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1、BRITISH STANDARD BS EN ISO 1559:2001 Incoporating Corrigendum No.1 Dental materials Alloys for dental amalgam The European Standard EN ISO 1559:2001 has the status of a British Standard ICS 11.060.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sh
2、effieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 1559:2001 This British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 O
3、ctober 2001 BSI 29 August 2001 ISBN 0 580 37912 4 National foreword This British Standard is the official English language version of EN ISO 1559:2001. It is identical with ISO 1559:1995 including Technical Corrigendum 1 1997. It supersedes BS EN 21559:1992 which is withdrawn. The UK participation i
4、n its preparation was entrusted to Technical Committee CH/53, Dental restorative and orthodontic materials, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement inter
5、national or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to incl
6、ude all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible European committee
7、any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate 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 fo
8、reword page, the ISO title page, pages ii and iii, a blank page, pages 1 to 7, and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Sidelining in this document indicates the most recent changes by amendment. Amendments issued since publicat
9、ion Amd. No. DateComments 13438 Corrigendum No.1 29 August 2001 Corrections to national foreword and Figure 1 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 1559 July 2001 ICS 11.060.
10、10Supersedes EN 21559:1991 English version Dental materials - Alloys for dental amalgam (ISO 1559:1995 + Technical Corrigendum 1:1997) Produits dentaires - Alliages pour amalgame dentaire (ISO 1559:1995 + Rectificatif technique 1:1997) Zahnrztliche Werkstoffe - Legierungen fr zahnrztliche Amalgame (
11、ISO 1559:1995 + Technische Korrektur 1:1997) This European Standard was approved by CEN on 9 June 2001. 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.
12、 Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the 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 un
13、der the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxe
14、mbourg, Netherlands, Norway, Portugal, 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 2001 CENAll rights of exploitation in any form and by any
15、means reserved worldwide for CEN national Members. Ref. No. EN ISO 1559:2001 E Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of the International Standard from Technical Committee ISO/TC 106 “Dentistry“ of the Internation
16、al Organization for Standardization (ISO) has been taken over as an European Standard by Technical Committee CEN/TC 55 “Dentistry“, the secretariat of which is held by DIN. This European Standard replaces EN 21559:1991. This European Standard shall be given the status of a national standard, either
17、by publication of an identical text or by endorsement, at the latest by January 2002, and conflicting national standards shall be withdrawn at the latest by January 2002. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to i
18、mplement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 1559:1995
19、, including Technical Corrigendum 1:1997 has been approved by CEN as a European Standard without any modification. NOTE Normative references to International Standards are listed in annex ZA (normative). EN ISO 1559:2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006,
20、 Uncontrolled Copy, (c) BSI INTERNATIONAL STANDARD ISO 1559 Third edition 1995-12-15 Dental materials - Alloys for dental amalgam Produits den taires - Alliages pour amalgame dentaire Reference number ISO 1559:1995(E) EN ISO 1559:2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 G
21、MT+00:00 2006, Uncontrolled Copy, (c) BSI OSI )E(5991:9551 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 committ
22、ees. Esch 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 with the Int
23、ernational Electrotechnical Commission (1 EC) on all matters of electrotechnical standardization. Draft 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 membe
24、r bodies casting a vote. International Standard ISO 1559 was prepared by Technical Committee ISOnC 106, Dentistry, Subcommittee SC 1, Filling and restorative ma- terials. This third edition cancels and replaces the second edition (ISO 1559:1986), of which it constitutes a technical revision. (See th
25、e Introduction.) 0 OSI 5991 llA sthgir .devreser sselnU esiwrehto ,deificeps on trap fo siht noitacilbup yam eb decudorper ro dezilitu ni yna mrof ro yb yna ,snaem einortcele ro ,lacinahcem gnidulcni gniypocotohp dna ,mliforcrm tuohtiw noissimreP ni gnitirw morf eht .rehsilbup lanoitanretnI noitazin
26、agrO rof noitazidradnatS esaC elatsoP 65 l l-HC 112 eveneG 02 l dnalreztiwS detnirP ni dnalreztiwS ii EN ISO 1559:2001 ii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 0 OSI OSI )E(5991:9551 Introduction This International Standard was fir
27、st published in 1978 and was based on International Dental Federation (FDI) Specification No. 1. lt was then the subject of a planned Programme of revision, and a second edition was published in 1986. The more significant changes in this third edition are the following. - The requirement for Chemica
28、l composition has been changed. - The procedures for amalgamation have been specified in more detail. - A pass rate rather test requirements. than an average value has been incorporated in the - The requirements for marking of the packages have been extended. - The requirement for dimensional Change
29、 has been revised. - A requirement to limit foreign material in the alloy powder has been added. - The precaution for zinc-containing alloys has been revised. lt is proposed to continue the efforts to include a corrosion test require- ment for dental amalgam at the earliest possible date. EN ISO 155
30、9:2001 iii Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI sihT egap ylianoitnetni tfel knalb EN ISO 1559:2001 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI LANOITANRETNI DRADNATS
31、0 OSI OSI )E(5991:9551 Dental materials - Alloys for dental amalgam 1 Scope 3 Definitions This International Standard specifies requirements and test methods for alloys composed mainly of sil- ver, tin and topper, complying with the composition requirements (see 4.1). The alloy may be in either powd
32、er or tablet form, or in capsules with portions of alloy and mercury predosed by the manifacturer, suitable for the preparation of dental amalgam. For the purposes of this International Standard, the following definitions apply. 3.1 alloy for dental amalgam: Alloy in fine par- ticles, composed mainl
33、y of silver, tin and topper, which, when mixed with mercury, produces a dental amalgam. 2 Normative references The following Standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publi- cation, the editions indicated
34、were valid. All Standards are subject to revision, and Parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most re- cent editions of the Standards indicated below. Members of IEC and ISO maintain registers of cur- rently valid Inte
35、rnational Standards. ISO 78-4:1983, Layouts for Standards - Part 4: Standard for a tomic absorp tion spectrome trk analysis. ISO 286-2: 1988, ISO System of limits and fits - Part 2: Tables of Standard tolerante grades and limit deviations for holes and shafts. ISO 468: 1982, Surface roughness - Para
36、meters, their values and general rules for specifying requke- men ts. ISO 1560: 1985, Dental mercury. ISO 331 O-l :1990, Test sieves - Technical require- ments and testing - Part 7: Test sieves of metal wire clo th. I SO 7488: 199 1, Dental amalgama tors. 3.2 capsulated alloy and mercury: Capsules p
37、re- dosed with alloy and mercury by the manufacturer. 4 Requirements 4.1 Chemical composition 4.1 .l General The Chemical composition of the alloy shall comply with table 1. The total contamination by other elements shall not exceed 0,l % (mlm). Table 1 - Chemical composition requirements Metal Cont
38、ent % (m/m) Siber Tin Copper Indium Palladium Platinum Zinc Mercury 40 min. 32 max. 30 max. 5 max. 1 max. 1 max. 2 max. 3 max. If atomic absorption spectrometry is used for chemi- cal analysis, it shall be carried out in accordance with ISO 78-4. EN ISO 1559:2001 1 Licensed Copy: sheffieldun sheffie
39、ldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI OSI )E(5991:9551 0 OSI 4.1.2 Deviations in Chemical composition Compositions other than those specified in 4.1 .l may be permissible subject to approval by regulatot-y authorities. The silver content shall nevertheless not be l
40、ess than 40 % (mlm). 4.2 Physical properties When tested in accordance with 6.2 to 6.4, the ma- terial shall comply with the requirements given in ta- ble 2. Table 2 - Physical properties Creep % max. 3 Dimensional Change % - 0,15 to + 0,20 Compressive strength after 1 h after 24 h MPa MPa min. min.
41、 50 300 4.5 Foreign material When tested in accordance with 6.7, the alloy shall contain no more than five particles of foreign material. 5 Sampling At least 50 g of alloy of the Same batch in packages produced for retail shall be procured. 6 Test methods 6.1 Preparation of test specimens 4.3 Mass T
42、he coefficient of Variation of the mass of alloy tablets shall not exceed 1,5 % (m/m) and the arithmetic mean of the mass of alloy tablets shall be within + 2 % (m/m) of the manufacturer s stated mass when tested in accordance with 6.5. For capsules containing preproportioned alloy and mercury, the
43、coefficients of Variation of the masses of the alloy and the mercury shall each not exceed 1,5 % (m/m) and the arithmetic means of the masses of both the alloy and the mercury shall each be within + 2 % (m/m) of the manufacturer s stated masses when tested in accordance with 6.5. 4.4 Loss of mercury
44、 Capsules predosed with alloy and mercury by the manufacturer shall meet the following requirements: - the mercury in capsules shall comply with ISO 1560; - the loss in mass for each capsule during amal- gamation shall not exceed 0,5 mg when tested according to 6.6. 6.1 .l Temperature Prepare all te
45、st specimens at (23 + 2) “C. 6.1.2 Amalgamation The mass of the amalgam mix shall be sufficient to make a test cylinder (8 + 1) mm high after conden- sation with a diameter according to figure 1. If necessary, adjust the height of the cyiinder by con- densing only a Portion of the amalgam mix into t
46、he mould. For alloy supplied as tablets or powder, the alloy mass and the mercury mass to be mixed, the capsule (if needed), the pestle (if needed), and any other mixing accessories required shall conform to those recommended by the manufacturer in accord- ante with 7.3.1 and 7.3.2. For capsulated a
47、lloy and mercury, simultaneously amalgamate as many cap- sules as needed. An amalgamator that camplies with ISO 7488 shall be used. The amalgamator s frequency (or machine setting) and the amalgamation time shall be as specified by the manufacturer in accordance with 7.3.2. EN ISO 1559:2001 2 Licens
48、ed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 09:52:20 GMT+00:00 2006, Uncontrolled Copy, (c) BSI OSI )E(5991:9551 0 OSI 6.1.3 Apparatus for preparation of test specimens for determination o
49、f creep, dimensional Change and compressive strength Use an all-mechanical apparatus as shown in figure 1. The holder, spacers and cap need not be hardened; they shall be made of cold-rolled or stainless steel. Make the die and plungers of hardened tool steel or hardened stainless steel. Hone the working surfaces of the die and plungers to a surface roughness value (y,) of not greater than 6,3 Pm when tested in ac- cordante with ISO 468. Limits of clearance between the die and plungers shall be F7/h7 in accordance with ISO 286-2. Assemble the holder, spacers Nos. 1 and 2