人体植入器械质量跟踪实践  

Practice of the Quality Trace for Implant in a Human Body

作　　者：李雪原[1] 李铁玲[1] 潘艳平[1] 

机构地区：[1]承德医学院附属医院,河北承德067000

出　　处：《医疗设备信息》2007年第12期66-68,共3页Information of Medical Equipment

摘　　要：人体植入器械用后质量跟踪,产品及相关各方数据信息的准确性、有效性、一致性及可追溯性,对于术后随访、科研资料利用,以至于做为法律凭证都是必要的。本文具体介绍了相关规定和实践中的操作方法。The system of the quality trace for implant in a human body after the operation should be easy to carry out. The product and interrelated data＇s accuracy, validity, unanimity and .traceableness are essential for the follow-up survey of the results of the operation and making use of scientific research materials, even as legal evidences. This article describes specifically the relevant rules and the operating methods in practice.

关 键 词：植入器械 质量跟踪 高值医用耗材 

分 类 号：R197.323[医药卫生—卫生事业管理]