure complete immersion.4.5.2 Preparation o

45、f the buoyancy mediumWeigh (5,000 0,001) g of sodium lauryl sulphate (4.3.2), place it into the volumetric flask (4.4.10), and then add water (4.3.1) until a final weight of (500 0,001) g is reached. Seal the flask and shake it until 4 ISO 2013 All rights reservedBS EN ISO 17304:2013ISO 17304:2013(E

46、)a homogeneous solution is achieved, as determined by visual inspection without magnification. Prepare the buoyancy medium at least 24 h prior to testing.NOTE 1 This solution can be stored for four weeks at room temperature.On the day of the test, pour the necessary amount of buoyancy medium into th

47、e water bowl of the determination apparatus in accordance with the distance specifications in 4.5.1 and place it in the desiccator (4.4.6).Degas the buoyancy medium by evacuating the desiccator at a temperature of (23 2) C using the vacuum pump (4.4.5). Immediately after a vacuum pressure of (50 10)

48、 mbar is attained, close the desiccator vacuum port. After (20 5) min, carefully ventilate the dessicator.NOTE 2 This pressure was chosen so that the water does not boil.Afterwards, the buoyancy medium shall be kept at a temperature of (23 2) C for at least 2 h.Read the density of the buoyancy mediu

49、m for the current measuring temperature from Table 1.NOTE 3 The density of water is applied instead of the precise density of the buoyancy medium. The dependence on temperature will thereby be taken into account. The accuracy of the measured polymerization shrinkage will thereby not be impaired because the differences in the respective densities balance each other out.4.5.3 Number of specimensFor the testing of unpolymerized pastes, prepare 6 specimens of 1,0 g each.For the testing of pol