SIST EN ISO 22794:2010
(Main)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)
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)
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.
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)
Diese Internationale Norm ist anwendbar für implantierbare Materialien, ob resorbierbar oder nicht resorbierbar, die als Dentalprodukte zum Auffüllen von Knochendefekten und zur Augmentation bei oralen und maxillofazialen Eingriffen verwendet werden. Produkte, die im hauptsächlich aus reinem ( 90 %) Hydroxilapatit bestehen, werden in dieser Norm nicht beschrieben.
Die Bewertung umfasst die physikalisch-chemischen, mechanischen, biologischen und klinischen Aspekte und das Verhalten der implantierbaren Dentalprodukte.
Diese Internationale Norm gilt nicht für Materialien wie Autotransplantate, allogene Transplantate und Mem-branen, sowie für Produkte, deren hauptsächlicher Anwendungszweck darin besteht, ein Arzneimittel abzugeben.
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)
L'ISO 22794:2007 s'applique aux matériaux implantables, qu'ils soient résorbables ou non, utilisés comme dispositifs dentaires de comblement et de reconstruction osseuse en chirurgie buccale et maxillofaciale. Les produits constitués d'hydroxyapatite quasiment pure (> 90 %) ne relèvent pas de la présente Norme internationale.
L'évaluation inclut les aspects physico-chimiques, mécaniques, biologiques et cliniques ainsi que le comportement de ces matériaux dentaires implantables.
Zobozdravstvo - Vsaditveni materiali za polnjenje in povečanje kosti v ustni in maksilofacialni kirurgiji - Vsebina tehnične mape (ISO 22794:2007, popravljena različica 2009-01-15)
Ta mednarodni standard velja za absorptivne ali neabsorptivne vsaditvene materiale, ki se uporabljajo kot zobozdravstveni pripomočki za polnjenje in povečanje kosti v ustni in maksilofacialni kirurgiji. Ta mednarodni standard ne zajema proizvodov, ki so skoraj iz čistega (>90 %) hidroksiapatita. Ovrednotenje vključuje fizikalno-kemijske, mehanske, biološke in klinične vidike in obnašanje teh vsaditvenih zobozdravstvenih materialov. Ta mednarodni standard ne zajema avtotransplantatov, alotransplantatov in membran ter proizvodov, ki so predvsem namenjeni dovajanju zdravila.
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Standards Content (Sample)
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
SIST EN ISO 22794:2010
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
EN ISO 22794:2009 (E) 2 Contents Page Foreword .3 SIST EN ISO 22794:2010
EN ISO 22794:2009 (E) 3 Foreword The text of ISO 22794:2007, corrected version 2009-01-15 has been prepared by Technical Committee ISO/TC 106 “Dentistry” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 22794:2009 by Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2010, and conflicting national standards shall be withdrawn at the latest by January 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 22794:2007. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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 the United Kingdom. Endorsement notice The text of ISO 22794:2007, corrected version 2009-01-15 has been approved by CEN as a EN ISO 22794:2009 without any modification.
SIST EN ISO 22794:2010
SIST 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
SIST EN ISO 22794:2010
ISO 22794:2007(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 downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat 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.
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SIST EN ISO 22794:2010
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
SIST EN ISO 22794:2010
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.
SIST EN ISO 22794:2010
SIST EN ISO 22794:2010
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 medical devices ISO 14971, Medical devices — Application of risk management to medical devices ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied ISO 17665-1 7), Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices EN 1041, Information supplied by the manufacturer of medical devices 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply. 3.1 biocompatibility a) capability of a material to fulfil its function with an appropriate response for a specific application from the receiving host; b) quality of being accepted in a specific living environment without adverse or unwanted side effects 3.2 biomaterial a) material intended to interface with the biological system to evaluate, treat, augment or replace tissue, organ or function of the organism; b) material specially prepared and/or presented to exhibit bioacceptability, biocompatibility or positive biocompatiblity NOTE The implantable materials referred to in this document are all biomaterials. 3.3 filling surgical placement of a biomaterial, resorbable or non-resorbable, into an intrabony cavity during oral
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