稳态输入电流试验能力验证的样品制备与技术分析  

Sample Preparation and Technical Analysis of Proficiency Test of Steady State Input Current

作　　者：卢大伟[1] 陈鸿波[1] 杨昭鹏[1] 段乔峰[1] 路有山 高山[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2014年第7期754-756,共3页Chinese Pharmaceutical Affairs

摘　　要：目的介绍稳态输入电流能力验证项目实施情况,为科学、高效地组织管理全国医疗器械检测机构能力验证提供参考。方法从稳态输入电流能力验证项目中样品制备步骤和技术分析结果两方面进行讨论。结果与结论稳态输入电流能力验证项目中,样品的制备重点在于控制好方案设计、元器件选购、样品组装以及样品稳定性和均匀性考核4个环节。对本次能力验证结果出现的问题进行分析和总结,提示需要进一步加强对标准的理解,对实验仪器进行校准,严格控制试验环境,对检验人员进行相关培训,才能确保试验结果的准确性。Objective To introduce the implementation situation of the project on proficiency test of steady state input current, and to provide reference for the proficiency test for medical device testing institutions. Methods The project on proficiency test of steady state input current was discussed from aspects of the sample preparation method and result analysis. Results and Conclusion The key points of sample preparation lie on the control of the following four links; designing of protocol, purchase of elements, assembly of samples and evaluation of sample stability and uniformity. The analysis and summary of problems found in this proficiency test indicated that further understanding of standards needs to be enhanced and only with calibration of experiment equipment, strict control of experiment environment and related training for inspection personnel can the accuracy of test results be assured.

关 键 词：医疗器械 能力验证 稳态输入电流试验 样品制备 技术分析 

分 类 号：R197.39[医药卫生—卫生事业管理]