标准编号:ISO 22794:2007
中文名称:牙科 口腔和上颌面外科手术中骨质填充与加固用可植入材料 技术文件的内容
英文名称:Dentistry — Implantable materials for bone filling and augmentation in oral and maxillofacial surgery — Contents of a technical file
发布日期:2007-07
标准范围
This International Standard applies to implantable materials, whether resorbable or non-resorbable, used asdental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentiallypure (> 90 %) hydroxyapatite are not covered by this International Standard.Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of theseimplantable dental materials.Materials such as autografts, allografts and membranes, and products for which the primary intended use is todeliver a medicinal product, are not covered by this International Standard.