BS 7507-1995 Specification for malleable wires for use as sutures and other surgical applications《用作缝线和其它外科用的可锻金属线规范》.pdf

1、BRITISH STANDARD BS 7507:1995 ISO 10334: 1994 Specification for Malleable wires for use as sutures and other surgical applicationsBS7507:1995 This British Standard, having been prepared under the directionof the Health andEnvironment Sector Board,waspublished undertheauthorityof theStandardsBoardand

2、 comesinto effecton 15 February 1995 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment 92/52888 DC ISBN 0 580 23845 8 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Te

3、chnical Committee HCC/22, Implants for osteosynthesis, upon which the following bodies were represented: Association of British Health-care Industries British Investment Casting Trade Association British Medical Association British Steel Industry British Surgical Trades Association Department of Hea

4、lth Institute of Sterile Services Management Medical Sterile Products Association National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS7507:1995 BSI 10-1999 i Contents Page Com

5、mittees responsible Inside front cover National foreword ii 1 Scope 1 2 Normative references 1 3 Materials 1 4 Surface preparation 1 5 Dimensions 1 6 Mechanical properties 1 7 Packaging and marking 3 8 Test methods 3 Table 1 Dimensions and mechanical properties of wires made of stainless steel compl

6、ying with ISO5832-1 2 Table 2 Dimensions and mechanical properties of wires made of unalloyed titanium complying with ISO5832-2 2 Table 3 Dimensions and mechanical properties of wire made of cobalt-based alloy complying with ISO5832-5 2 Table 4 Dimensions and mechanical properties of wires made of h

7、igh-nitrogen stainless steel complying with ISO5832-9 3 Table 5 Conditions for tests for resistance to bending and torsion 3 Table 6 Test methods 3 List of references Inside back coverBS7507:1995 ii BSI 10-1999 National foreword This British Standard has been prepared under the direction of the Heal

8、th and Environment Sector Board. It is identical with ISO10334:1994 Implants for surgery Malleable wires for use as sutures and other surgical applications, published by the International Organization for Standardization (ISO). This standard supersedes BS4106:1967, which is withdrawn. The Technical

9、Committee has reviewed the provisions of ISO6892:1984, ISO7800:1984, ISO7801:1984 and ASTM F86-91 1) , to which reference is made in the text, and has decided that they are acceptable for use in connection with this standard. A related British Standard to ISO7800:1984 is BS4545:1970. Product certifi

10、cation. 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 quality systems against the appropr

11、iate 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 third party certification scheme does not already exist, users should consider approaching an appropriate body from the lis

12、t 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 obligations. Summary of page

13、s This document comprises a front cover, an inside front cover, pagesi andii, pages1to4, 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 the inside front cover. Cross

14、-references International Standard Corresponding British Standard BS 7252 Metallic materials for surgical implants ISO 5832-1:1987 Part 1:1990 Specification for wrought stainless steel (Identical) ISO 5832-2:1993 Part 2:1994 Specification for unalloyed titanium (Identical) ISO 5832-5:1993 Part 5:199

15、4 Specification for wrought cobalt-chromium-tungsten-nickel alloy (Identical) ISO 5832-9:1992 Part 9:1993 Specification for high-nitrogen stainless steel (Identical) ISO 6018:1987 BS 7254 Orthopaedic implants Part 1:1990 Specification for marking, packaging and labelling (Identical) 1) Available fro

16、m Customer Services, BSI, 389 Chiswick High Road, London W44AL.BS7507:1995 BSI 10-1999 1 1 Scope This International Standard specifies the dimensions and mechanical properties of malleable wires for use as sutures and other forms of tissue and implant fixation in surgery, and gives test methods. The

17、 mechanical properties specified are tensile strength, elongation, and resistance to damage in bending and in torsion. Surface finish is not covered by this International Standard. NOTE 1For such surgical applications, it is essential that the wire can be twisted or knotted without fracturing or dev

18、eloping cracks or crevices in its surface. NOTE 2Malleable wires may be used in close relationship to other implants. In these circumstances, it is important that stainless steel wire of compositions D and E (see ISO5832-1) should only be used in relation to implants made of corresponding stainless

19、steel, and wires made of high-nitrogen stainless steel should only be used in relation to implants of high-nitrogen stainless steel. This will reduce the possibility of galvanic corrosion occurring between the wires and implant. 2 Normative references The following standards contain provisions which

20、, through reference in this text, constitute provisions 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 o

21、f applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 5832-1:1987, Implants for surgery Metallic materials Part 1: Wrought stainless steel. ISO 5832-2:1993, Implants for surgery Metallic materia

22、ls Part 2: Unalloyed titanium. ISO 5832-5:1993, Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy. ISO 5832-9:1992, Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel. ISO 6018:1987, Orthopaedic implants General requireme

23、nts for marking, packaging and labelling. ISO 6892:1984, Metallic materials Tensile testing. ISO 7800:1984, Metallic materials Wire Simple torsion test. ISO 7801:1984, Metallic materials Wire Reverse bend test. ASTM F 86-91, Standard Practice for Surface Preparation and Marking of Metallic Surgical

24、Implants. 3 Materials Malleable wire shall be made from wrought stainless steel of composition D or E complying with ISO5832-1, from unalloyed titanium complying with ISO5832-2, from wrought high-nitrogen stainless steel complying with ISO5832-9, or from wrought cobalt-chromium-tungsten-nickel alloy

25、 complying with ISO5832-5. 4 Surface preparation The wire may be subjected to a passivation process if requested by the customer. Such passivation process shall be performed in accordance with ASTM F86. 5 Dimensions The nominal diameter of the wire shall be stated by the manufacturer (seeclause8). T

26、he actual diameter of the wire shall equal the nominal diameter within the relevant tolerances given inTable 1, Table 2,Table 3orTable 4. 6 Mechanical properties 6.1 Tensile test The tensile properties of the wire, determined as specified in clause8, shall be in accordance withTable 1,Table 2,Table

27、3orTable 4. 6.2 Reverse bend test Where applicable, the wire shall be tested as specified in ISO7801, and in accordance with the bending angles and number of cycles laid down inTable 5. The wire shall not fracture and no cracks shall be visible on the surface. 6.3 Torsion test Where applicable, the

28、wire shall be tested as specified in ISO7800, and in accordance with the number of cycles laid down inTable 5. The wire shall not fracture. No cracks should be visible on the surface.BS7507:1995 2 BSI 10-1999 Table 1 Dimensions and mechanical properties of wires made of stainless steel complying wit

29、h ISO5832-1 Table 2 Dimensions and mechanical properties of wires made of unalloyed titanium complying with ISO5832-2 Table 3 Dimensions and mechanical properties of wire made of cobalt-based alloy complying with ISO5832-5 Wire diameter Maximum tensile strength Minimum elongation mm nom. tol. MPa %

30、0,1 to 0,199 0,2 to 0,299 0,3 to 0,599 0,6 to 0,799 0,8 to 1,099 1,1 to 1,6 0,005 0,007 5 0,01 0,013 0,02 0,025 895 860 825 790 760 690 30 30 30 35 35 40 Grade Wire diameter Maximum tensile strength Minimum elongation mm nom. tol. MPa % 1 0,125 to 0,249 0,25 to 0,749 0,75 to 1,6 0,013 0,025 0,05 400

31、 10 10 12 2 0,125 to 0,249 0,25 to 0,749 0,75 to 1,6 0,013 0,025 0,05 490 8 8 10 3 0,125 to 0,249 0,25 to 0,749 0,75 to 1,6 0,013 0,025 0,05 580 6 6 8 4 0,125 to 0,249 0,25 to 0,749 0,75 to 1,6 0,013 0,025 0,05 680 4 4 6 Wire diameter Maximum tensile strength Minimum elongation mm nom. tol. MPa % 0,

32、1 to 0,199 0,2 to 0,299 0,3 to 0,599 0,6 to 0,799 0,8 to 1,099 1,1 to 1,6 0,005 0,007 5 0,01 0,013 0,02 0,025 1 450 1 380 1 310 1 240 1 170 1 140 35 40 40 45 45 45BS7507:1995 BSI 10-1999 3 Table 4 Dimensions and mechanical properties of wires made of high-nitrogen stainless steel complying with ISO5

33、832-9 Table 5 Conditions for tests for resistance to bending and torsion Table 6 Test methods 7 Packaging and marking Malleable wire shall be packaged and marked as specified in ISO6018. The material and nominal diameter of the wire shall be stated. The packaging shall protect the wire from damage a

34、nd contamination. If the wire is packaged in a coiled configuration, the wire should lie flat and not adopt substantial corkscrew set. 8 Test methods The test methods to be used in determining compliance with the requirements of this specification shall be those given inTable 6. Representative test

35、pieces for the determination of mechanical properties shall be prepared in accordance with the provisions of ISO6892. Wire diameter Maximum tensile strength Minimum elongation mm nom. tol. MPa % 0,1 to 0,199 0,2 to 0,299 0,3 to 0,599 0,6 to 0,799 0,8 to 1,099 1,1 to 1,6 0,005 0,007 5 0,01 0,013 0,02

36、 0,025 1 370 1 300 1 230 1 160 1 100 1 070 15 20 20 25 25 25 Wire diameter Angular deflection from zero position aNumber of bending cycles Number of torsion cycles nom. mm 0,15 to 0,299 0,3 to 0,799 0,8 to 1,099 1,1 to 1,6 40 40 30 30 20 15 12 4 10 7,5 6 2 a Applies to reverse bending test only. Req

37、uirements Relevant subclause Test methods Mchanical properties Ultaminate tensile strength 6.1 ISO 6892 Elongation ISO 6892 Reverse bend test 6.2 ISO 7801 Torsion test 6.3 ISO 78004 blankBS7507:1995 BSI 10-1999 List of references See national foreword.BS 7507:1995 ISO 10334: 1994 BSI 389 Chiswick Hi

38、gh Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent 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 amendmen

39、t or revision. Users of BritishStandards should make sure that they possess 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 i

40、nform the Secretary of the technical committee responsible, the identity of 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 standa

41、rds. Buying standards Orders for all BSI, international and foreign standards 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 publishe

42、d as BritishStandards, unless otherwise requested. Information on standards 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

43、 give details on all its products and services. Contact the Information Centre. 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 c

44、ontact Membership Administration. Tel:02089967002. Fax:02089967001. Copyright Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of the publications of the international standardization bodies. Except as permitted under the Copyright, Designs and Patents Act 1988 no

45、 extract may be reproduced, stored in a retrieval system or transmitted in 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 a

46、s 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.