標準號：DIN EN ISO 22794-2009
中文標準名稱：牙科.口腔和上頜面外科中骨填充物和增加物用可植入材料.技術文檔內容(ISO 22794:2007,修正版本 2009-01-15),德文版本 EN ISO 22794:2009
英文標準名稱：Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file (ISO 22794:2007, corrected version 2009-01-15); English version of DIN EN ISO 22794:2009-11
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 10993-1;ISO 10993-17;ISO 11135-1;ISO 1942;ISO 11137-1;ISO 11607-2;ISO 13408-1;ISO 14155-1;ISO 14155-2;ISO 14937
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 ciinical 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.