1、September 2013 Translation by DIN-Sprachendienst.English price group 11No 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).
2、ICS 11.060.01!%(u$“2058201www.din.deDDIN EN ISO 29022Dentistry Adhesion Notched-edge shear bond strength test (ISO 29022:2013);English version EN ISO 29022:2013,English translation of DIN EN ISO 29022:2013-09Zahnheilkunde Adhsion Prfung der Abscherverbundfestigkeit mit einer ausgesparten Klinge (ISO
3、 29022:2013);Englische Fassung EN ISO 29022:2013,Englische bersetzung von DIN EN ISO 29022:2013-09Mdecine bucco-dentaire Adhrence Essai de rsistance au cisaillement sur chantillons bord entaill (ISO 29022:2013);Version anglaise EN ISO 29022:2013,Traduction anglaise de DIN EN ISO 29022:2013-09www.beu
4、th.deIn case of doubt, the German-language original shall be considered authoritative.Document comprises 18 pages08.13 DIN EN ISO 29022:2013-09 2 A comma is used as the decimal marker. National foreword This document (EN ISO 29022:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry”
5、 in collaboration with Technical Committee CEN/TC 55 “Dentistry” (Secretariat: 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 t
6、o the International Standards referred to in Clause 2 of this standard are as follows: ISO 1942 DIN EN ISO 1942 ISO 3696 DIN ISO 3696 ISO 6344-1 DIN ISO 6344-1 National Annex NA (informative) Bibliography DIN EN ISO 1942, Dentistry Vocabulary DIN ISO 3696, Water for analytical laboratory use Specifi
7、cation and test methods DIN ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 29022June 2013 ICS 11.060.10 English Version Dentistry - Adhesion - Notched-edge shear bond strength test (ISO 29022:2013) Mdecin
8、e bucco-dentaire - Adhrence - Essai de rsistance au cisaillement sur chantillons bord entaill (ISO 29022:2013) This European Standard was approved by CEN on 11 April 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this Europea
9、n 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 versions (
10、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, Belgi
11、um, 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, Switzer
12、land, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG 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 national Members. Ref
13、. No. EN ISO 29022:2013: EZahnheilkunde - Adhsion - Prfung der Abscherverbundfestigkeit mit einer ausgesparten Klinge (ISO 29022:2013) Contents Page Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references. 5 3 Terms and definitions 5 4 Tooth substrate and storage . 5 4.1 General 5 4.2 Time
14、after extraction 6 4.3 Condition of teeth . 6 4.4 Initial preparation and storage of teeth 6 5 Tooth surface preparation . 6 5.1 General 6 5.2 Potting (mounting) of teeth . 6 5.3 Surface preparation . 7 5.4 Storage of prepared specimens . 7 6 Specimen production, handling and storage 7 6.1 General 7
15、 6.2 Preconditioning 7 6.3 Application of adhesive . 7 6.4 Insertion into bonding clamp 8 6.5 Composite placement 8 6.6 Specimen handling and storage . 8 7 Notched-edge shear test . 9 7.1 Apparatus 9 7.2 Shear loading 10 7.3 Test 10 7.4 Recording and treatment of results . 10 7.5 Report 10 Annex A (
16、normative) Detailed drawings of notched-edge shear apparatus 12 DIN EN ISO 29022:2013-09EN ISO 29022:2013 (E) 2Foreword This document (EN ISO 29022:2013) has been prepared by Technical Committee ISO/TC 106 “Dentistry” in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of
17、 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 December 2013, and conflicting national standards shall be withdrawn at the latest by December 2013. Attention is drawn to th
18、e 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 Internal Regulations, the national standards organizations of the following count
19、ries 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, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Pol
20、and, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 29022:2013 has been approved by CEN as EN ISO 29022:2013 without any modification. DIN EN ISO 29022:2013-09EN ISO 29022:2013 (E)3IntroductionThe International Org
21、anization for Standardization (ISO) draws attention to the fact that it is claimed that compliance with this document may involve the use of a patent concerning testing shear bond strength.ISO takes no position concerning the evidence, validity and scope of this patent right.The holder of this paten
22、t right has ensured ISO that he/she is willing to negotiate licenses under reasonable and non-discriminatory terms and conditions with applicants throughout the world. In this respect, the statement of the holder of this patent right is registered with ISO. Information may be obtained from:Neil T. J
23、essop, Ultradent Products, Inc., 505 West 10200 South, South Jordan, Utah 84095-3942, USA.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights other than those identified above. ISO shall not be held responsible for identifying any or a
24、ll such patent rights.The purpose of this International Standard is to establish a simple and easy to use method for documenting a claim that a material adheres to tooth substance. While the method described in this International Standard has been used for comparing dental adhesive materials, users
25、of this International Standard should evaluate usefulness of this method for their particular application(s). There is a variety of other dental adhesion test methods that may also be suitable or preferable, depending on the objective (e.g. academic research).DIN EN ISO 29022:2013-09EN ISO 29022:201
26、3 (E) 41 ScopeThis International Standard specifies a shear test method used to determine the adhesive bond strength between direct dental restorative materials and tooth structure, e.g. dentine or enamel. The method as described is principally intended for dental adhesives. The method includes subs
27、trate selection, storage and handling of tooth structure, as well as the procedure for testing.NOTE 1 Testing adhesion to tooth structure is technique sensitive and experience with the test method is required.NOTE 2 With modification, it may be possible to use this method for adhesive restorative ma
28、terials (e.g. glass-ionomer materials).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 re
29、ferenced document (including any amendments) applies.ISO 1942, Dentistry VocabularyISO 3696, Water for analytical laboratory use Specification and test methodsISO 63441, Coated abrasives Grain size analysis Part 1: Grain size distribution test3 Terms and definitionsFor the purposes of this document,
30、 the terms and definitions given in ISO 1942 and the following apply.3.1bond strengthforce per unit area required to break a bonded assembly with failure occurring in or near the adhesive/adherend interface3.2direct dental restorative materialmaterial used to restore a tooth that is placed in the pl
31、astic or unset state and sets intraorally when used clinically3.3substratematerial upon the surface of which an adhesive is spread for any purpose, such as bonding or coating4 Tooth substrate and storage4.1 GeneralUse bovine incisors or human erupted permanent third molars for the measurement of bon
32、d strength. Record the type of substrate used.DIN EN ISO 29022:2013-09EN ISO 29022:2013 (E)5For bovine teeth, use the labial surface. For human teeth, use the buccal, mesial, distal or lingual surface.NOTE The occlusal surface of human teeth should not be used due to difficulty in finding a suitable
33、 bonding area.Use superficial dentine, i.e. as close to enamel as possible, in order to reduce variations. It is important that the planed dentine surface follow the anatomical plane of the dentine-enamel junction (interface) as closely as possible in order to produce a uniform dentine structure.4.2
34、 Time after extractionUse teeth within 6 months after extraction.NOTE Teeth extracted more than 6 months prior to use may undergo degenerative changes in dentinal proteins.4.3 Condition of teethUse caries-free teeth for bond strength measurement. Do not use human teeth which are restored or are root
35、-filled teeth (endodontically treated).4.4 Initial preparation and storage of teethFor bovine teeth, cut off the roots at the cemento-enamel junction (CEJ) and remove the pulp. For human teeth, wash thoroughly in running water and remove all blood and adherent tissue as soon as possible after extrac
36、tion.Place the teeth in water (ISO 3696, grade 3) at (4 4)C. To minimize deterioration, replace the storage medium at least once every 2 months.Preservatives which do not react with dentine, e.g. 1 % aqueous solution of chloramine-T, may be used. Do not use preservatives which can react with dentine
37、, e.g. aldehydes, or which can inhibit radical polymerization, e.g. phenols. If storage in a preservative has taken place, thoroughly rinse the teeth in running water to remove any preservative solution prior to tooth surface preparation.5 Tooth surface preparation5.1 GeneralA standard, reproducible
38、, flat surface is required. Keep tooth surfaces wet at all times.NOTE Exposure of a tooth surface to the air for several minutes may cause irreversible changes in bonding character. Dentine is especially sensitive to dehydration.5.2 Potting (mounting) of teethPrior to potting the teeth, block the op
39、ening to the pulp chamber with wax or dental cement. Alternatively, use a high viscosity potting medium that does not penetrate the pulp chamber. This can be verified by preparing a set of potted teeth, sectioning them and examining the pulp chambers. Discard the sectioned specimens.Place the tooth
40、bonding side down (labial side down for bovine teeth; buccal, mesial, distal or lingual side down for human teeth) in a cylindrical mould on a level working surface. Plastics or metal rings of approximately 25 mm internal diameter may be used. The height of the mould may vary; 10 mm to 25 mm is sugg
41、ested. If rings are used, a sheet of polyester or similar film may be placed under the rings for easy removal and clean up. Pour a mixed slow-setting viscous self-curing resin or dental die stone into the mould. Remove the potted tooth from the mould as soon as possible after the potting medium has
42、set. Store the potted tooth immediately in water (ISO 3696, grade 3) at (4 4)C.NOTE 1 The heat of polymerization of self-curing resin may adversely affect the tooth. Samples may be cooled in an ice bath during polymerization of the resin.DIN EN ISO 29022:2013-09EN ISO 29022:2013 (E) 6NOTE 2 It is pr
43、eferable to pot teeth soon after cutting off the roots and removing the pulp.NOTE 3 A small flat area which will be parallel to the final bonding surface may be ground in the enamel for easier placement and stabilization of the tooth during the potting process.5.3 Surface preparationFix silicon carb
44、ide abrasive paper, complying with ISO 6344-1, to a hard, flat surface. No more than 4 h before the bonding procedure is planned, prepare a standard surface by a two-step sequential planing process under running water. First use P120 paper until a bonding area sufficient for placing a resin composit
45、e (composite) button with a diameter of 2,38 mm has been exposed, followed by P400 paper until the surface is even and smooth when visually inspected. For dentine, stop the grinding when superficial dentine is exposed. The median grit size for P120 abrasive paper is (125 1) m and for P400 abrasive p
46、aper is (35 1) m. If abrasive papers of grit size P120 or P400 are not available, use abrasive papers with grit size as close as possible to 125 m and 35 m.Grinding may be performed in an automatic grinding machine with rotating abrasive discs and running water. Use a mechanical fixture that orienta
47、tes the abrasive paper perpendicular to the specimen. A suitable machine consists of a grinding mandrel with T-slot grinding plate. Alternatively, place the potted tooth into a fixture in a drill press (tooth orientated downwards), lower and press the rotating tooth against the abrasive paper on a m
48、otorized rotating lapidary wheel under running water.In order to ensure correct alignment in the bonding and test fixtures, ensure that the ground surface is perpendicular to the sides of the potted tooth cylinder and that the top and bottom surfaces of the specimen are parallel. Discard potted grou
49、nd teeth that have perforations into the pulp chamber. Rinse the potted ground teeth well with water after grinding to remove any foreign matter (e.g. residual sandpaper grit).Do not grind too deeply into the dentine or bond strength may be reduced. The amount of area exposed by grinding can be checked by briefly drying the tooth with air for easier visualization of the tooth surface and dentine area.5.4 Storage of prepared specimensAfter grind
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