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.