摘要
对全自动生化分析仪进行分析性能实验评价,旨在为其他实验室在ISO15189医学实验室认可或其他评审前,提供一个仪器设备分析性能评价方案。对照YY/T 0654-2017《全自动生化分析仪》和ISO15189:2012《医学实验室质量和能力认可准则》,贝克曼AU680的仪器分析性能在温控系统、加样系统和检测系统均达到临床检测标准要求,可以用于临床测试。
Through analysis of the automatic biochemical analyzer performance experiment evaluation,which is aim to provide a equipment analysis of the performance evaluation scheme for other LABS before ISO15189 medical laboratory accreditation or other review.Pharmaceutical industry standard(YY/T0654-2017:Automatic biochemical analyzer),and Accreditation Criteria for the Quality and Competence of Medical Laboratories(ISO 15189:2012)were used for comparison.The performance experiment evaluation of incubation system,sampling system and optical detection system showed that Beckman AU680 instrument analysis performance have reached the requirements of clinical testing standards,which can be applied in clinical test.
作者
宋学东
李守霞
Song Xuedong;Li Shouxia(Department of Clinical Laboratory,Central Hospital of Handan,Handan 056001)
出处
《现代科学仪器》
2022年第2期41-45,共5页
Modern Scientific Instruments
基金
河北省邯郸市百人创新团队研究计划项目(邯卫党字[2019]34号)。
