NF EN ISO 22803

January 2006

Standard Current

Dentistry — Membrane materials for guided tissue regeneration in oral and maxillofacial surgery — Contents of a technical file

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Main informations

Collections

National standards and national normative documents

Publication date

January 2006

Number of pages

16 p.

Reference

NF EN ISO 22803

ICS Codes

11.060.15 Dental implants

Print number

1 - 09/01/2006

International kinship

ISO 22803:2004

European kinship

EN ISO 22803:2005

Replaced standards (1)

NF ISO 22803

February 2005

Standard Cancelled

Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file

Le présent document définit le contenu du dossier technique qui démontre la sécurité et l'efficacité des membranes utilisées en chirurgie buccale et maxillo-faciale. Il spécifie les exigences du 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 : - pour corriger un défaut morphologique ou une malformation par régénération de tissus en chirurgie buccale et maxillo-faciale ; - au contact des dents et/ou des implants dentaires ; - pour prévenir la migration épithéliale en chirurgie parodontale ; - dans le but d'une augmentation osseuse avant la mise en place programmée des implants dentaires ; - et/ou dans le but d'une augmentation osseuse pour la stabilisation des prothèses dentaires. Il 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.

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