外科植入物领域团体标准发展探讨  

Discussion on the Development of Association Standards in the Field of Surgical Implants

作　　者：乔嘉琪 李佳 李立宾 QIAO Jia-qi;LI Jia;LI Li-bin(Tianjin Medical Device Quality Supervision and Test Center)

机构地区：[1]天津市医疗器械质量监督检验中心

出　　处：《中国标准化》2023年第22期77-81,共5页China Standardization

摘　　要：本文介绍了外科植入物和矫形器械领域国家标准和行业标准现状及外科植入物领域团体标准状况,并结合外科植入物行业发展特色,依据国家促进和规范团体标准发展有关政策及法规要求,对外科植入物领域团体标准的发展和定位做出一些初步探讨。This article introduces the current status of national and sectoral standards in the fi eld of surgical implants and orthopaedic devices,as well as the situation of association standards in the fi eld of surgical implants.Combined with the characteristics of surgical implants industry,and according to the relevant national policies and regulations to promote and regulate the development of association standards,some preliminary discussions are made on the development and orientation of association standards in the fi eld of surgical implants.

关 键 词：外科植入物 标准化 团体标准 

分 类 号：R318.08[医药卫生—生物医学工程] F203[医药卫生—基础医学]