摘要
目的总结2006~2010年中国食品药品检定研究院组织实施的全国医疗器械检测机构实验室间比对的工作经验。方法共组织5次、17项比对试验。采用稳健统计方法对结果进行判定。结果共发现问题81项,标准理解有误及试验方法有误是导致不满意结果的主要原因。结论通过实验室间比对,有效地提高了医疗器械检测机构的检测能力。
Objective To summarize the interlaboratory comparisons of medical device testing institutions between 2006 to 2010.Methods 17 interlaboratory comparisons of medical device testing（5 times） were done.Robust statistics was used for assessment.Results 81 unsatisfactory results or questionable results were found.Main reasons caused unsatisfactory results and questionable results were that misjudge of the standard and wrong method were used.Conclusion Interlaboratory comparison test is an effective way to improve testing proficiency.
出处
《中国药事》
CAS
2011年第8期785-786,789,共3页
Chinese Pharmaceutical Affairs
关键词
医疗器械
比对试验
质量管理
medical device
interlaboratory
quality management
