Resumen
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.
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Informaciones generales
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Estado: PublicadoFecha de publicación: 2004-09Etapa: Norma Internacional confirmada [90.93]
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Edición: 1Número de páginas: 7
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Comité Técnico :ISO/TC 106/SC 8ICS :11.060.15
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