BS-7252-13-1997 ISO-13782-1996.pdf
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1、BRITISH STANDARD BS 7252-13: 1997 ISO 13782: 1996 Metallic materials for surgical implants Part 13: Specification for unalloyed tantalum for surgical implant applications ICS 11.040.40 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:45 GMT+00:00 2007, Unco
2、ntrolled Copy, (c) BSI BS 7252-13:1997 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 June 1997 BSI 09-1999 The following BSI references relate to the wor
3、k on this standard: Committee reference CH/18 Draft for comment 95/560470 DC ISBN 0 580 27631 7 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/18, Surgical implant materials, upon which the following bodies were repre
4、sented: Association of British Health-Care Industries British Industrial Ceramic Manufacturers Association British Iron and Steel Producers Association British Medical Association British Orthopaedic Association British Surgical Trades Association Department of Health National Physical Laboratory Ro
5、yal College of Surgeons of England Royal Veterinary College Scottish Office Surgical Dressings Manufacturers Association The following bodies were also represented in the drafting of the standard, through subcommittees and panels: British Dental Association British Investment Casting Trade Associati
6、on Confederation of British Forgers Institute of Sterile Services of England Amendments issued since publication Amd. No.DateComments Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:45 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-13:1997 BSI 09-1999i
7、 Contents Page Committees responsibleInside front cover National forewordii Forewordiii Text of ISO 13782-1 Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:45 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-13:1997 ii BSI 09-1999 National foreword This
8、British Standard has been prepared by Technical Committee CH/18. It is identical with ISO 13782:1996 Implants for surgery Metallic materials Unalloyed tantalum for surgical implant applications, published by the International Organization for Standardization (ISO). Cross-references The Technical Com
9、mittee has reviewed the provisions of ISO 6892 and ISO 643 to which reference is made in the text, and has decided that they are acceptable for use in conjunction with this standard. A related British Standard to ISO 643 is BS 4490. Product certification. Users of the British Standard are advised to
10、 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 quality system against the appropriate standard in the BS EN ISO 9000 series. Enquiries
11、as to the availability of third party certification will be forwarded by BSI to the Association of Certification bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. A British Standard does n
12、ot 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 obligations. Summary of pages This document comprises a front cover, an inside
13、front cover, pages i and ii, the ISO title page, pages ii to iv, pages 1 and 2 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 the inside front cover. Licensed Copy: London South Bank Uni
14、versity, London South Bank University, Fri Oct 05 02:16:45 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:45 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-13:1997 ii BSI 09-1999 Contents Page Forewordiii Int
15、roduction-1 1Scope1 2Normative references1 3Chemical composition1 4Microstructure1 5Mechanical properties1 6Test methods1 Table 1 Chemical composition1 Table 2 Mechanical properties2 Table 3 Test methods2 Descriptors: Medical equipment, surgical implants, metallurgical products, tantalum, specificat
16、ions, materials specifications, chemical composition, microstructure, mechanical properties, tests. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:45 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS 7252-13:1997 BSI 09-1999iii Foreword ISO (the International
17、 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 committees. Each member body interested in a subject for which a technical committee has been est
18、ablished 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 International Electrotechnical Commission (IEC) on all matters of electrotechnical standardiz
19、ation. 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 member bodies casting a vote. International Standard ISO 13782 was prepared by Technical Committ
20、ee ISO/TC 150, Implants for surgery, Subcommittee SC 1, Materials. Introduction No known surgical implant material has ever been shown to cause absolutely no adverse reactions in the human body. However, long-term clinical experience of the use of the material referred to in this International Stand
21、ard has shown that an acceptable level of biological response can be expected, when the material is used in appropriate applications. Licensed Copy: London South Bank University, London South Bank University, Fri Oct 05 02:16:45 GMT+00:00 2007, Uncontrolled Copy, (c) BSI iv blank Licensed Copy: Lond
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