EN ISO 22803:2005

Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)

ISO 22803:2004 gives the requirements for a technical file on the evaluation of the chemical, physical, mechanical, biological and clinical aspects and behaviour of membrane materials, whether resorbable, partially resorbable or non-resorbable, which are used
a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,
b) in contact with teeth and/or dental implants,
c) for prevention of epithelial migration in periodontal surgery,
d) for the augmentation of bone prior to the planned insertion of dental implants,
e) and/or for augmentation of bone for stabilization of dental prostheses.
This International Standard is not applicable to materials whose primary intended use is to deliver a medicinal product, autografts and allografts, or materials intended to act through pharmacological, immunological or metabolic means.

Zahnheilkunde - Membranmaterialien für die gesteuerte Geweberegeneration bei oralen und maxillofazialen Eingriffen - Inhalt der Technischen Dokumentation (ISO 22803:2004)

Art dentaire - Membranes pour régénération de tissus en chirurgie buccale et maxillo-faciale - Contenu du dossier technique (ISO 22803:2004)

L'ISO 22803:2004 spécifie les exigences pour un dossier technique sur l'évaluation des aspects chimique, physique, mécanique, biologique et clinique des membranes, et leur comportement, qu'elles soient résorbables, partiellement résorbables ou non résorbables, utilisées
a) pour corriger un défaut morphologique ou une malformation par régénération de tissus en chirurgie buccale et maxillo-faciale;
b) au contact des dents et/ou des implants dentaires;
c) pour prévenir la migration épithéliale en chirurgie parodontale;
d) dans le but d'une augmentation osseuse avant la mise en place programmée des implants dentaires;
e) et/ou dans le but d'une augmentation osseuse pour la stabilisation des prothèses dentaires.
L'ISO 22803:2004 n'est pas applicable aux matériaux dont l'objectif principal est de libérer un médicament, aux autogreffes et allogreffes, ou à des matériaux destinés à agir par des moyens pharmacologiques, immunologiques ou métaboliques.

Zobozdravstvo – Membranski materiali za vodeno obnavljanje tkiva v ustni in maksilofacialni kirurgiji – Vsebina tehnične mape (ISO 22803:2004)

General Information

• Status: Published
• Publication Date: 01-Nov-2005
• Withdrawal Date: 30-May-2006
• ICS: 11.060.15 - Dental implants
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 23-Feb-2010
• Completion Date: 23-Feb-2010
• Ref Project: SIST EN ISO 22803:2006 - Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file (ISO 22803:2004)

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 22803:2006
01-februar-2006
=RER]GUDYVWYR±0HPEUDQVNLPDWHULDOL]DYRGHQRREQDYOMDQMHWNLYDYXVWQLLQ
PDNVLORIDFLDOQLNLUXUJLML±9VHELQDWHKQLþQHPDSH,62
Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial
surgery - Contents of a technical file (ISO 22803:2004)
Zahnheilkunde - Membranmaterialien für die gesteuerte Geweberegeneration bei oralen
und maxillofazialen Eingriffen - Inhalt der Technischen Dokumentation (ISO 22803:2004)
Art dentaire - Membranes pour régénération de tissus en chirurgie buccale et maxillo-
faciale - Contenu du dossier technique (ISO 22803:2004)
Ta slovenski standard je istoveten z: EN ISO 22803:2005
ICS:
11.060.15 Zobni implantati Dental implants
SIST EN ISO 22803:2006 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 22803:2006

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SIST EN ISO 22803:2006
EUROPEAN STANDARD
EN ISO 22803
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2005
ICS 11.060.15

English Version
Dentistry - Membrane materials for guided tissue regeneration in
oral and maxillofacial surgery - Contents of a technical file (ISO
22803:2004)
Art dentaire - Membranes pour régénération de tissus en Zahnheilkunde - Membranmaterialien für die gesteuerte
chirurgie buccale et maxillo-faciale - Contenu du dossier Geweberegeneration bei oralen und maxillofazialen
technique (ISO 22803:2004) Eingriffen - Inhalt der Technischen Dokumentation (ISO
22803:2004)
This European Standard was approved by CEN on 7 October 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22803:2005: E
worldwide for CEN national Members.

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SIST EN ISO 22803:2006
EN ISO 22803:2005 (E)






Foreword



The text of ISO 22803:2004 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
22803:2005 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 May 2006, and conflicting national standards
shall be withdrawn at the latest by May 2006.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.



Endorsement notice

The text of ISO 22803:2004 has been approved by CEN as EN ISO 22803:2005 without any
modifications.

2

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SIST EN ISO 22803:2006
INTERNATIONAL ISO
STANDARD 22803
First edition
2004-09-01
Dentistry — Membrane materials for
guided tissue regeneration in oral and
maxillofacial surgery — Contents of a
technical file
Art dentaire — Membranes pour régénération de tissus en chirurgie
buccale et maxillo-faciale — Contenu du dossier technique

Reference number
ISO 22803:2004(E)
©
ISO 2004

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SIST EN ISO 22803:2006
ISO 22803:2004(E)
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