標準號：ISO 22794-2007
中文標準名稱：牙科學.口腔和上頜面外科中骨填充物和增加物用植入材料.技術文檔內容
英文標準名稱：Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
標準類型：C33
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C33
國際標準分類號：11.060.15
引用標準：ISO 1942;ISO 10993-1;ISO 10993-17;ISO 11134;ISO 11135-1994;ISO 11137-1995;ISO 11607-2003;ISO 13408-1;ISO 14155-1996;ISO 14937;ISO 14971;ISO 15223-2000;EN 1041
適用范圍：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.