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作 者:韩倩倩[1] 薛彬 王涵[1] 史建峰[1] 王迎[1] 汤京龙[1] 王春仁[1] HAN Qianqian;XUE Bin;WANG Han;SHI Jianfeng;WANG Ying;TANG Jinglong;WANG Chunren(Medical Device Control, National Institute of Food and Drug Control, CFDA, Beijing 102629, China)
出 处:《组织工程与重建外科杂志》2017年第6期343-345,共3页Journal of Tissue Engineering and Reconstructive Surgery
摘 要:严重创伤和骨肿瘤切除所导致的骨缺损,是无法自行愈合修复的,需要施加外源性骨诱导材料才可得以有效恢复。在医疗器械分类管理方面,外源性骨诱导材料归三类医疗器械管理。在产业化方面,已有获得注册证的骨填充材料。本文对现有可用于骨组织工程的材料进行整理,包含人工合成无机材料、人工合成高分子材料和天然高分子材料,以及复合材料等。Clinically,the bone defects may be caused by acutely trauma and bone tumor resection.In this situation,the self-repairing capability could not be enough for bone regeneration.The materials for bone regeneration are used for filling bone defects and induce bone repair.In the medical device registration regulation,these materials are belong to the classⅢmedical device.There are several products which had registration license of CFDA.In this paper,the materials used for the production of bone inducing products were summarized,including artificial inorganic materials,artificial polymer materials,natural polymer materials and composite materials.
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