ISO 22803-2004 牙科学.口腔及颌面外科中受控制的组织再生用薄膜材料.技术文档的内容

标准号：ISO 22803-2004
中文标准名称：牙科学.口腔及颌面外科中受控制的组织再生用薄膜材料.技术文档的内容
英文标准名称：Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
标准类型：C33
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C33
国际标准分类号：11.060.10
适用范围：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.