现行 YY/T 1679-2021
组织工程医疗器械产品 骨 体内临界尺寸骨缺损的临床前评价指南 组织工程医疗器械产品 骨 体内临界尺寸骨缺损的临床前评价指南 Tissue engineering medical device products—Bone—Standard guide for pre-clinical in vivo evaluation in critical size segmental bone defects
发布日期:2021-03-09
实施日期:2022-04-01
分类信息
研制信息

归口单位: 全国外科植入物和矫形器械标准化技术委员会组织工程医疗器械产品分技术委员会(SAC/TC 110/SC 3)

起草单位: 南方医科大学、 中国食品药品检定研究院、 中国人民解放军总医院

起草人: 欧阳钧、 戴景兴、 杨宇超、 徐丽明、 郭全义、 邵安良

标准简介

本标准规定了预期修复或再生骨组织植入物骨形成活性的体内临界尺寸骨缺损评价通则;对骨缺损动物模型的制备、骨缺损部位及范围、缺损类型、植入物的制备和评价提供了相关参数。本标准适用于部分临界尺寸骨缺损模型的制备,以及合理利用临界尺寸骨缺损模型对具有诱导或促进骨生长的骨组织工程医疗产品的测试和评价

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