《BS-EN-ISO-24234-2004.pdf》由会员分享，可在线阅读，更多相关《BS-EN-ISO-24234-2004.pdf（40页珍藏版）》请在三一文库上搜索。
1、BRITISH STANDARD BS EN ISO 24234:2004 Dentistry Mercury and alloys for dental amalgam The European Standard EN ISO 24234:2004 has the status of a British Standard ICS 11.060.10 ? Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 2423
2、4:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 27 October 2004 BSI 27 October 2004 ISBN 0 580 44662 X National foreword This British Standard is the official English language version of EN ISO 24234:2004. It is identical with ISO 2423
3、4:2004. It supersedes BS EN ISO 1559:2001 and BS 4227:1986 which are withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/106, Dentistry, to Subcommittee CH/106/1, Restorative and orthodontic materials, which has the responsibility to: A list of organizations re
4、presented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence
5、Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of itself
6、confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and prom
7、ulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii to v, a blank page, pages 1 to 28, an inside back cover and a back cover. The BSI copyright notice displayed in this doc
8、ument indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 24234 October 2004 ICS 11.0
9、60.10 Supersedes EN 21560:1991 English version Dentistry - Mercury and alloys for dental amalgam (ISO 24234:2004) Art dentaire - Mercure et alliages pour amalgame dentaire (ISO 24234:2004) Zahnheilkunde - Quecksilber und Legierungen fr zahnrztliche Amalgame (ISO 24234:2004) This European Standard wa
10、s approved by CEN on 16 August 2004. 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 na
11、tional standards may be obtained on application to the Central Secretariat 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
12、notified to the Central Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Net
13、herlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2004 CEN All rights of exploitation in an
14、y form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 24234:2004: E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI I NESO 42:4322004 (E) 2 Foreword This document (EN ISO 24234:2004) has been prepared by Techni
15、cal Committee 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 April
16、 2005, and conflicting national standards shall be withdrawn at the latest by April 2005. This document supersedes EN 21560:1991. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria,
17、 Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Endorsement notice The text of ISO 2
18、4234:2004 has been approved by CEN as EN ISO 24234:2004 without any modifications. EN ISO 24234:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Reference number ISO 24234:2004(E) OSI 4002 INTERNATIONAL STANDARD ISO 24234 First edition 2
19、004-10-15 Dentistry Mercury and alloys for dental amalgam Art dentaire Mercure et alliages pour amalgame dentaire EN ISO 24234:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:43242 O4002(E) DPlcsid Fremia ihTs PDF file mya ctnoian em
20、debt dedyfepcaes. In ccacnadrow eitA hebods licnesilop gnic,y tihs file mirp eb yatnde iv roweb detu slahl ton ide ebtlnu deess teh typfecaes wihce era hml era deddebicsnede ti dna onstlalde t noeh comuptfrep reromign tide ehtin.g In wodlnidaot gnihs fil,e trapise atpecc tiereht nser ehnopsiiblity f
21、o nto ifnriigngn Aebods licnesilop gnic.y ehT ISO tneClar Secrteirata caceptl on siibality in this .aera Ai ebods a tedarmfo kra Aebod SystemI snctaropro.de teDials fo teh sfotwcudorp erats sut deo crtaee tihs PDF file cna f ebi dnuon tlareneG eh Ifnler oatit evt oeh file; tP ehDc-Frtaeino maraptere
22、w stpo ereimizde fro irptni.gn Evyre cera neeb sah takne tsne oeru taht teh file is siutlbae fosu re yb ISO memdob rebeis. In tlnu ehikletneve y ttah lborp aem lertait gno it is f,dnuo plsaee ifnrom ttneC ehlar Secterirata ta teh serddaig sleb nevwo. ISO 4002 All irthgs erse.devr lnUeto sswrehise sp
23、ecified, on trap fo this lbupictaion maeb y cudorperro de tuilizi den yna form ro na ybm ynae,s lecetrinoc ro mceinahcla, incliduntohp gcoiypodna gn micrfoilm, wittuoh repmissii now nritign from ietI rehSa Ot tsserdda eh ebolw or ISOs memreb i ydobn the cnuotfo yr ttseuqer ehe.r ISO cirypothg fofice
24、 saCe tsopale 65 eneG 1121-HC 02 av leT. 4 + 10 947 22 1 11 xaF0 947 22 14 + 9 74 E-mial coirypthgis.o gro We bwww.is.o gro ii ISO 4002 Allr ithgsr esedevr EN ISO 24234:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:43242 O4002(E) I
25、 SO 4002 All irthgs ersedevr iii Contents Page Forewordiv Introduction v 1 Scope1 2 Normative references .1 3 Terms and definitions.2 4 Requirements 3 4.1 General.3 4.2 Chemical composition of the alloy3 4.3 Biocompatibility 4 4.4 Foreign material and large particles in the alloy powder .4 4.5 Conta
26、mination of the mercury 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 setting5 5 Sampling6 6 Test methods.6 6.1 Chemical composition of the alloy6 6.2
27、Foreign material and large particles in the alloy powder .6 6.3 Contamination of the mercury by oil, water or foreign material7 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 requireme
28、nts for creep, 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 setting15 7 Marking, labelling and packaging .16 7.1 Packag
29、ing 16 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 amalgam24 Bibliography .28 Table 1 Requirements for chemical composition of the alloy4 Tabl
30、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 EN ISO 24234:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Unco
31、ntrolled Copy, (c) BSI IS:43242 O4002(E) iv I SO 4002 All irthgs ersedevr 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 te
32、chnical 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 close
33、ly with 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
34、 International 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 docume
35、nt may 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 155
36、9:1995, 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, w
37、hether 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 mercur
38、y from 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
39、packaging 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
40、regional requirements. Procedures for corrosion testing have been added as normative annexes. EN ISO 24234:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI IS:43242 O4002(E) I SO 4002 All irthgs ersedevr v Introduction Dental amalgam all
41、oy and mercury 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
42、 two separate 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 o
43、f dentists 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, thi
44、s is necessary 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 wa
45、s considered, 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 requireme
46、nt for the corrosion resistance will be set and incorporated at the earliest possible date. EN ISO 24234:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:57:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI blank EN ISO 24234:2004 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:5
47、7:23 GMT+00:00 2006, Uncontrolled Copy, (c) BSI INTENRATIONAL TSANDADR IS:43242 O4002(E) I SO 4002 All irthgs ersedevr 1 Dentistry Mercury and alloys for dental amalgam WARNING The use of this International Standard may involve hazardous materials, operations and equipment. This International Standa
48、rd does not purport to address 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 Internat
49、ional Standard specifies the 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 powder compressed to form a tablet, or a powder in predosed capsules. It is applicable to dental m