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国家食药总局批准发布4项医疗器械行业标准
2017-08-29 10:11:42 中国经济网
经济日报-中国经济网北京8月29日讯 (记者 吴晓薇)记者从国家食品药品监督管理总局获悉,YY/T 1574—2017《组织工程医疗器械产品海藻酸盐凝胶固定或微囊化指南》等4项医疗器械行业标准已经审定通过,并于28日在总局官网公布,该标准自2018年9月1日起实施。
其中,《组织工程医疗器械产品海藻酸盐凝胶固定或微囊化指南》规定了海藻酸盐凝胶固定及其微囊化评价的要求,适用于海藻酸盐凝胶固定及其微囊化的评价。
《组织工程医疗器械产品修复和替代骨组织植入物骨形成活性的评价指南》规定了修复和替代骨组织缺损的植入物骨形成活性的体内评价通则,主要包括不同种属的动物模型和相应的试验程序,以及形态学、组织生物化学和生物力学分析等结果测定和评价方法。适用于修复和替代骨组织缺损的植入物。
《组织工程医疗器械产品可吸收材料植入试验》规定了评价可吸收生物材料组织反应的植入试验方案。适用于临床预期使用中,在骨或软组织内存留时间大于30天而小于3年的可吸收生物材料。
《组织工程医疗器械产品聚合物支架微结构评价指南》给出了组织工程医疗器械产品研发和生产中用作聚合物支架的多孔材料的孔隙尺寸、孔径分布、孔隙率、连通性,以及通透性等性能指标测定试验方法指南。适用于聚合物支架微结构的评价。
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