標準號：DIN EN ISO 22803-2006
中文標準名稱：牙科學.口腔及頜面外科中受控制的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 (ISO 22803:2004); English version of DIN EN ISO 22803:2006
標準類型：C33
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C33
國際標準分類號：11.060.10
引用標準：EN 1041;ISO 1942;ISO 10993-1;ISO 10993-7;ISO 11134;ISO 11135;ISO 11137;ISO 11607;ISO 14155-1;ISO 14937;ISO 14971;ISO 15223
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, whetherresorbable, 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 medicinalproduct, autografts and allografts, or materials intended to act through pharmacological, immunological ormetabolic means.