标准摘要
[中文适用范围]： 本国际标准适用于口腔颌面外科手术中用作填充和增强骨骼的牙科装置的可吸收或不可吸收的植入材料。 本国际标准不涵盖本质上纯（> 90%）羟基磷灰石的产品。 评估包括这些植入牙科材料的物理化学、机械、生物和临床方面以及行为。 本国际标准不涵盖自体移植物、同种异体移植物和膜等材料，以及主要用途是输送药品的产品。 [外文原描述]： 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.
英文名称Dentistry — Implantable materials for bone filling and augmentation in oral and maxillofacial surgery — Contents of a technical file