DIN EN ISO 17304-2014 Dentistry - Polymerization shrinkage Method for determination of polymerization shrinkage of polymer-based restorative materials (ISO 17304 2013) German versi.pdf

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1、March 2014Translation by DIN-Sprachendienst.English price group 10No 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 1

2、1.060.10!%,Y“2099154www.din.deDDIN EN ISO 17304Dentistry Polymerization shrinkage: Method for determination of polymerizationshrinkage of polymer-based restorative materials (ISO 17304:2013);English version EN ISO 17304:2013,English translation of DIN EN ISO 17304:2014-03Zahnheilkunde Polymerisation

3、sschrumpfung: Verfahren zur Bestimmung derPolymerisationsschrumpfung von polymerbasierenden Restaurationsmaterialien(ISO 17304:2013);Englische Fassung EN ISO 17304:2013,Englische bersetzung von DIN EN ISO 17304:2014-03Mdecine bucco-dentaire Rtraction la polymrisation: Mthode de dtermination de la rt

4、raction lapolymrisation des matriaux de restauration base de polymres (ISO 17304:2013);Version anglaise EN ISO 17304: 2013,Traduction anglaise de DIN EN ISO 17304:2014-03SupersedesDIN 13907:2007-01www.beuth.deIn case of doubt, the German-language original shall be considered authoritative.Document c

5、omprises 18 pages02.14 DIN EN ISO 17304:2014-03 2 A comma is used as the decimal marker. National foreword This document (EN ISO 17304:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” (Secretariat: SCC, Canada) in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Sec

6、retariat: DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Dental (Dentistry Standards Committee), Working Committee NA 014-00-01 AA Fllungswerkstoffe. The DIN Standards corresponding to the International Standards referred to in this document are as fol

7、lows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 4049 DIN EN ISO 4049 ISO 10650-1 DIN EN ISO 10650-1 ISO 10650-2 DIN EN ISO 10650-2 Amendments This standard differs from DIN 13907:2007-01 as follows: a) the scope has been extended to include flowable self-curing composites; b) the principle

8、of the test method has been given in more detail. Previous editions DIN 13907: 2007-01 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN EN ISO 4049, Dentistry Polymer-based restorative materials DIN EN ISO 10650-1, Dentistry Powered polymerization activators Par

9、t 1: Quartz tungsten halogen lamps DIN EN ISO 10650-2, Dentistry Powered polymerization activators Part 2: Light-emitting diode (LED) lamps DIN ISO 3696, Water for analytical laboratory use Specification and test methods EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM December 2013 ICS 11.060.10 E

10、nglish Version Dentistry - Polymerization shrinkage: Method for determination of polymerization 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

11、base de polymres (ISO 17304:2013) Zahnheilkunde - Polymerisationsschrumpfung: Verfahren zur Bestimmung der Polymerisationsschrumpfung von polymerbasierend en Restaurationsmateriali en(ISO 17304:2013)This European Standard was approved by CEN on 2 November 2013. CEN members are bound to comply with t

12、he 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 CEN-CENELEC Manageme

13、nt 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 has the same status

14、 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, Luxembourg, Malta,

15、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 Brussels 2013 CEN Al

16、l rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 17304:2013 EEN ISO173042DIN EN ISO 17304:2014-03EN ISO 17304:2013 (E) Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms and definitions 5 4 Test

17、method 5 4.1 Principle 5 4.2 General 6 4.3 Materials and reagents 7 4.4 Apparatus 8 4.5 Buoyancy medium . 8 4.6 Preparatory treatment of the test material. 9 4.7 Determination of polymerization shrinkage 10 4.8 Test report . 16 Foreword This document (EN ISO 17304:2013) has been prepared by Technica

18、l 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 June 201

19、4, and conflicting national standards shall be withdrawn at the latest by June 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. A

20、ccording 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, Germ

21、any, 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 17304:2013 has been approved by CEN as EN ISO 17304:2

22、013 without any modification. 3DIN EN ISO 17304:2014-03 EN ISO 17304:2013 (E) IntroductionThis International Standard specifies a test method for the determination of the polymerization shrinkage of external energy-activated polymer-based restorative materials of Class 2, Group 1 (see ISO 4049) and

23、similar core materials.Many test methods have been used over many years to determine this property but no International Standard test has so far been 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

24、developed and verified by a comprehensive interlaboratory test programme comparing it with other methods.4DIN EN ISO 17304:2014-03EN ISO 17304:2013 (E) 1 ScopeThis International Standard specifies a test method for the measurement of the polymerization shrinkage of external energy-activated polymer-

25、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 indispensab

26、le 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, liquid py

27、knometer 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 the p

28、urposes 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 having lo

29、w 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 meth

30、od 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 to its

31、 measurement are also specified to ensure the maximum achievable polymerization in the test 5DIN EN ISO 17304:2014-03 EN ISO 17304:2013 (E) conditions so that the most complete possible shrinkage of the materials will be achieved. This way, differences in the rate of polymerization will, to a large

32、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 unpolymerized specimens under yellow light.NOTE 1 Yellow light may be cre

33、ated 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 polymerized specimens shall be less than 1,0 C.NOTE 2 Measurements

34、 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 polymerized specimens on the same day.1) Details of suitable products

35、 are available from the secretariat of ISO/TC 106. 6DIN EN ISO 17304:2014-03EN ISO 17304:2013 (E) Key1 position 1: for the specimen in air (dry)2 position 2: for the specimen in the buoyancy mediumFigure 1 Example of a density determination apparatus4.3 Materials and reagents4.3.1 General reagent wa

36、ter, 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 151213.7DIN EN ISO 17304:2014-03 EN ISO 17304:2013 (E) 4.3.3 Test material External-energy activated polymer-bas

37、ed 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, pan hanger assembly, and thermometer (see Figure 1).NOTE This equipment may be obtained from scale manu

38、facturers 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 exitance of at least 500 mW/cm2in the range of 400 nm to 515 nm determined in accordance with ISO 10650 (all pa

39、rts) 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 capable of being connected to the vacuum pump (4.4.5)4.4.7 Oven, capable of being maintained at (37 2) C

40、.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, e.g. mixing (conditioner) block.4.4.12 Glass dish, for use with flowable materials, fitting to the measur

41、ement 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 lower weighing pan of the density determination apparatus (4.4.2) shall be at least 20 mm to ensure complete

42、 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 immersed.NOTE The density determination apparatus supplied by various manufacturers differ with regard to the h

43、eight 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 of the buoyancy mediumWeigh (5,000 0,001) g of sodium lauryl sulphate (4.3.2), place it into the volumetri

44、c 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 8DIN EN ISO 17304:2014-03EN ISO 17304:2013 (E) a homogeneous solution is achieved, as determined by visual inspection without magnification. Prepare the buoyancy medium at

45、 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 the water bowl of the determination apparatus in accordance with the distance specifications in 4.5.1 and place it in the desic

46、cator (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) mbar is attained, close the desiccator vacuum port. After (20 5) min, carefully ventilate the dessicator.NOTE 2 This pressur

47、e 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 medium for the current measuring temperature from Table 1.NOTE 3 The density of water is applied instead of the precise density of

48、 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 unpolymeri

49、zed pastes, prepare 6 specimens of 1,0 g each.For the testing of polymerized pastes, prepare 12 specimens of 0,5 g each.4.6 Preparatory treatment of the test material4.6.1 GeneralThe dispensing, movement, and storage of the unpolymerized material shall take place under yellow light. See 4.2.The first 3 mm of the expressed material shall not be used.4.6.2 Test material pastes in syringesDeploy test mater