BS ISO 5838-1-2013 Implants for surgery Metallic skeletal pins and wires General requirements《外科植入物 金属骨针和钢丝 通用要求》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS ISO 5838-1:2013Implants for surgery Metallicskeletal pins and wiresPart 1: General requirementsBS ISO 5838-1:2013 BRITISH STANDARDNational forewordThis British Standard is the

2、 UK implementation of ISO 5838-1:2013. The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/5, Surgical Implants - Osteosynthesis and spinaldevices.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not

3、 purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013 ISBN 978 0 580 74601 7 ICS 11.040.40 Compliance with a British Standard cannot confer immunity fromlegal obl

4、igations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 March 2013. Amendments issued since publicationDate T e x t a f f e c t e dBS ISO 5838-1:2013 ISO 2013Implants for surgery Metallic skeletal pins and wires Part 1: General requirement

5、sImplants chirurgicaux Fils et broches pour os Partie 1: Matriaux et proprits mcaniquesINTERNATIONAL STANDARDISO5838-1Third edition2013-03-01Reference numberISO 5838-1:2013(E)BS ISO 5838-1:2013ISO 5838-1:2013(E)ii ISO 2013 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2013All rights reserved.

6、Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at t

7、he address below or ISOs member body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 5838-1:2013ISO 5838-1:2013(E) ISO 2013 All rights reserved iiiCont

8、ents PageForeword iv1 Scope . 12 Normative references 13 Material 24 Mechanical properties 25 Method of manufacture . 26 Finish 27 Sterilization . 28 Packaging . 39 Information supplied by the manufacturer . 39.1 General . 39.2 Instructions for use . 39.3 Marking on implant. 3BS ISO 5838-1:2013ISO 5

9、838-1:2013(E)ForewordISO (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 interested in a subject f

10、or 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 Electrotechnical Commission (IEC) on

11、 all matters of electrotechnical 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

12、 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.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held res

13、ponsible for identifying any or all such patent rights.ISO 5838-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis and spinal devices.This third edition cancels and replaces the second edition (ISO 5838-1:1995), which has been technically revise

14、d to add to the requirements for finish (Clause 6), to add a reference to ISO 14630 and to introduce new requirements for sterilization (Clause 7), packaging (Clause 8) and information supplied by the manufacturer (Clause 9).ISO 5838 consists of the following parts, under the general title Implants

15、for surgery Metallic skeletal pins and wires: Part 1: General requirements Part 2: Steinmann skeletal pins - Dimensions Part 3: Kirschner skeletal wiresiv ISO 2013 All rights reservedBS ISO 5838-1:2013INTERNATIONAL STANDARD ISO 5838-1:2013(E)Implants for surgery Metallic skeletal pins and wires Part

16、 1: General requirements1 ScopeThis part of ISO 5838 specifies general requirements for metallic skeletal pins and wires for use in bone surgery, excluding wires for binding and twisting.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document a

17、nd are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 3651-2, Determination of resistance to intergranular corrosion of stainless steels Part 2: Ferr

18、itic,austenitic and ferritic-austenitic (duplex) stainless steels Corrosion test in media containing sulfuric acidISO 5832-1, Implants for surgery Metallic materials Part 1: Wrought stainless steelISO 5832-2, Implants for surgery Metallic materials Part 2: Unalloyed titaniumISO 5832-3, Implants for

19、surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloyISO 5832-5, Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloyISO 5832-6, Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloyISO 5832

20、-7, Implants for surgery Metallic materials Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloyISO 5832-8, Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloyISO 5832-9, Implants for surgery Metallic materials Part

21、 9: Wrought high nitrogen stainless steelISO 5832-11, Implants for surgery Metallic materials Part 11: Wrought titanium 6-aluminium 7-niobium alloyISO 5832-12, Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloyISO 5832-14, Implants for surgery Metallic material

22、s Part 14: Wrought titanium 15-molybdenum 5-zirconium 3-aluminium alloyISO 6892-1, Metallic materials Tensile testing Part 1: Method of test at room temperatureISO 14630:2012, Non-active surgical implants General requirements ISO 2013 All rights reserved 1BS ISO 5838-1:2013ISO 5838-1:2013(E)3 Materi

23、alSkeletal pins and wires shall be made of wrought materials in accordance with ISO 5832-1, ISO 5832-2, ISO 5832-3, ISO 5832-5, ISO 5832-6, ISO 5832-7, ISO 5832-8, ISO 5832-9, ISO 5832-11, ISO 5832-12 and ISO 5832-14.4 Mechanical propertiesThe mechanical properties shall be in accordance with the re

24、quirements given in Table 1. The test methods in ISO 6892-1 shall be used in determining compliance with the tensile requirements.Table 1 Mechanical propertiesType of materialDiameterUltimate tensile strengthElongationad min. min.mm MPa %Wrought stainless steel1 3730 7503 5Wrought titanium alloys 6

25、1 030 3Wrought cobalt-chromium base alloy 6 1 240 7aGauge length = 565, Sowhere Sois the original cross-sectional area in mm2or equal to 50 mm if possible. If this is not possible, for wires smaller in diameter than 2,5 mm, a gauge length of 100 mm or 200 mm, equal to the total length between the gr

26、ips, may be used (ISO 6892-1). However, in this case, the minimum value of elongation shall be agreed between the interested parties.bISO 5832-1 includes an extra-hard classification to accommodate the need for very high strength stainless steels for osteosynthesis devices.cIn specific clinical appl

27、ications, the cross-sectional dimensions of the pin or wire used should correspond to the strength of the material.5 Method of manufactureSkeletal pins and wires shall be manufactured by a cold drawing or a cold working process. Welds are not permissible. If local heating is needed for re-shaping po

28、ints made of stainless steel, this can only be permitted provided that the whole of the final product can be shown to satisfy the intergranular corrosion test according to ISO 3651-2.6 FinishThe external surface finish shall be free from burs, scratches and other defects visible to the naked eye. Th

29、e products shall be appropriately treated to provide surface passivation.Special attention should be paid to screw threads, if applicable.7 SterilizationThe requirements of ISO 14630:2012, Clause 9, shall apply.2 ISO 2013 All rights reservedBS ISO 5838-1:2013ISO 5838-1:2013(E)8 PackagingThe requirem

30、ents of ISO 14630:2012, Clause 10, shall apply.9 Information supplied by the manufacturer9.1 GeneralThe requirements of ISO 14630:2012, Clause 11, apply together with the following particular requirement.9.2 Instructions for useThe requirements of ISO 14630:2012, 11.3, apply, and shall include the f

31、ollowing details when relevant:a) the product name,b) characteristic sizes,c) material specification, andd) the appropriate drill bit dimensional characteristics.9.3 Marking on implantThe requirements of ISO 14630:2012, 11.5, apply, and shall include the following details when the dimensions permit:

32、 the manufacturers name or trademark, and the batch code.Additional markings could include length and diameter or cross-sectional size for skeletal pins. ISO 2013 All rights reserved 3BS ISO 5838-1:2013ISO 5838-1:2013(E) ISO 2013 All rights reservedICS 11.040.40Price based on 3 pagesThis page delibe

33、rately left blankBSI is the independent national body responsible for preparing British Standards and other standards-related publications, information and services. It presents the UK view on standards in Europe and at the international level. BSI is incorporated by Royal Charter. British Standards

34、 and other standardisation products are published by BSI Standards Limited.British Standards Institution (BSI)raising standards worldwideBSI389 Chiswick High Road London W4 4AL UKTel +44 (0)20 8996 9001Fax +44 (0)20 8996 Standards and PASs are periodically updated by amendment or revision. Users of

35、 British Standards and PASs 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 British Standards would inform the Secreta

36、ry of the technical committee responsible, the identity of which can be found on the inside frontcover. Similary for PASs, please notify BSI Customer Services.Tel: +44 (0)20 8996 9001 Fax: +44 (0)20 8996 7001BSI offers BSI Subscribing Members an individual updating service called PLUS which ensures

37、that subscribers automatically receive the latest editions of British Standards and PASs.Tel: +44 (0)20 8996 7669 Fax: +44 (0)20 8996 7001Email: Buying standardsYou may buy PDF and hard copy versions of standards directly using acredit card from the BSI Shop on the website addition all orders for B

38、SI, international and foreign standards publicationscan be addressed to BSI Customer Services.Tel: +44 (0)20 8996 9001 Fax: +44 (0)20 8996 7001Email: In response to orders for international standards, BSI will supply the British Standard implementation of the relevant international standard, unless

39、otherwise requested.Information on standardsBSI provides a wide range of information on national, Europeanand international standards through its Knowledge Centre.Tel: +44 (0)20 8996 7004 Fax: +44 (0)20 8996 7005Email: BSI Subscribing Members are kept up to date with standards developments and recei

40、ve substantial discounts on the purchase priceof standards. For details of these and other benefits contact Membership Administration. Tel: +44 (0)20 8996 7002 Fax: +44 (0)20 8996 7001 Email: Information regarding online access to British Standards and PASs via British Standards Online can be found

41、 at information about British Standards is available on the BSI website at www.bsi- the data, software and documentation set out in all British Standards and other BSI publications are the property of and copyrighted by BSI, or some person or entity that own copyright in the information used (such

42、as the international standardisation bodies) has formally licensed such information to BSI for commerical publication and use. Except as permitted under the Copyright, Designs and Patents Act 1988 no extract may be reproduced, stored in a retrieval system or transmitted in any form or by any means e

43、lectronic, 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. Details and advice can be obtained from the Copyright & Licensing Department.Tel: +44 (0)20 8996 7070Email: