BS 7252-13-1997 Metallic materials for surgical implants - Specification for unalloyed tantalum for surgical implant applications《外科植入物用金属材料 外科植入用非合金钽规范》.pdf

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 11.040.40BS7252-13:1997 This British Standard, having been prepared under the directionof the Health and Environment Sector B

2、oard, waspublished under the authorityof the Standards Boardand comes into effect on 15 June1997 BSI 09-1999 The following BSI references relate to the work on this standard: Committee reference CH/18 Draft for comment 95/560470 DC ISBN 0 580 27631 7 Committees responsible for this British Standard

3、The preparation of this British Standard was entrusted to Technical Committee CH/18, Surgical implant materials, upon which the following bodies were represented: Association of British Health-Care Industries British Industrial Ceramic Manufacturers Association British Iron and Steel Producers Assoc

4、iation British Medical Association British Orthopaedic Association British Surgical Trades Association Department of Health National Physical Laboratory Royal College of Surgeons of England Royal Veterinary College Scottish Office Surgical Dressings Manufacturers Association The following bodies wer

5、e also represented in the drafting of the standard, through subcommittees and panels: British Dental Association British Investment Casting Trade Association Confederation of British Forgers Institute of Sterile Services of England Amendments issued since publication Amd. No. Date CommentsBS7252-13:

6、1997 BSI 09-1999 i Contents Page Committees responsible Inside front cover National foreword ii Foreword iii Text of ISO 13782 -1BS7252-13:1997 ii BSI 09-1999 National foreword This British Standard has been prepared by Technical Committee CH/18. It is identical with ISO 13782:1996 Implants for surg

7、ery Metallic materials Unalloyed tantalum for surgical implant applications, published by the International Organization for Standardization (ISO). Cross-references The Technical Committee has reviewed the provisions of ISO6892 and ISO643 to which reference is made in the text, and has decided that

8、they are acceptable for use in conjunction with this standard. A related British Standard to ISO643 is BS4490. Product certification. Users of the British Standard are advised to consider the desirability of third party certification of product conformity with this British Standard, based on testing

9、 and continuing product surveillance, which may be coupled with assessment of a suppliers quality system against the appropriate standard in the BSENISO9000 series. Enquiries as to the availability of third party certification will be forwarded by BSI to the Association of Certification bodies. If a

10、 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 not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correc

11、t 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 front cover, pagesi andii, theISO title page, pagesiitoiv, pages 1 and 2 and a back cover. This standard has been updated (se

12、e copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.BS7252-13:1997 ii BSI 09-1999 Contents Page Foreword iii Introduction -1 1 Scope 1 2 Normative references 1 3 Chemical composition 1 4 Microstructure 1 5 Mechanical pro

13、perties 1 6 Test methods 1 Table 1 Chemical composition 1 Table 2 Mechanical properties 2 Table 3 Test methods 2 Descriptors: Medical equipment, surgical implants, metallurgical products, tantalum, specifications, materials specifications, chemical composition, microstructure, mechanical properties,

14、 tests.BS7252-13:1997 BSI 09-1999 iii 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 committees. Each member body

15、 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 International Electrotec

16、hnical 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 least75% of the member bodies casting a vote.

17、 International Standard ISO13782 was prepared by Technical Committee ISO/TC150, Implants for surgery, Subcommittee SC1, 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

18、 the use of the material referred to in this International Standard has shown that an acceptable level of biological response can be expected, when the material is used in appropriate applications.iv blankBS7252-13:1997 BSI 09-1999 1 1 Scope This International Standard specifies the characteristics

19、of, and corresponding test methods for, unalloyed tantalum sheet, rod and wire used in the manufacture of surgical implants. NOTE 1Provision is made for two grades of tantalum. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisi

20、ons of this International Standard. At the time of publication, the editions indicated 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 recent editions of the standards

21、 indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 6892:1984, Metallic materials Tensile testing. ISO 643:1983, Steels Micrographic determination of the ferritic or austenitic grain size. 3 Chemical composition The heat analysis of a represent

22、ative sample of the material when determined in accordance with clause6 shall comply with the chemical composition specified in Table 1. Ingot analysis shall be used for reporting all chemical requirements. The analysis of hydrogen shall be carried out after the final heat treatment and the final su

23、rface treatment. Requirements for the major and minor elemental constituents for unalloyed tantalum are listed in Table 1. Table 1 Chemical composition 4 Microstructure The microscopic structure of the tantalum shall be uniform, and the grain size, determined in accordance with clause 6, shall not b

24、e coarser than grain size No. 5. 5 Mechanical properties The mechanical properties of the material, when tested in accordance with clause 6, shall comply with the values specified in Table 2. 6 Test methods The test methods to be used in determining compliance with this International Standard shall

25、be those given in Table 3. Representative test pieces for the determination of the tensile properties shall be prepared in accordance with ISO6892. Element Composition limits, % (m/m) RO5200 a RO5400 b Carbon Oxygen Nitrogen Hydrogen Niobium Iron Titanium Tungsten Molybdenum Silicon Nickel Tantalum

26、0,010 0,015 0 0,010 0,001 5 0,100 0,010 0,010 0,05 0,020 0,005 0 0,010 balance 0,010 0,030 0,010 0,001 5 0,100 0,010 0,010 0,05 0,020 0,005 0 0,010 balance a Electron beam or vacuum-arc cast tantalum. b Sintered tantalum.BS7252-13:1997 2 BSI 09-1999 Table 2 Mechanical properties Table 3 Test methods

27、 Form Condition Thickness or diameter Tensile strength Proof stress of nonproportional elongation Percentage elongation after fracture d R m min. R p0,2 min. A min. mm MPa MPa Sheet and strip Annealed 0,13 u d u 0,26 210 140 20 0,26 0,51 30 Stress-relieved after cold work 0,13 u d u 0,26 380 240 5 0

28、,26 10 Cold-worked 0,13 u d u 0,26 520 345 0,26 2 Rod and wire Annealed 0,25 u d u 0,38 240 10 0,38 d u 0,63 240 15 0,63 d u 3,14 210 20 3,14 d u 63,5 170 140 25 Cold-worked all 480 345 1 Parameter Relevant clause Test method Chemical composition 3 Recognized analytical procedures (ISO methods where

29、 these exist) Grain size 4 ISO 643 Mechanical properties 5 Tensile strength ISO 6892 Proof stress of nonproportional elongation ISO 6892 Percentage elongation ISO 68923 blankBS 7252-13: 1997 ISO 13782: 1996 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the independen

30、t national body responsible for preparing BritishStandards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions BritishStandards are updated by amendment or revision. Users of BritishStandards should make sure that they posses

31、s the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this BritishStandard would inform the Secretary of the technical committee responsible, the identity o

32、f which can be found on the inside front cover. Tel:02089969000. Fax:02089967400. BSI offers members an individual updating service called PLUS which ensures that subscribers automatically receive the latest editions of standards. Buying standards Orders for all BSI, international and foreign standa

33、rds publications should be addressed to Customer Services. Tel:02089969001. Fax:02089967001. In response to orders for international standards, it is BSI policy to supply the BSI implementation of those that have been published as BritishStandards, unless otherwise requested. Information on standard

34、s BSI provides a wide range of information on national, European and international standards through its Library and its Technical Help to Exporters Service. Various BSI electronic information services are also available which give details on all its products and services. Contact the Information Ce

35、ntre. Tel:02089967111. Fax:02089967048. Subscribing members of BSI are kept up to date with standards developments and receive substantial discounts on the purchase price of standards. For details of these and other benefits contact Membership Administration. Tel:02089967002. Fax:02089967001. Copyri

36、ght Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of the publications of the internationalstandardization bodies. Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in

37、any form or by any means electronic, photocopying, recording or otherwise without prior written permission from BSI. This does not preclude the free use, in the course of implementing the standard, of necessary details such as symbols, and size, type or grade designations. If these details are to be used for any other purpose than implementation then the prior written permission of BSI must be obtained. If permission is granted, the terms may include royalty payments or a licensing agreement. Details and advice can be obtained from the Copyright Manager. Tel:02089967070.