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1、BRITISH STANDARD BS 7252-7: 1994 ISO 5832-7: 1994 Metallic materials for surgical implants Part 7: Specification for cobalt-chromium-nickel-molybdenum- iron alloy Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:11:48 GMT+00:00 2007, Uncontrolled Copy, (c) BSI
2、 BS 7252-7:1994 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 15 August 1994 BSI 08-1999 First published April 1990 Second edition August 1994 The follow
3、ing BSI references relate to the work on this standard: Committee reference HCC/18 Draft for comment 92/58311 DC ISBN 0 580 23410 X Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technic
4、al Committee HCC/18, upon which the following bodies were represented: Association of British Health-care Industries British Forging Industry Association British Industrial Ceramic Manufacturers Association British Institute of Surgical Technologists British Investment Casting Trade Association Brit
5、ish Medical Association British Orthopaedic Association British Steel Industry British Surgical Trades Association Department of Health Department of Trade and Industry (Laboratory of the Government Chemist) Department of Trade and Industry (National Physical Laboratory) Royal College of Surgeons of
6、 England Royal Veterinary College Scottish Office Sterilised Suture Manufacturers Association Surgical Dressings Manufacturers Association The following bodies were also represented in the drafting of the standard, through subcommittees and panels: British Dental Association Institute of Sterile Ser
7、vices Management Amendments issued since publication Amd. No.DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:11:48 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-7:1994 BSI 08-1999i Contents Page Committees responsibleInside front cover Natio
8、nal forewordii Introduction1 1Scope1 2Normative references1 3Chemical composition1 4Microstructure1 5Mechanical properties1 6Test methods1 Table 1 Chemical composition1 Table 2 Inclusion content limits1 Table 3 Mechanical properties2 Table 4 Test methods2 List of referencesInside back cover Licensed
9、 Copy: London South Bank University, London South Bank University, Fri Oct 05 02:11:48 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-7:1994 ii BSI 08-1999 National foreword This Part of BS 7252 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical
10、with ISO 5832-7:1994 Implants for surgery Metallic materials Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy, published by the International Organization for Standardization (ISO), and supersedes BS 7252-7:1990, which is withdrawn. Requirements for metallic materials f
11、or surgical implants were first published in BS 3531-2:1980. As a result of the development of so many disparate Parts of BS 3531 and because of the anticipated need to implement a number of published and forthcoming ISO standards that would have increased the diversity of BS 3531 still further, it
12、was decided that BS 3531 should be restructured as five distinct standards which would enable the various aspects to be clearly differentiated. BS 3531 itself was limited to standards specific to implants for osteosynthesis and its title changed accordingly. Four new standards were published incorpo
13、rating Parts of BS 3531 as well as new ISO standards, as follows: BS 7251, Orthopaedic joint protheses. BS 7252, Metallic materials for surgical implants. BS 7253, Non-metallic materials for surgical implants. BS 7254, Orthopaedic implants. It should be noted that, even though not deliberately added
14、, there will always be unquantified traces of other elements present in all alloys. This revision of BS 7252-7 specifies a chemical composition which includes silicon, phosphorus and sulfur, gives a lower limit on nickel and a slightly higher limit on molybdenum and manganese. It also specifies the
15、mechanical properties of the material whose condition is described as spring temper. Cross-references The Technical Committee has reviewed the provisions of ISO 643, ISO 4967 and ISO 6892, to which normative reference is made in the text, and has decided that they are acceptable for use in conjuncti
16、on with this standard. Product certification. Users of this British Standard are advised to consider the desirability of third party certification of product conformity with this British Standard based on testing and continuing product surveillance which may be coupled with assessment of a suppliers
17、 quality systems against the appropriate Part of BS 5750. Enquiries as to the availability of third party certification schemes are forwarded by BSI to the Association of Certification Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropri
18、ate body from the list of Association members. A British Standard does not purport to include 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 obligat
19、ions. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, pages 1 and 2, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on th
20、e inside front cover. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:11:48 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-7:1994 BSI 08-19991 Introduction No known surgical implant material has ever been shown to be completely free of adverse reactions i
21、n the human body. However, long-term clinical experience of the use of the material referred to in this part of ISO 5832 has shown that an acceptable level of biological response can be expected, when the material is used in appropriate conditions. 1 Scope This part of ISO 5832 specifies the charact
22、eristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants. NOTE 1The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with tho
23、se specified in this part of ISO 5832. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 5832. At the time of publication, the editions indicated were valid. All standards are subject to revision, and pa
24、rties to agreements based on this part of ISO 5832 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 643:1983, Steels Micrographic determinatio
25、n of the ferritic or austenitic grain size. ISO 4967:1979, Steel Determination of content of non-metallic inclusions Micrographic method using standard diagrams. ISO 6892:1984, Metallic materials Tensile testing. 3 Chemical composition The heat analysis of the alloy when determined as specified in c
26、lause 6 shall comply with the chemical composition specified in Table 1. The analysis of samples taken from products manufactured from the alloy shall also comply with Table 1. Table 1 Chemical composition 4 Microstructure 4.1 Grain size The microscopic structure shall be uniform. The grain size, de
27、termined as specified in clause 6, shall be no coarser than grain size No. 5. 4.2 Inclusion content The non-metallic inclusion content of the alloy, determined as specified in clause 6, shall not exceed the limits given in Table 2. Table 2 Inclusion content limits 5 Mechanical properties The mechani
28、cal properties, determined as specified in clause 6, shall be in accordance with the requirements of Table 3. 6 Test methods The test methods to be used in determining compliance with the requirements of this part of ISO 5832 shall be those given in Table 4. ElementCompositional limits, % (m/m) Coba
29、lt Chromium Nickel Molybdenum Manganese Silicon Carbon Phosphorus Sulfur Beryllium Iron 39 to 42 18,5 to 21,5 14 to 18 6,5 to 8 1 to 2,5 1 max. 0,15 max. 0,015 max. 0,015 max. 0,001 max. Balance Type of inclusion Inclusion content thina A Sulfides B Aluminates C Silicates D Oxides, globular 1 3 1 3
30、a There shall be no thick inclusions. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:11:48 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-7:1994 2 BSI 08-1999 Table 3 Mechanical properties Table 4 Test methods Condition Tensile strength Proof stress of n
31、on-proportional elongation Percentage elongation min. MPa min. MPa min. % Annealed95045065 30 % cold-worked1 4501 3008 Spring tempera1 6501 4001 a for specific applications. Requirement Relevant clause or subclause Test method Chemical composition3Recognized analytical procedures (ISO methods where
32、these exist) Inclusion content4.2ISO 4967 Grain size4.1ISO 643 Mechanical properties Tensile strength Percentage elongation Proof stress of non-proportional elongation 5ISO 6892 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:11:48 GMT+00:00 2007, Uncontrolle
33、d Copy, (c) BSI BS 7252-7:1994 BSI 08-1999 List of references See national foreword. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:11:48 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-7: 1994 ISO 5832-7: 1994 BSI 389 Chiswick High Road London W4 4AL BSI
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