SANS 24234-2008 Dentistry - Mercury and alloys for dental amalgam《牙科 牙科银汞合金用汞及其合金》.pdf

1、 Collection of SANS standards in electronic format (PDF) 1. Copyright This standard is available to staff members of companies that have subscribed to the complete collection of SANS standards in accordance with a formal copyright agreement. This document may reside on a CENTRAL FILE SERVER or INTRA

2、NET SYSTEM only. Unless specific permission has been granted, this document MAY NOT be sent or given to staff members from other companies or organizations. Doing so would constitute a VIOLATION of SABS copyright rules. 2. Indemnity The South African Bureau of Standards accepts no liability for any

3、damage whatsoever than may result from the use of this material or the information contain therein, irrespective of the cause and quantum thereof. ISBN 978-0-626-21887-4 SANS 24234:2008Edition 1ISO 24234:2004Edition 1SOUTH AFRICAN NATIONAL STANDARD Dentistry Mercury and alloys for dental amalgam Thi

4、s national standard is the identical implementation of ISO 24234:2004 and is adopted with the permission of the International Organization for Standardization. Published by SABS Standards Division 1 Dr Lategan Road Groenkloof Private Bag X191 Pretoria 0001Tel: +27 12 428 7911 Fax: +27 12 344 1568 ww

5、w.sabs.co.za SABS SANS 24234:2008 Edition 1 ISO 24234:2004 Edition 1 Table of changes Change No. Date Scope National foreword This South African standard was approved by National Committee SABS TC 1078, Engineering materials Non-ferrous metals, in accordance with procedures of the SABS Standards Div

6、ision, in compliance with annex 3 of the WTO/TBT agreement. This SANS document was published in October 2008. This SANS document supersedes SABS/ISO 1559:1995 (first edition). Reference numberISO 24234:2004(E)ISO 2004INTERNATIONAL STANDARD ISO24234First edition2004-10-15Dentistry Mercury and alloys

7、for dental amalgam Art dentaire Mercure et alliages pour amalgame dentaire SANS 24234:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 24234:2004(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes

8、 licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobes licensing policy. T

9、he ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care h

10、as been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2004 All rights reserved. Unless otherwise specified, no part of this publication may be

11、 reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing 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 Geneva 20 Tel. + 4

12、1 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2004 All rights reservedSANS 24234:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 24234:2004(E) ISO 2004 All rights reserved

13、 iiiContents Page Foreword iv Introduction v 1 Scope 1 2 Normative references . 1 3 Terms and definitions. 2 4 Requirements 3 4.1 General. 3 4.2 Chemical composition of the alloy 3 4.3 Biocompatibility 4 4.4 Foreign material and large particles in the alloy powder . 4 4.5 Contamination of the mercur

14、y by oil, water and foreign material . 4 4.6 Purity of mercury Free pouring. 4 4.7 Variability of preproportioned masses . 4 4.8 Properties of the amalgam. 5 4.9 Appearance of the mixed amalgam before setting 5 5 Sampling 6 6 Test methods. 6 6.1 Chemical composition of the alloy 6 6.2 Foreign materi

15、al and large particles in the alloy powder . 6 6.3 Contamination of the mercury by oil, water or foreign material 7 6.4 Free-pouring of mercury 8 6.5 Determination of the variability of preproportioned masses . 8 6.6 Preparation of test specimens to determine compliance with the requirements for cre

16、ep, dimensional change and compressive strength . 9 6.7 Determination of creep. 14 6.8 Determination of dimensional change during hardening. 14 6.9 Determination of compressive strength.15 6.10 Appearance of the mixed amalgam before setting 15 7 Marking, labelling and packaging . 16 7.1 Packaging 16

17、 7.2 Marking. 16 7.3 Manufacturers instructions. 17 Annex A (normative) Determination of immersion corrosion for dental amalgam . 19 Annex B (normative) Potentiostatic determination of corrosion for dental amalgam 24 Bibliography . 28 Table 1 Requirements for chemical composition of the alloy 4 Tabl

18、e 2 Properties of amalgam 5 Table 3 Schedule for the preparation of test specimens 13 Table B.1 Potential settings for different reference electrodes and temperatures of the reference electrodes. 27 SANS 24234:2008This s tandard may only be used and printed by approved subscription and freemailing c

19、lients of the SABS .ISO 24234:2004(E) iv ISO 2004 All rights reservedForeword 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 technic

20、al 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 take part in the work. ISO collaborates closely wi

21、th the International Electrotechnical 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 Inte

22、rnational Standards adopted by the 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. Attention is drawn to the possibility that some of the elements of this document ma

23、y be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 24234 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and restorative materials. This International Standard cancels and replaces ISO 1559:199

24、5, ISO 1559:1995/Cor.1:1997 and ISO 1560:1985. A number of technical revisions have been made as improvements or as a consequence of combining the International Standards that have been replaced. The scope of this International Standard applies to alloys for dental amalgam and dental mercury, whethe

25、r provided individually or together. The clause permitting a deviation in the composition of alloys for amalgam has been removed. Guidance on biocompatibility assessment has been introduced. A limit on the presence of large alloy particles has been introduced. The requirement for loss of mercury fro

26、m predosed capsules has been removed, since it is a requirement in ISO 13897. The values for the requirements on creep, dimensional change and compressive strength at 1 h have been revised. The criterion for compliance with the compressive strength requirements has been revised. Provisions for packa

27、ging and marking have been revised. Markings required for mercury safety warnings and precautions have been revised to conform to ISO requirements and the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS). They are no longer dependent upon national or regio

28、nal requirements. Procedures for corrosion testing have been added as normative annexes. SANS 24234:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 24234:2004(E) ISO 2004 All rights reserved vIntroduction Dental amalgam alloy and merc

29、ury are the essential and only components of dental amalgam restorative material. This International Standard combines the requirements and the test methods for the alloy with those for the mercury in a single standard, of which this is the first edition. Formerly, these were contained in two separa

30、te standards. Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this International Standard, but it is recommended that, in assessing possible biological hazards, reference be made to ISO 10993-1 and ISO 7405. To enhance the safety of dentists

31、and support staff, it would have been preferred to limit the scope solely to the use of predosed capsules of alloy and mercury. It is, however, recognised and accepted that both amalgam alloy and mercury are supplied in bulk form in some parts of the world where, for economic reasons, this is necess

32、ary for the provision of dental treatment. Therefore requirements for these products are included in this International Standard. Safety precautions relating to marking, labelling and packaging have been strengthened in this revision. Inclusion of a requirement for corrosion resistance was considere

33、d, using the procedures for corrosion testing given in ISO/TS 17576. However it was decided that the data available were insufficient to justify a corrosion requirement in this International Standard, and as a consequence the test methods alone are given, as normative annexes. A requirement for the

34、corrosion resistance will be set and incorporated at the earliest possible date. SANS 24234:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .SANS 24234:2008This s tandard may only be used and printed by approved subscription and freemailin

35、g clients of the SABS .INTERNATIONAL STANDARD ISO 24234:2004(E) ISO 2004 All rights reserved 1Dentistry Mercury and alloys for dental amalgam WARNING The use of this International Standard may involve hazardous materials, operations and equipment. This International Standard does not purport to addr

36、ess all of the safety problems associated with its use. It is the responsibility of the user of this International Standard to establish appropriate safety and health practices and to determine the applicability or regulatory limitations prior to use. 1 Scope This International Standard specifies th

37、e requirements and test methods for alloys and for mercury suitable for the preparation of dental amalgam, together with the requirements and test methods for that amalgam and the requirements for packaging and marking. It is applicable to alloys supplied in the form of either a powder in bulk, or a

38、 powder compressed to form a tablet, or a powder in predosed capsules. It is applicable to dental mercury supplied either in bulk quantities, or in predosed sachets, or in predosed capsules. This International Standard does not exclude the supply of alloy or mercury separately. This International St

39、andard is not applicable to alloys intended for use with liquid metals that are not mercury, nor is it applicable to liquid metal alloys. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited app

40、lies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 286-2, ISO system of limits and fits Part 2: Table of standard tolerance grades and limit deviations for holes and shafts ISO 3310-1, Test sieves Technical requirements for testing Par

41、t 1: Test sieves of metal wire cloth ISO 3585, Borosilicate glass 3.3 Properties ISO 3696:1987, Water for analytical laboratory use Specification and test methods ISO 3864-2, Graphical symbols Safety colours and safety signs Part 2: Design principles for product safety labels ISO 4793:1980, Laborato

42、ry sintered (fritted) filters Porosity grading, classification and designation ISO 6344-1:1998, Coated abrasives Grain size analysis Part 1: Grain size distribution test ISO 7488, Dental amalgamators SANS 24234:2008This s tandard may only be used and printed by approved subscription and freemailing

43、clients of the SABS .ISO 24234:2004(E) 2 ISO 2004 All rights reservedISO 8282, Dental equipment Mercury and alloy mixers and dispensers ISO 13565-2, Geometrical Product Specifications (GPS) Surface texture: Profile method; Surfaces having stratified functional properties Part 2: Height characterizat

44、ion using the linear material ratio curve ISO 13897, Dentistry Amalgam capsules Globally Harmonized System of Classification and Labelling of Chemicals (GHS). United Nations, New York and Geneva, 2003, ISBN 92-1-116840-6 3 Terms and definitions For the purposes of this document, the following terms

45、and definitions apply. 3.1 alloy for dental amalgam alloy in fine particles, composed mainly of silver, tin and copper, which when mixed with mercury produces a dental amalgam 3.2 predosed capsule capsule, as-supplied, containing measured amounts of alloy powder and mercury for dental amalgam, separ

46、ated in such a way that premature combination is prevented NOTE The separating barrier is broken immediately prior to mixing or breaks during mixing, allowing the alloy and mercury to come into contact. 3.3 amalgam alloy tablet quantity of dental amalgam alloy powder that has been compressed to form

47、 a single entity for the purpose of providing a predosed quantity of the alloy. NOTE During mixing, the tablet is intended to break apart, forming a fine powder. 3.4 tailing phenomenon which occurs when mercury that contains impurities moves over a clean surface, tending to leave behind a portion of

48、 the liquid, forming an elongated tail as if it were sticking to that surface 3.5 primary container container or package that is in direct contact with the material 3.6 dental mercury sachet measured quantity of dental mercury supplied in a sachet that is suitable for a reusable mixing capsule NOTE

49、The sachet is broken immediately prior to mixing, or breaks during mixing, allowing the mercury to come into contact with the alloy SANS 24234:2008This s tandard may only be used and printed by approved subscription and freemailing clients of the SABS .ISO 24234:2004(E) ISO 2004 All rights reserved 34 Requirements 4.1 General 4.1.1 If the alloy is supplied as a powder in bulk, the product shall comply with requirements 4.2, 4.3, 4.4, 4.8, 4.9, and packaging requirement 7.1, and