<p>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</p>
<p>a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,</p>
<p>b) in contact with teeth and/or dental implants,</p>
<p>c) for prevention of epithelial migration in periodontal surgery,</p>
<p>d) for the augmentation of bone prior to the planned insertion of dental implants,</p>
<p>e) and/or for augmentation of bone for stabilization of dental prostheses.</p>
<p>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.</p>
Registration number (WIID)
35132
Scope
<p>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</p>
<p>a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,</p>
<p>b) in contact with teeth and/or dental implants,</p>
<p>c) for prevention of epithelial migration in periodontal surgery,</p>
<p>d) for the augmentation of bone prior to the planned insertion of dental implants,</p>
<p>e) and/or for augmentation of bone for stabilization of dental prostheses.</p>
<p>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.</p>
