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DIN EN ISO 22794-2009

牙科 口腔和上颌面外科中骨填补物与增加物用可植入材料 技术文件的内容

Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file

适用范围: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 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.

实施日期: 2009-11-01

中标分类号: C33 - 医药、卫生、劳动保护 - 口腔科器械、设备与材料

ICS分类号: 11.060.15 - 医药卫生技术

标准组织: DIN - 德国国家标准学会标准

全文来源: WF

英文关键词: Augmentation material Biocompatibility Biological Chemical composition Chemical properties Compatibility Contents Data of the manufacturer Definitions Dental implants Dental materials Dentistry Documentations Evaluations Face (anatomy) Implants (surgical) Oral cavity Orthodontics Physical properties Production Regenerative Specification (approval) Sterilization (hygiene) Surgery Technical data sheets Technical documents Tissue

语种: 汉语

页数: 18

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