ISO INTERNATIONAL 5835 STANDARD First edition 1991-01-15 Implants for surgery --- Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread - Dimensions Implants chirurgicaux - Vis métalliques pour os a raccord d'entrainement hexagonal, a embase spherique et filetage asymetrique Dimensions Reference number ISO 5835:1991(E) Not for Resale ted without license from IHS ISO 5835:1991(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, govern- mental and non-governmental, in liaison with IsO, also take part in the work. isoO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are national Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard isO 5835 was prepared by Technical Committee ISO/TC 150, Implants for surgery. This edition cancels and replaces the first edition Iso 5835-1:1985. Clause 5 and the annexes are new. Annexes A, B and C of this International Standard are for information only. ISO1991 or by any means, electronic or mechanical, including photocopying and microfim, without permission in writing from the publisher. International Organization for Standardization Case Postale 56: CH-1211 Geneve 20 · Switzerland Printed in Switzerland pyrighntemationarganizairStandardizaton ense from IHS Not for Resale ISO 5835:1991(E) Introduction This International Standard lays down requirements for surgical bone screws as given in clause 1. it is necessary, however, to bear in mind that there may be a need for bone screws for particular applications, which are not covered by this Standard or by IsO 9268. Such speciai bone screws may differ in part from the standardized forms or may combine parts from these two product standards (see annex A). However, there are certain areas of the design of screws such as the drive connections, the shape of the under-surface of the head and the thread form that are critical from the point of view of surgical use. These and IsO 9269) or with surgical instruments or other devices such as hexagon keys (Iso 8319-1) or taps, drills and countersink cutters. No variation is permitted in these areas. ili tworking permitted without license from IHS Not for Resale