对同种异体骨质量管理体系风险控制重点和存在问题的探讨  

Discussion on the Key Aspects of Risk Control and Problems of Quality Management Systems for Allogeneic Bone Products

作　　者：田少雷[1] 

机构地区：[1]国家食品药品监督管理局药品认证管理中心,北京市100061

出　　处：《中国医疗器械杂志》2012年第5期365-369,共5页Chinese Journal of Medical Instrumentation

摘　　要：从控制同种异体骨在临床使用时存在的潜在风险的角度,探讨对该类产品进行风险控制的措施和质量管理的重点关注环节,并汇总介绍了国内现有生产企业在质量管理体系方面存在的主要问题。From the view of the potential risks of allogeneic bone products in clinical use. the key aspects of risk control and quality management for these products are discussed, as well as the general problems existing in the quality management system of their production enterprises in China are briefly introuduced.

关 键 词：同种异体骨:潜在风险 质量管理体系 风险控制 问题 

分 类 号：R197.31[医药卫生—卫生事业管理]