BS EN ISO 22803:2005

Dentistry. Membrane materials for guided tissue regeneration in oral and maxillofacial surgery. Contents of a technical file. | Status: Current, Under review

1 Scope 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.