ISO INTERNATIONAL STANDARD 22794 First edition 2007-07-15 Dentistry Implantable materials for bone filling and augmentation in oral and maxillofacial surgery Contents of a technical file Art dentaire Materiaux implantables pour le remplissage et I'augmentation osseuse en chirurgie orale et maxillofaciale -Contenu d'un dossiertechnique Reference number ISO 22794:2007(E) @ ISO 2007 py IHS under ted without license from IHS Not for Resale ISO22794:2007(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by IsO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below COPYRIGHTPROTECTEDDOCUMENT @ISO2007 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, IsO's member body in the country of the requester. ISO copyright office Case postale 56. CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland @ ISO 2007 - All rights reserved edwithoutlicense from IHS Not for Resale ISO 22794:2007(E) Contents Page Foreword. Introduction 1 Scope 2 Normative references 3 Terms and definitions 4 Implantablematerials.. 5 Technical file 5.1 Contents 5.2 Chemical composition. 5.3 Physical properties.... 5.4 Intended applications, precautions, warnings and instructions 5.5 Preclinical and clinical evaluation .... 5.6 5.7 Materials of animal origin .. 5.8 Sterilization.... 5.9 Packaging 5.10 Additionai information supplied by the manufacturer Bibliography. CopyrghtInternationalOrganizaionsandardizaoghtsreserved ii nse from IHS Not for Resale ISO 22794:2007(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 InternationalElectrotechnicalCommission(iEC)onallmattersofelectrotechnicalstandardization. International Standards are drafted in accordance with the rules given in the ISO/lEC Directives, Part 2 The main task of technical committees is to prepare International Standards. 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 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 responsible for identifying any or all such patent rights. ISO 22794 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 8, Dental implants. @ ISo 2007 - Allrights reserved ional Organization for Standardization ISO 22794:2007(E) Introduction Different materials used for the preservation of masticatory function, such as dental restorative materials sand evaluate the performance of these products. the procedures for evaluating and testing dental restorative materials and dental implants; it is necessary to develop a new standard for these materials. The aim of this International Standard is to define the content of a technical file that demonstrates safety and effectiveness of bone filling and augmentation materials used in oral and maxillofacial surgery. Not for Resale aadizao No reproductic neworkingmitedwithout licenefrmH Not for Resale