EN ISO 22794:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Zahnheilkunde - Implantierbare Materialien zum Auffüllen von Knochendefekten und zur Augmentation bei oralen und maxillofazialen Eingriffen - Inhalt der Technischen Dokumentation (ISO 22794:2007, korrigierte Fasung 2009-01-15)Art dentaire - Matériaux implantables de comblement et de reconstruction osseuse en chirurgie orale et maxillofaciale - Contenu d'un dossier technique (ISO 22794:2007, version corrigée 2009-01-15)Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15)11.060.15Zobni implantatiDental implantsICS:Ta slovenski standard je istoveten z:EN ISO 22794:2009SIST EN ISO 22794:2010en01-januar-2010SIST EN ISO 22794:2010SLOVENSKI
STANDARDSIST EN ISO 22794:20071DGRPHãþD

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 22794August 2009ICS 11.060.15Supersedes EN ISO 22794:2007
English VersionDentistry - Implantable materials for bone filling andaugmentation in oral and maxillofacial surgery - Contents of atechnical file (ISO 22794:2007, corrected version 2009-01-15)Art dentaire - Matériaux implantables de comblement et dereconstruction osseuse en chirurgie orale et maxillofaciale -Contenu d'un dossier technique (ISO 22794:2007, versioncorrigée 2009-01-15)Zahnheilkunde - Implantierbare Materialien zum Auffüllenvon Knochendefekten und zur Augmentation bei oralen undmaxillofazialen Eingriffen - Inhalt der TechnischenDokumentation (ISO 22794:2007, korrigierte Fasung 2009-01-15)This European Standard was approved by CEN on 3 August 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 22794:2009: ESIST EN ISO 22794:2010

Reference numberISO 22794:2007(E)© ISO 2007
INTERNATIONAL STANDARD ISO22794First edition2007-07-15Corrected version2009-01-15Dentistry — Implantable materials for bone filling and augmentation in oral and maxillofacial surgery — Contents of a technical file Art dentaire — Matériaux implantables de comblement et de reconstruction osseuse en chirurgie orale et maxillofaciale — Contenu d'un dossier technique
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ii © ISO 2007 – All rights reserved
ISO 22794:2007(E) © ISO 2007 – All rights reserved iiiContents Page Foreword.iv Introduction.v 1 Scope.1 2 Normative references.1 3 Terms and definitions.2 4 Implantable materials.3 5 Technical file.3 5.1 Contents.3 5.2 Chemical composition.3 5.3 Physical properties.4 5.4 Intended applications, precautions, warnings and instructions.4 5.5 Preclinical and clinical evaluation.5 5.6 Manufacture.6 5.7 Materials of animal origin.6 5.8 Sterilization.6 5.9 Packaging.7 5.10 Additional information supplied by the manufacturer.7 Bibliography.9
ISO 22794:2007(E) iv © ISO 2007 – All rights reserved 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 Electrotechnical Commission (IEC) on 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 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. In this corrected version of ISO 22794:2007 changes have been made to the list of Normative references (Clause 2) and to the Bibliography. Consequently cross-references in subclauses 5.2, 5.5.5, 5.7, 5.8 and 5.9.2 have been altered. Further, new subclauses 5.5.3 and 5.5.4 have been designated with the former 5.5.3 becoming 5.5.5. SIST EN ISO 22794:2010

ISO 22794:2007(E) © ISO 2007 – All rights reserved vIntroduction Different materials used for the preservation of masticatory function, such as dental restorative materials and dental implants are subject to standards and regulations, either in existence or in preparation, designed to evaluate the performance of these products. Implantable materials for bone filling and augmentation in oral and maxillofacial surgery are not covered by 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.
INTERNATIONAL STANDARD ISO 22794:2007(E) © ISO 2007 – All rights reserved 1Dentistry — Implantable materials for bone filling and augmentation in oral and maxillofacial surgery — Contents of a technical file 1 Scope This International Standard applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (> 90 %) hydroxyapatite are not covered by this International Standard. Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials. Materials such as autografts, allografts and membranes, and products for which the primary intended use is to deliver a medicinal product, are not covered by this International Standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942 1), Dentistry — Vocabulary ISO 10993-1 2), Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management system ISO 10993-17, Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances ISO 11135-1 3), Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-1 4), Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11607-2 5), Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
1) To be published. (Revises and replaces ISO 1942 parts 1 to 5:1989) 2) To be published. (Revision of ISO 10993-1:2003) 3) Cancels and replaces ISO 11135:1994 and ISO 11135:1994/Cor.1:1994. 4) Cancels and replaces ISO 11137:1995, ISO 11137:1995/Cor.1:1997 and ISO 11137:1995/Amd.1:2001. 5) Cancels and replaces ISO 11607:2003. SIST EN ISO 22794:2010

ISO 22794:2007(E) 2 © ISO 2007 – All rights reserved ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements ISO 14155-1 6), Clinical investigation of medical devices for human subjects — Part 1: General requirements ISO 14155-2 6), Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for med
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