EN ISO 29022-2013 en Dentistry - Adhesion - Notched-edge shear bond strength test《牙科 粘附力 边缘切口的剪切粘结强度试验》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 29022:2013Dentistry Adhesion Notched-edge shear bondstrength test (ISO 29022:2013)BS EN ISO 29022:2013 BRITISH STANDARDNational forewordThis British Standard is the UK

2、implementation of EN ISO29022:2013.The UK participation 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

3、include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 59604 9ICS 11.060.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This B

4、ritish Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2013.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 29022 June 2013 ICS 11.060.10 English Version Dentistry - Adhesion - Notched-e

5、dge shear bond strength test (ISO 29022:2013) Mdecine bucco-dentaire - Adhrence - Essai de rsistance au cisaillement sur chantillons bord entaill (ISO 29022:2013) Zahnheilkunde - Adhsion - Verbundprfung der Abscherfestigkeit mit ausgesparter Klinge (ISO 29022:2013) This European Standard was approve

6、d 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 European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national sta

7、ndards may 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

8、notified 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

9、, Iceland, 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 Management

10、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. No. EN ISO 29022:2013: EBS EN ISO 29022:2013EN ISO 29022:2013 (E) 3 Foreword This document (EN ISO 29022:2013) has been prepared by Technical C

11、ommittee 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 December 20

12、13, and conflicting national standards shall be withdrawn at the latest by December 2013. 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 righ

13、ts. 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 Republic of Macedonia, France,

14、 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 29022:2013 has been approved by CEN as EN ISO 29

15、022:2013 without any modification. BS EN ISO 29022:2013ISO 29022:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Tooth substrate and storage . 14.1 General . 14.2 Time after extraction . 24.3 Condition of t

16、eeth . 24.4 Initial preparation and storage of teeth 25 Tooth surface preparation 25.1 General . 25.2 Potting (mounting) of teeth . 25.3 Surface preparation 35.4 Storage of prepared specimens 36 Specimen production, handling and storage 36.1 General . 36.2 Preconditioning 36.3 Application of adhesiv

17、e . 36.4 Insertion into bonding clamp . 46.5 Composite placement 46.6 Specimen handling and storage . 47 Notched-edge shear test . 57.1 Apparatus 57.2 Shear loading 67.3 Test 67.4 Recording and treatment of results 67.5 Report . 6Annex A (normative) Detailed drawings of notched-edge shear apparatus

18、. 8BS EN ISO 29022:2013ISO 29022:2013(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 bod

19、y interested in a 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 Electrote

20、chnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by t

21、he technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.ISO 29022 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative mate

22、rials.iv ISO 2013 All rights reservedBS EN ISO 29022:2013ISO 29022:2013(E)IntroductionThe International Organization 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

23、takes no position concerning the evidence, validity and scope of this patent right.The holder of this patent 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 stat

24、ement of the holder of this patent right is registered with ISO. Information may be obtained from:Neil T. Jessop, 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

25、patent rights other than those identified above. ISO shall not be held responsible for identifying any or all 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 me

26、thod described in this International Standard has been used for comparing dental adhesive materials, users 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

27、or preferable, depending on the objective (e.g. academic research). ISO 2013 All rights reserved vBS EN ISO 29022:2013BS EN ISO 29022:2013Dentistry Adhesion Notched-edge shear bond strength test1 ScopeThis International Standard specifies a shear test method used to determine the adhesive bond stren

28、gth 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 substrate selection, storage and handling of tooth structure, as well as the procedure for testing.NOTE 1 Testing adh

29、esion 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 materials (e.g. glass-ionomer materials).2 Normative referencesThe following documents, in whole or in part, are no

30、rmatively 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 amendments) applies.ISO 1942, Dentistry VocabularyISO 3696, Water for analytical

31、 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, the terms and definitions given in ISO 1942 and the following apply.3.1bond strengthforce per unit area required

32、 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 plastic or unset state and sets intraorally when used clinically3.3substratematerial upon the surface of which an a

33、dhesive 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 bond strength. Record the type of substrate used.INTERNATIONAL STANDARD ISO 29022:2013(E) ISO 2013 All rights reserv

34、ed 1BS EN ISO 29022:2013ISO 29022:2013(E)For 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 bonding area.Use superficial dentine, i.e. as clos

35、e 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 Time after extractionUse teeth within 6 months aft

36、er 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-filled teeth (endodontically treated).4.4 Initial

37、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 extraction.Place the teeth in water (ISO 3696, grade 3) a

38、t (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, e.g. aldehydes, or which can inhibit radical poly

39、merization, 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, flat surface is required. Keep tooth surfaces wet

40、 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 opening to the pulp chamber with wax or dental cement

41、. 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 bonding side down (labial side down for bovine teet

42、h; 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 suggested. If rings are used, a sheet of polyester or s

43、imilar 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 set. Store the potted tooth immediately in water (I

44、SO 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.2 ISO 2013 All rights reservedBS EN ISO 29022:2013ISO 29022:2013(E)NOTE 2 It is preferable to pot teeth soon afte

45、r 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 carbide abrasive paper, complying w

46、ith 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 composite (composite) button with a dia

47、meter 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 paper is (35 1) m. If abrasive p

48、apers 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 orientates the abrasive paper perpendi

49、cular 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 motorized 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 spe