ISO TS 19736-2017 Dentistry - Bonding test between polymer teeth and denture base materials.pdf

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1、 ISO 2017 Dentistry Bonding test between polymer teeth and denture base materials Mdecine bucco-dentaire Test dadhsion entre des dents en polymre et le polymre pour base de prothse TECHNICAL SPECIFICATION ISO/TS 19736 Reference number ISO/TS 19736:2017(E) First edition 2017-09 ISO/TS 19736:2017(E)ii

2、 ISO 2017 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

3、 on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the country of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41

4、22 749 09 47 copyrightiso.org www.iso.org ISO/TS 19736:2017(E)Foreword iv 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Bond between polymer teeth and denture base materials 1 4.1 General . 1 4.2 Apparatus and materials 2 5 Procedure. 3 5.1 Preparation of test specimen 3 5.2 Te

5、st procedure . 4 5.3 Evaluation 4 6 Test report . 5 ISO 2017 All rights reserved iii Contents Page ISO/TS 19736:2017(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International St

6、andards 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 organizations, governmental and non-governmental, in liaison with ISO, also

7、 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 further maintenance are described in the ISO/IEC Directives, Part 1. I

8、n 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/directives). Attention is drawn to the possibility that some of the elemen

9、ts 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 the Introduction and/or on the ISO list of patent declarations received

10、(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 voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as we

11、ll as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html. This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials.i

12、v ISO 2017 All rights reserved TECHNICAL SPECIFICATION ISO/TS 19736:2017(E) Dentistry Bonding test between polymer teeth and denture base materials 1 Scope This document specifies a test method for bonding of polymer teeth to denture base materials. This test method is not designed to prove the prop

13、erties of polymer teeth and denture base materials. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the

14、latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry Vocabulary ISO 6873, Dentistry Gypsum products ISO 7500-1, Metallic materials Calibration and verification of static uniaxial testing machines Part 1: Tension/compression testing machines Calibration an

15、d verification of the force-measuring system ISO 20795-1, Dentistry Base polymers Part 1: Denture base polymers ISO 22112:2017, Dentistry Artificial teeth for dental prostheses 3 T erms a nd definiti ons For the purposes of this document, the terms and definitions given in ISO 1942, ISO 20795-1 and

16、the following apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at http:/ /www.electropedia.org/ ISO Online browsing platform: available at http:/ /www.iso.org/obp 3.1 adhesive fracture fracture at the interface be

17、tween the polymer tooth and the denture base materials 3.2 cohesive fracture fracture in the body of the polymer tooth or the denture base materials 3.3 polymer teeth artificial teeth made from polymer material 4 Bond between polymer teeth and denture base materials 4.1 General This test method inve

18、stigates the bonding of polymer teeth to denture-base materials. ISO 2017 All rights reserved 1 ISO/TS 19736:2017(E) This test method examines the bonding behaviour along the bonding surface. A measurement of the bond strength of polymer teeth to denture base material is only meaningful if the fract

19、ure is at least partially adhesive, i.e. progresses along the bonding surface. This test method is not designed to prove the properties of the polymer teeth and the denture base materials. 4.2 Apparatus and materials The following apparatus and materials are required for production of the test speci

20、mens (see Figure 2): 4.2.1 Addition-cured polyvinyl siloxane, for making a silicone mould (Figure 3) to produce test specimens. 4.2.2 Modelling wax, for production of a cylindrical wax body (see Figure 2). 4.2.3 Dental laboratory processing apparatus/instrument, applicable to the denture base materi

21、al. 4.2.4 Denture-base material, applicable types in accordance with ISO 20795-1. 4.2.5 Maxillary anterior polymer teeth, with a crown-width of 8-9 mm, a length of 10-11 mm (including the neck) and an adhesion interface about 45 mm 2 (see Figure 1), in accordance with ISO 22112. 4.2.6 Dental gypsum,

22、 Type 2 or Type 3, in accordance to ISO 6873. 4.2.7 Water bath(s), capable of being maintained at (70 3) C and at boiling water temperature. 4.2.8 Pressure polymerization vessel. 4.2.9 Timer, accurate to 1 s. 4.2.10 Microscope, with 10 magnification. 4.2.11 Mounting device, for mounting cylindrical

23、test specimen as illustrated in Figure 4 to fix test specimens vertical to the shear pin of the testing apparatus. Use a mounting devise with guided shear-pin. 4.2.12 Universal testing machine with built-in load cell, for measuring forces between 10 N and 1000 N. The load cell shall have a measuring

24、 inaccuracy of 1 % of the fracture force in accordance with ISO 7500-1, Class 1. 4.2.13 C y lindrical flat she ar pin, with a diameter of 4 mm.2 ISO 2017 All rights reserved ISO/TS 19736:2017(E) Dimensions in millimetres Figure 1 Tooth size 5 Procedure 5.1 Preparation of test specimen The preparatio

25、n of test specimen can be made from prepolymerized materials by other techniques as recommended from the manufacturer, e.g. milling, injection moulding. All polymer teeth shall be adapted for bonding with applicable types of denture-base polymers in accordance with ISO 20795-1. If there are problems

26、 of achieving bonding, the manufacturers instruction shall contain information about special treatments necessary to achieve bonding and any applicable limitations. Take six maxillary central incisors (Type 1 in accordance with ISO 22112) with at least two different moulds. Using modelling wax, fast

27、en a central incisor vertically to its axis to a cylinder of wax of dimensions h = 20 mm, diameter = 25 mm, extending the modelling wax to 1 mm above the neck of the tooth (see Figure 2). Prepare a mould of the assembly using addition-cured polyvinyl siloxane (silicone) impression material (see Figu

28、re 3). For other incisors of the same dimension, use the silicone mould prepared as above. Place the incisor in the mould and fill the mould with either wax (for specimen production with denture base polymer Type 1) or autopolymerising acrylic resin (for specimen production with denture base polymer

29、 Type 2). Figure 2 Test specimen made from modelling wax and polymer tooth ISO 2017 All rights reserved 3 ISO/TS 19736:2017(E) Figure 3 Silicone mould for production of the test specimens Use a denture flask (4.2.3) for specimen production with denture base polymer Type 1, and set the mounted teeth

30、in dental gypsum (See 4.2.6). Remove the metal form and then flush the wax from the teeth with boiling tap-water. Prepare and process the denture base polymer to the teeth in accordance with the manufacturers instructions. 5.2 Test procedure Fix the polymer-mounted teeth in a mounting device (4.2.11

31、). Use a universal testing machine (4.2.12) with a cylindrical flat shear pin (4.2.13) for the application of the load (see Figure 4). Use a guided shear-pin. The load direction shall be on the palatal surface of the polymer tooth, vertical (approx. 90) to the long axis of the tooth. The shear pin s

32、hall with half of its area contact and apply the load on the incisal edge of the tooth. The test equipment shall prevent any lateral deflection or change of position of the specimen. Apply a crosshead speed of 1 mm/min until the specimen fractures. Figure 4 Application of load to the specimen 5.3 Ev

33、aluation Examine the fracture surfaces under a microscope with 10 magnification.4 ISO 2017 All rights reserved ISO/TS 19736:2017(E) If the fracture path runs cleanly along the interface between teeth and base material it is an adhesive fracture. If the fracture path does not run cleanly along the in

34、terface between tooth and base material it is a cohesive fracture. This means tooth remnants remain bonded to the denture base polymer or there are remnants of denture base polymer remaining bonded to the tooth. If the fracture path is partially adhesive and cohesive it is a mixed fracture. NOTE 1 C

35、ohesive fracture in either the tooth or the denture base material is necessary for a satisfactory bond. Determine the mode of bond failure for each specimen as adhesive fracture or cohesive fracture or mixed fracture (see Figure 5). a) adhesive fracture b) cohesive fracture c) mixed fracture Figure

36、5 Pictures of failure mode The sample passes the test successfully if it shows a cohesive or mixed fracture. Evaluate the fracture behaviour for all test specimens. If four out of six specimens show a cohesive or mixed fracture the bond passes the test. Report the failure mode. 6 Test report The tes

37、t report shall include at least the following items: a) complete identification of the tested polymer teeth, including name, manufacturer, article number, batch number; b) complete identification of the tested denture base material, including name, manufacturer, article number, batch number, and typ

38、e of tested denture base material in accordance with ISO 20795-1; c) processing conditions for specimen preparation; d) number of tested specimens; e) number of teeth within the different categories (adhesive, cohesive, mixed); f) conclusions of the test; g) any circumstances or conditions thought l

39、ikely to affect the results or their validity; h) any deviation from the test method specified; i) reference to this document, i.e. ISO 19736; j) name of the responsible person and the testing laboratory; k) all details necessary to identify the person who carried out the test and the examiner; l) dates of the test period; ISO 2017 All rights reserved 5 ISO/TS 19736:2017(E) m) observations of the examiner; n) date of test report; o) signature of responsible person.6 ISO 2017 All rights reserved ISO/TS 19736:2017(E) ISO 2017 All rights reserved IC S 97.170 Price based on 6 pages