Abstract

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.