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.
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.
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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