BS PD ISO TS 17988-2014 Dentistry Corrosion test methods for dental amalgam《牙科 牙科银汞合金的腐蚀试验方法》.pdf

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1、BSI Standards Publication Dentistry Corrosion test methods for dental amalgam PD ISO/TS 17988:2014National foreword This Published Document is the UK implementation of ISO/TS 17988:2014. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee C

2、H/106/1, Dental restorative and orthodontic materials. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The Br

3、itish Standards Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 78978 6 ICS 11.060.10 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on

4、 30 April 2014. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TS 17988:2014 ISO 2014 Dentistry Corrosion test methods for dental amalgam Mdecine bucco-dentaire Essais de corrosion des amalgames dentaires TECHNICAL SPECIFICATION ISO/TS 17988 First edition

5、 2014-04-01 Reference number ISO/TS 17988:2014(E) PD ISO/TS 17988:2014 ISO/TS 17988:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any

6、means, electronic or mechanical, including photocopying, or posting 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 Case postale 56 CH-1211 Gen

7、eva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland PD ISO/TS 17988:2014 ISO/TS 17988:2014(E) ISO 2014 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4

8、 Sampling 2 5 Preparation of dental amalgam test-pieces . 3 5.1 General . 3 5.2 Cylindrical test-pieces for use in the immersion and potentiostatic corrosion test procedures . 3 5.3 Disc-shaped test-pieces for use in the Hertzian-loading strength-reduction test 7 6 Determination of the resistance to

9、 corrosion by the immersion procedure .9 6.1 Apparatus 9 6.2 Mercury vapour analyser requirements 11 6.3 Reagents for the test solution and cleaning the apparatus11 6.4 Cleaning the glassware 11 6.5 Assembly of the immersion corrosion test apparatus .11 6.6 Test-piece production 12 6.7 Preparation o

10、f the 0,1 mol/l lactic acid solution 12 6.8 Finishing the dental amalgam test-piece.12 6.9 Test procedure 13 6.10 Analysis.14 6.11 Treatment of data and reporting of results .15 7 Determination of the corrosion by the potentiostatic procedure 15 7.1 Test-piece preparation 15 7.2 Corrosion test cell

11、requirements 16 7.3 Reference electrode probe requirements .16 7.4 Potentiostat requirements .17 7.5 Reagents.17 7.6 Preparation of the electrolyte .17 7.7 Test procedure 17 7.8 Data acquisition and processing .17 7.9 Calculation of the total charge transported 18 7.10 Reporting of results .18 8 Det

12、ermination of the resistance to corrosion by the Hertzian-loading strength- reduction procedure . .18 8.1 Reagents.18 8.2 Stock solutions .19 8.3 Test solution (artificial saliva) 19 8.4 Test procedure 20 8.5 Treatment of data and reporting of results .21 Bibliography .23 PD ISO/TS 17988:2014 ISO/TS

13、 17988:2014(E) Foreword ISO (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 subjec

14、t 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 (IEC)

15、 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 be no

16、ted. 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 elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifyin

17、g 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 (see www.iso.org/patents). Any trade name used in this document is information given for the convenience

18、of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supp

19、lementary information The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This is the first edition of ISO/TS 17988, Dentistry Corrosion test methods for dental amalgam. Part of the subject matter in this Technical Specification

20、 was formerly contained in two annexes to ISO 24234:2004, Dentistry Mercury and alloys for dental amalgam.iv ISO 2014 All rights reserved PD ISO/TS 17988:2014 ISO/TS 17988:2014(E) Introduction Dental amalgam alloy and dental mercury are the essential and only components of dental amalgam restorative

21、 material. This Technical Specification, of which this is the first edition, gives the practical details of three test methods for the measurement of the resistance to corrosion of dental amalgam. These corrosion test methods are laboratory procedures for evaluating the relative performances of dent

22、al amalgam alloy products. They are designed to produce a measurable effect (and differences between products) within a relatively short time period, a time period appropriate for a comparative laboratory evaluation. The results of these tests are not intended to be used directly for any biocompatib

23、ility claims, for which their use is inappropriate. Should other corrosion test procedures emerge as suitable for application to dental amalgam and use in the comparative evaluations of products, they will be included in future editions of this Technical Specification. ISO 2014 All rights reserved v

24、 PD ISO/TS 17988:2014 Dentistry Corrosion test methods for dental amalgam 1 Scope This Technical Specification gives details of test procedures for evaluating the corrosion resistance of dental amalgam produced from a dental amalgam alloy product. It is applicable to dental amalgam formed from produ

25、cts that are within the scope of ISO 24234, Dentistry Dental amalgam. It is not applicable to dental metallic materials that are within the scope of ISO 22674, Dentistry Metallic materials for fixed and removable restorations and appliances. This Technical Specification is not applicable to metallic

26、 materials in which an alloy powder reacts with a liquid alloy to produce a solid metallic material intended for dental restoration. NOTE Dental mercury is at least 99,99 % pure, and as such it is a metallic element of high commercial purity, and not an alloy. 2 Normative references The following do

27、cuments, 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 referenced document (including any amendments) applies. ISO 286-2, Geometrical

28、product specifications (GPS) ISO code system for tolerances on linear sizes Part 2: Tables of standard tolerance classes and limit deviations for holes and shafts ISO 1942, Dentistry Vocabulary ISO 3585, Borosilicate glass 3.3 Properties ISO 3696, Water for analytical laboratory use Specification an

29、d test methods ISO 6344-1, Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO 7488, Dental amalgamators ISO 13565-2, Geometrical Product Specifications (GPS) Surface texture: Profile method; Surfaces having stratified functional properties Part 2: Height characterization u

30、sing the linear material ratio curve ISO 13897, Dentistry Amalgam capsules ISO 24234, Dentistry Dental amalgam 3 T erms a nd definiti ons For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 dental amalgam alloy alloy in fine particles, composed

31、 mainly of silver, tin and copper, which when mixed with dental mercury produces a dental amalgam for dental restoration TECHNICAL SPECIFICATION ISO/TS 17988:2014(E) ISO 2014 All rights reserved 1 PD ISO/TS 17988:2014 ISO/TS 17988:2014(E) 3.2 dental mercury mercury supplied for use in the preparatio

32、n of dental amalgam 3.3 pre-capsulated product product supplied in a sealed capsule that contains measured amounts of dental amalgam alloy powder and dental mercury with masses that are appropriate for the production of a mass of dental amalgam that is considered to be suitable for a single small or

33、 medium size restoration in a single tooth Note 1 to entry: The dental amalgam alloy powder and dental mercury are separated by a barrier that is broken immediately prior to mixing, allowing their contact. The capsule remains sealed until mixing has been completed. 3.4 dental amalgam alloy tablet qu

34、antity of dental amalgam alloy powder that has been compressed to form a single entity for the purpose of providing a pre-dosed quantity of the alloy that, when mixed with an appropriate mass of dental mercury, produces a mass of dental amalgam that is considered to be suitable for a single small or

35、 medium size restoration in a single tooth Note 1 to entry: During mixing the tablet is intended to break apart, forming a fine powder. 3.5 dental mercury sachet measured quantity of dental mercury supplied in a sachet (for use in a reusable mixing capsule) in a mass that, when mixed with an appropr

36、iate mass of dental amalgam alloy, produces a mass of dental amalgam that is considered to be suitable for a single small or medium size restoration in a single tooth Note 1 to entry: The sachet is intended to rupture during mixing to allow the dental mercury to come into contact with the dental ama

37、lgam alloy powder. 3.6 immersion corrosion test test in which a test-piece of known surface area is immersed in a specified solution (at a specified temperature) for a defined period of time to determine quantitatively the elemental release into the solution and thereby allow a comparison of the cor

38、rosion resistance between this and other products of a similar type Note 1 to entry: For the present case of dental amalgam, the mercury released as vapour is also relevant. 3.7 potentiostatic corrosion test test in which a test-piece of known surface area is immersed in a specified electrolyte (at

39、a specified temperature) with a set potential applied for a defined period of time during which the corrosion current is recorded, integrated and then normalized by the anodic surface area and time to produce the total charge transported per unit of area in a unit of time, expressed in C/(cm 2 d) 3.

40、8 Hertzian-loading strength-reduction corrosion test test in which a test-piece is immersed for a defined period of time in a specified solution (at a specified temperature) in a way that creates crevice corrosion conditions on one surface, after which it is removed from the solution and fractured w

41、ith the force to do this then compared with the force to fracture an identical test-piece subjected to ageing in air at the same temperature Note 1 to entry: Fracture is initiated from the surface subjected to crevice corrosion conditions and proceeds by radial crack growth. 4 Sampling All products

42、shall be procured in packages that have been produced for retail.2 ISO 2014 All rights reserved PD ISO/TS 17988:2014 ISO/TS 17988:2014(E) For pre-capsulated products, all capsules shall be of the same lot. For a free-flowing dental amalgam alloy powder in bulk, or dental amalgam alloy tablets, the a

43、lloy shall be from a single lot. For use with these, the dental mercury sachets shall be from a single lot that complies with ISO 24234. (Use as many dental mercury sachets as required, according to the mixing ratio recommended by the manufacturer of the dental amalgam alloy product.) For the immers

44、ion corrosion procedure (Clause 6) at least 3 g of dental amalgam alloy is required. For the potentiostatic corrosion procedure (Clause 7) at least 1 g of dental amalgam alloy is required. For the Hertzian-loading strength-reduction procedure (Clause 8), at least 35 g of dental amalgam alloy is requ

45、ired. 5 Preparation of dental amalgam test-pieces 5.1 General 5.1.1 Temperature Prepare test-pieces at (23 2) C. 5.1.2 Mixing For a dental amalgam alloy product supplied either as tablets or as a free-flowing powder in bulk, the ratio by mass of the dental amalgam alloy to the dental mercury should

46、be that recommended by the manufacturer. Use a capsule (with a pestle, if needed) that complies with ISO 13897. Use any other mixing accessory that is required, as recommended by the manufacturer. If more than one mix is required to make the test-piece, produce these mixes simultaneously using equip

47、ment of the same type for each mix. However, if the last mix can be produced within the working time of the first mix, mixing these masses sequentially on a single piece of equipment is allowed. For pre-capsulated products, use as many capsules as needed. Mix the contents of the capsules either simu

48、ltaneously using the same number of pieces of equipment of the same type, or sequentially on a single piece of equipment. (The latter is allowed, provided the mixing of the last capsule is completed before the end of the working time of the first.) If necessary, use only a portion of the dental amal

49、gam mix from one of these capsules. Use an amalgamator that complies with ISO 7488 and that is recommended for mixing the amalgam alloy product with dental mercury or mixing the pre-capsulated product. Use the amalgamator setting and mixing time that is recommended by the manufacturer of the dental amalgam alloy or pre-capsulated product (for the mass of dental amalgam alloy that is being mixed). 5.2 Cylindrical test-pieces for use in the immersion and potentiostatic corrosion test procedures 5.2.1 Mixing Mix a mas