ISO 22794:2007 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

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

ISO 22794:2007适用于可吸收或不可吸收的可植入材料，在口腔颌面外科中用作填充和增强骨骼的牙科设备。本国际标准不包括本质上纯（大于90%）羟基磷灰石的产品。评估包括这些可植入牙科材料的物理化学、机械、生物学和临床方面以及性能。

ISO 22794:2007 applies to implantable materials, whether resorbable or non-resorbable, used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (greater than 90 %) hydroxyapatite are not covered by this International Standard.Evaluation includes the physico-chemical, mechanical, biological and clinical aspects and behaviour of these implantable dental materials.

标准预览图