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

[中文适用范围]： 本国际标准规定了评估膜材料的化学、物理、机械、生物和临床方面和行为的技术文件的要求，无论是可吸收的、部分可吸收的还是不可吸收的，这些材料用于引导组织再生口腔颌面手术以纠正形态缺陷或异常， — 与牙齿和/或牙种植体接触， — 预防牙周手术中的上皮迁移， — 在计划插入牙种植体之前增加骨量， — 以及/或用于增强骨骼以稳定假牙。 本国际标准不适用于主要用途是输送药品、自体移植物和同种异体移植物的材料，或旨在通过药理学、免疫学或代谢手段发挥作用的材料。 [外文原描述]： 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 a) for guided tissue regeneration in oral and maxillofacial surgery to correct a morphological defect or abnormality, b) in contact with teeth and/or dental implants, c) for prevention of epithelial migration in periodontal surgery, d) for the augmentation of bone prior to the planned insertion of dental implants, e) 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.