ISO INTERNATIONAL STANDARD 10334 First edition 1994-08-01 Implants for surgery -- Malleable wires for use as sutures and other surgical applications ImplantschirurgicauxFilsmalleablespoursuturesetautres applicationschirurgicales Referencenumber ISO10334:1994(E) IS010334:1994(E) 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 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 Electrotechnicai Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees sare 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. ISO/Tc 150, Implants for surgery, Subcommittee Sc 5, Osteosynthesis. ISO 1994 Allrights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case Postale 56·CH-1211Geneve 20·Switzerland Printed in Switzerland ii INTERNATIONALSTANDARDISO ISO10334:1994(E) Implants for surgery - Malleable wires for use as sutures and other surgical applications 1 Scope Members of IEC and ISO maintain registers of cur- rentlyvalid International Standards. This International Standard specifies the dimensions Iso5832-1:1987.Implants for surgery- Metallic andmechanicalpropertiesofmalleablewiresforuse materialsPart 1:Wroughtstainlesssteel. assuturesandotherformsoftissueandimplantfix ation in surgery, and gives test methods. The mech- IsO 5832-2:1993, Implants for surgery anical properties specified are tensile strength, Metallio elongation, and resistance to damage in bending and materialsPart 2: Unalloyed titanium. in torsion. ISO5832-5:1993,Implantsforsurgery Metallic Surface finish is not covered by this International materials Part 5:Wrought cobalt-chromium Standard. tungsten-nickel alloy NOTES Iso 5832-9:1992,Implants for surgery —Metallic materials - Part 9: Wrought high nitrogen stainless 1 For such surgical applications, it is essential that the wire steel. can be twisted or knotted without fracturing or developing cracks or crevices in its surface. Iso6018:1987,Orthopaedic implants— General re 2 Malleable wires may be used in close relationship to quirementsformarking,packagingand labelling. other implants. In these circumstances, it is important that ISO 6892:1984, Metallic materials -Tensile testing. stainless steel wire of compositions D and E (see ISO 5832-1) should only be used in relation to implants Iso7800:1984.Metallicmaterials-Wire-Simple madeof corresponding stainless steel,and wires made of high-nitrogen stainless steel should only be used inrelation torsiontest. to implants of high-nitrogen stainless steel. This will reduce the possibility of galvanic corrosion occurring between the Is07801:1984,Metallic materials-Wire-Reverse wires and implant. bend test. ASTM F 86-91,Standard Practice for Surface Prep aration and Marking of Metallic Surgical Implants. 2 Normative references 3Materials The following standards contain provisions which, through reference in this text, constitute provisions Malleable wire shall be made from wrought stainless of this International Standard. At the time of publi- steel of composition D or E complying with cation, the editions indicated were valid. All standards ISO 5832-1, from unalloyed titanium complying with are subject to revision, and parties t