標準號：BS EN ISO 22803-2006
中文標準名稱：牙科學.口腔及頜面外科中受控制組織再生用薄膜材料.技術文檔的內容
英文標準名稱：Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
標準類型：C33
發布日期：2006/1/13 12:00:00
實施日期：2006/1/13 12:00:00
中國標準分類號：C33
國際標準分類號：11.060.15
適用范圍：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.