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1、INTERNATIONAL STANDARD IS0 6871 -2 First edition AMENDMENT 1 1994-09-1 5 2005-07-01 Dental base metal casting alloys - Part 2: N ickel-based alloys AMENDMENT 1 Alliages dentaires non prcieux couler - Partie 2 : Alliages base de nickel AMENDEMENT 1 Reference number IS0 6871-2:1994/Amd.l:2005(E) IS0 2
2、005 IS0 6871-2:1994/Amd.l:2005(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobes 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 e
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5、at the address given below. O IS02005 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IS0 at the address b
6、elow or ISOs member body in the country of the requester. IS0 copyright office Case postale 56 CH-I21 1 Geneva 20 Tel. + 41 22 749 O 1 11 Fax +41227490947 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii O IS0 2005 -All rights reserved -,-,- IS0 6871 -2:1994/Amd.l:2005(E) Foreword
7、 IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 technical committees. Each member body interested in a subject for which a technical
8、 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. IS0 collaborates closely with the International Electrotechnical Commission (I EC) on all matters of ele
9、ctrotechnical 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 International Standards adopted by the technical committees are circulated to th
10、e 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 may be the subject of patent rights. IS0 shall not be held responsible for ide
11、ntifying any or all such patent rights. Amendment 1 to IS0 6871 -2: 1994 was prepared by Technical Committee ISOTC 106, Denfisfry, Subcommittee SC 2, frosfhodontic materials. O IS0 2005 -All rights reserved iii -,-,- -,-,- IS0 6871 -2:1994/Amd.l:2005(E) Dental base metal casting alloys - Part 2: N i
12、c kel -based al I oys AMENDMENT 1 Page iv, introduction Replace the text in the Introduction with the following text: “Dental base metal casting alloys are suitable for use in fabrication of removable dental appliances. Specific qualitative and quantitative requirements of freedom from biological ha
13、zards are not included in this part of IS0 6871 but when assessing possible biological or toxicological hazards, it is recommendable to refer to IS0 7405 and IS0 10993-1. For other compositions, the manufacturer has to present adequate evidence of biological investigations in accordance with IS0 740
14、5 or IS0 10933-1, and/or clinical investigations in order to assess the biological response of the material. Specific quantitative requirements for corrosion resistance are not included in this part of IS0 6871. In order to obtain information on the kind and amount of metal ions leached from the all
15、oy, see IS0 10271, and the static immersion test, described in Annex A.” Page 1, Clause 2 Replace the following normative references with the latest editions: “IS0 6892: 1998, Metallic materials - Tensile testing at ambient temperature ASTM B600-9 1 (2002), Standard guide for descaling and cleaning
16、titanium and titanium alloy surfaces” Page 1, subclause 4.1 Replace subclause 4.1 with the following text: “The chemical composition of the casting alloy shall meet the following requirements: Nickel main constituent Chromium 20 % mass fraction 111 Molybdenum 4 % (mass fraction) Cobalt + nickel + ch
17、romium 85 % (mass fraction) 1) The unit (mlm) is deprecated. In accordance with IS0 31-0:1992, 2.3.3, Note 4, the correct expression is mass fraction. O IS0 2005 -All rights reserved 1 -,-,- IS0 6871-2:1994/Amd.l:2005(E) The alloy shall not contain more than 0,02 % (mass fraction) of beryllium. Cons
18、tituents of the alloy in excess of 20 % (mass fraction) shall be within 2 % (mass fraction) of the value stated see Clause 8 b) and 9.2 d). Constituents in excess of 2 % (mass fraction) but not in excess of 20 % (mass fraction) shall be within 1 % (mass fraction) of the value stated see Clause 8 b)
19、and 9 d). The percentage of nickel shall not be greater than the percentage indicated on the package label or insert (see Clause 8). Page 3, Clause 8 b) Replace Clause 8 b) with the following text: “b) a list of all elements present in concentrations equal to or greater than 0,l % (mass fraction), a
20、nd their percentage concentration (mass fraction) if present in concentrations equal to or greater than 2 %.” Pages 3 and 4, Clause 8, last paragraph Replace the last paragraph of Clause 8 with the following text: “As the alloy contains nickel, this shall be clearly stated on the package.” Page 4, s
21、ubclause 9.2 g) Replace subclause 9.2 g) with the following text: “g) a WARNING that the alloy contains nickel and, if it contains any other hazardous element, the warning shall identify the elements and state the percentage (mass fraction) in which they are present.” Page 6, Annex B Delete Annex B.
22、 Page 7, Annex C Delete “Annex C (informative)” so that it reads simply “Bibliography” Replace the following references with the latest editions: I IS0 1942, Dentistry - Vocabulary2) 2 IS0 7405: 1997, Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test
23、methods for dental materials 3 IS0 10271 :2001, Dental metallic materials - Corrosion test methods 4 IS0 10993-1 :2003, Biological evaluation of medical devices - Part 7: Evaluation and testing 2) To be published. (Revision of IS0 1942-1:1989, IS0 1942-2:1989, IS0 1942-3:1989, IS0 1942-4:1989 and IS
24、0 1942-5:1989) 2 O IS0 2005 -All rights reserved -,-,- -,-,- IS0 6871-2:1994/Amd.l:2005(E) ICs 11.060.10 Price based on 2 pages O IS0 2005 -All rights reserved IS0 b87L PT*2 94 H 4851903 0576668 990 H I NTERNAT I O NAL STANDARD IS0 687 1-2 First edition 1994-09-1 5 Dental base metal casting alloys -
25、 Part 2: N ic kel-based alloys Alliages dentaires non prcieux couler - Partie 2: Alliages base de nickel Reference number IS0 6871-2:1994(E) -,-,- IS0 6873 PT*2 94 4853903 0576667 827 IS0 687 1-2:1994(EI Contents Page 1 Scope 1 2 Normative references . 1 3 Definitions . 1 4 Requirements 1 5 Sampling
26、 2 6 Preparation of test specimens 2 7 Testing . 3 8 Information and instructions . 3 9 Marking 4 Annexes A Static immersion test . 5 B Recommendations for handling alloys containing beryllium . 6 C Bibliography 7 Q IS0 1994 All rights reserved. Unless otherwise specified, no part of this publicatio
27、n may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case Postale 56 CH-121 1 Genve 20 Switzerland Printed in Switzerland ii -,-,-
28、IS0 b87L PT*Z 94 4653903 057bb70 549 = 0 IS0 IS0 687 1 -2:1994(E) Foreword IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing international Standards is normally carried out through IS0 technical
29、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. IS0 collaborates closely with
30、the International Eiectrotechnical Commission (IEC) 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 YO of th
31、e member bodies casting a vote. International Standard IS0 6871-2 was prepared by Technical Committee ISOflC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials. This first edition of IS0 6871-2, together with IS0 6871-1, cancel and re- place the first edition of IS0 6871 published in 1987, o
32、f which they con- stitute a technical revision. IS0 6871 consists of the following parts, under the general title Dental base metal casting alloys: - Part 1: Cobalt-based alloys - Part 2: Nickel-based alloys Annex A forms an integral part of this part of IS0 6871. Annexes B and C are for information
33、 only. . 111 IS0 6871 PT*2 74 = 4853703 0576673 485 IS0 6871-2:1994(E) Q IS0 Introduction Dental base metal casting alloys are suitable for use in fabrication of re- movable dental appliances. Specific qualitative and quantitative requirements of freedom from bio- logical hazard are not included in
34、this part of IS0 6871 but it is rec- ommended that, in assessing possible biological or toxicological hazards, reference should be made to ISO/TR 740521 and IS0 10993-1 4. For other compositions the manufacturer has to present adequate evi- dence of biological investigations in accordance with ISO/T
35、R 7405 or IS0 10993-1, and/or clinical investigations in order to assess the biological response of the material. Specific quantitative requirements for corrosion resistance are not in- cluded in this part of IS0 6871. In order to get information of the kind and amount of metal ions leached from the
36、 alloy, reference should be made to ISOITR 1027131, reference number 14, Static immersion test, de- scribed in annex A. Beryllium is considered to be hazardous in handling unless adequate pre- cautions are met. Annex B contains those recommended precautions which are known to be adequate at the time
37、 of publication of this part of IS0 6871. iv INTERNATIONAL STANDARD Q IS0 IS0 687 1 -2:1994(E) Dental base metal casting alloys - Part 2: Nickel-based alloys 1 Scope This part of IS0 6871 specifies requirements and test methods for nickel-based dental casting alloys suit- able for use in fabrication
38、 of removable dental ap- pliances. It does not apply to alloys intended for use in fabrication of metal-ceramic dental restorations. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 6871. At the time of
39、 publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 6871 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain regist
40、ers of currently valid International Standards. IS0 3696:1987, Water for analytical laboratory use - Specification and test methods. IS0 6892:1984, Metallic materials - Tensile testing. ASTM-B 600-74, Recommended practice for descal- ing and cleaning titanium and titanium alloy surfaces. 3 Definitio
41、ns For the purposes of this part of IS0 6871, the follow- ing definitions apply. 3.1 alloy: Metallic substance consisting of a mixture of the basic metallic element (the element predomi- nating by mass) and other elements such as alloying elements and impurities. 3.2 alloying element: Metallic or no
42、n-metallic el- ements added to or retained by a basic metal for the purpose of giving that metal certain special properties. 3.3 impurity: Metallic or non-metallic elements present but which are not intentionally added to or retained by a metal. 3.4 casting alloy: Alloy primarily intended for the pr
43、oduction of castings. 3.5 base metal casting alloy: Casting alloy in which cobalt or nickel is the basic metallic element. 3.6 nickel-based dental casting alloy: Dental cast- ing alloy in which nickel is the constituent present in the highest percentage by mass (main constituent). 4 Requirements 4.1
44、 Composition The chemical composition of the casting alloy shall meet the following requirements: Nickel main constituent Ch rom um Molybdenum not less than 20 % (dm) not less than 4 Yo ( d m ) Nickel + Cobalt + Chromium not less than 85 % (dm) If the alloy contains beryllium, the beryllium content
45、shall not exceed 2 % (dm). 1 IS0 b87L PT*2 94 W 4851903 057bb73 258 IS0 6871-2:1994(E) Constituents of the alloy in excess of 20 % (dm) shall be within 2 YO (dm) of the value stated see clause 8b) and 9.2d)l. Constituents in excess of 2 % (dm) but not in excess of 20 % (dm) shall be within 1 % (dm)
46、of the value stated see clause 8 b) and 9.2d)l. Other compositions with nickel as the basic metallic element may be permissible subject to approval by regulatory authorities (see the Introduction). For such alloys, all alloying elements with more than 0,l % (dm) shall be given on the package or in t
47、he accompanying literature. Q IS0 Table 1 - Mechanical moperties Percentage elongation after fracture Proof stress of non-proportional elongation, R, M Pa min. I YO min. I 500 I 3,O 5 Sampling The sample shall be adequate to prepare the speci- mens required for 6.2 and A.l, and shall be from one bat
48、ch. 4.2 Biocompatibility See the Introduction for guidance on biocompatibility. 4.3 Corrosion resistance See the Introduction for guidance on corrosion resist- ance. Testing shall be in accordance with annex A. The total of the mean aggregate quantity of ions released shall be reported as specified in A.3. 4.4 Mechanical properties When tested in accordance with 7.3 and 7.4, the mechanical properties of the alloy shall comply with table 1. Further sample and packaging shall be made available f