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
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— for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality,
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— in contact with teeth and/or dental implants,
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— for prevention of epithelial migration in periodontal surgery,
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— for the augmentation of bone prior to the planned insertion of dental implants,
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— 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.