经生产企业核准盖章的技术报告，（包括 ①产品背景介绍：国内外研究动态和

经生产企业核准盖章的技术报告，（包括 ①产品背景介绍：国内外研究动态和应用研究资料；
②产品概述：分类信息、适用范围、产品理化性能和生物性能；
③产品安全性资料：产品组成成分及各成分安全性信息；
④产品工艺介绍：生产环境要求、工艺流程说明和产品中各试剂残留分析；
⑤产品稳定性研究；
⑥产品生物相容性和动物实验内容等等）

結果 (英文) 1:

Technical report approved by the manufacturer and sealed (including ① product Backgrounder: research and applied research and information; Products Overview: a category of information, scope of application, physical and chemical properties and biological properties; ③ product safety information: the composition and the composition of the product safety information; ④ product technology introduction: the production of reagents in environmental requirements, process descriptions, and product residue analysis; ⑤ products stability; ⑥ product biocompatibility and animal experiments, and so on)

結果 (英文) 3:

By the production enterprise approved and stamped by the technical report (including product background of the domestic and foreign research dynamic and application of data;
2 Product Overview: information classification, scope of application, product physical and chemical properties and biological properties;
3 product safety data: product components and the component safety information;
4, the product process is introduced: requirements in a manufacturing environment, the process description and product in the kit residue analysis;
the product stability studies;
6 biological product compatibility and animal experiment content and so on)