This International Standard 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 — for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality, — in contact with teeth and/or dental implants, — for prevention of epithelial migration in periodontal surgery, — for the augmentation of bone prior to the planned insertion of dental implants, — 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.
BS EN ISO 22803:2006 history
2006BS EN ISO 22803:2006 Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
2006BS EN ISO 22803:2005 Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file