EN ISO 22794:2007

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Will be a CR ++ VA/ISO removed (CC/010808) ++ Might be re-registered under VA/ISO but problem with the deliverable! (NT/030206). ++ Wrongly registered as a CR --> deliverable changed further to info from CEN/TC Sec and registered under VA/ISO with ISO/AWI 22794 (NT/030213).

Zahnheilkunde - Implantierbare Materialien zum Auffüllen von Knochendefekten und zur Augmentation bei oralen und maxillofazialen Eingriffen - Inhalt der Technischen Dokumentation (ISO 22794:2007)

Diese Internationale Norm gilt 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 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 vorrangiger Verwendungszweck darin besteht, ein Arzneimittel abzugeben.

Art dentaire - Matériaux implantables pour le remplissage et l'augmentation osseuse en chirurgie orale et maxillofaciale - Contenu d'un dossier technique (ISO 22794:2007)

Zobozdravstvo – Vsaditveni materiali za polnjenje in povečanje kosti v ustni in maksilofacialni kirurgiji – Vsebina tehnične mape (ISO 22794:2007)

General Information

• Status: Withdrawn
• Publication Date: 14-Jul-2007
• Withdrawal Date: 18-Aug-2009
• ICS: 11.060.15 - Dental implants
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 19-Aug-2009
• Completion Date: 19-Aug-2009
• Ref Project: SIST EN ISO 22794:2007 - Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007)

Relations

• Replaced By: EN ISO 22794:2009 - 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)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 22794:2007
01-september-2007
=RER]GUDYVWYR±9VDGLWYHQLPDWHULDOL]DSROQMHQMHLQSRYHþDQMHNRVWLYXVWQLLQ
PDNVLORIDFLDOQLNLUXUJLML±9VHELQDWHKQLþQHPDSH,62
Dentistry - Implantable materials for bone filling and augmentation in oral and
maxillofacial surgery - Contents of a technical file (ISO 22794:2007)
Zahnheilkunde - Implantierbare Materialien zur Auffüllung von Knochendefekten und zur
Augmentation bei oralen und maxillofazialen Eingriffen - Inhalt der Technischen
Dokumentation (ISO 22794:2007)
Art dentaire - Matériaux implantables pour le remplissage et l'augmentation osseuse
dans la chirurgie orale et maxillofaciale - Contenu d'un dossier technique (ISO
22794:2007)
Ta slovenski standard je istoveten z: EN ISO 22794:2007
ICS:
11.060.15 Zobni implantati Dental implants
SIST EN ISO 22794:2007 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 22794
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.060.15

English Version
Dentistry - Implantable materials for bone filling and
augmentation in oral and maxillofacial surgery - Contents of a
technical file (ISO 22794:2007)
Art dentaire - Matériaux implantables pour le remplissage et Zahnheilkunde - Implantierbare Materialien zum Auffüllung
l'augmentation osseuse en chirurgie orale et maxillofaciale von Knochendefekten und zur Augmentation bei oralen und
- Contenu d'un dossier technique (ISO 22794:2007) maxillofazialen Eingriffen - Inhalt der Technischen
Dokumentation (ISO 22794:2007)
This European Standard was approved by CEN on 20 June 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22794:2007: E
worldwide for CEN national Members.

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EN ISO 22794:2007 (E)





Foreword


This document (EN ISO 22794:2007) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with 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 2008, and conflicting national
standards shall be withdrawn at the latest by January 2008.

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 United
Kingdom.


Endorsement notice

The text of ISO 22794:2007 has been approved by CEN as EN ISO 22794:2007 without any
modifications.

2

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INTERNATIONAL ISO
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 — Matériaux implantables pour le remplissage et
l'augmentation osseuse en chirurgie orale et maxillofaciale — Contenu
d'un dossier technique




Reference number
ISO 22794:2007(E)
©
ISO 2007

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ISO 22794:2007(E)
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