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)

ISO 22794:2007 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 (greater than 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.

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.

General Information

Status
Published
Publication Date
18-Aug-2009
Withdrawal Date
27-Feb-2010
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
19-Aug-2009
Due Date
06-Nov-2010
Completion Date
19-Aug-2009

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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
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