A complex mechatronics system Bayesian plan of demonstration test is studied based on the mixed beta distribution. During product design and improvement various information is appropriately considered by introducing i...A complex mechatronics system Bayesian plan of demonstration test is studied based on the mixed beta distribution. During product design and improvement various information is appropriately considered by introducing inheritance factor, moreover, the inheritance factor is thought as a random variable, and the Bayesian decision of the qualification test plan is obtained, and the correctness of a Bayesian model presented is verified. The results show that the quantity of the test is too conservative according to classical methods under small binomial samples. Although traditional Bayesian analysis can consider test information of related or similar products, it ignores differences between such products. The method has solved the above problem, furthermore, considering the requirement in many practical projects, the differences among this method, the classical method and Bayesian with beta distribution are compared according to the plan of reliability acceptance test.展开更多
基金National Advanced Research Project of China(No.51319030302)National Advanced Research Foundation of China(No.9140A 19030506KG0166)
文摘A complex mechatronics system Bayesian plan of demonstration test is studied based on the mixed beta distribution. During product design and improvement various information is appropriately considered by introducing inheritance factor, moreover, the inheritance factor is thought as a random variable, and the Bayesian decision of the qualification test plan is obtained, and the correctness of a Bayesian model presented is verified. The results show that the quantity of the test is too conservative according to classical methods under small binomial samples. Although traditional Bayesian analysis can consider test information of related or similar products, it ignores differences between such products. The method has solved the above problem, furthermore, considering the requirement in many practical projects, the differences among this method, the classical method and Bayesian with beta distribution are compared according to the plan of reliability acceptance test.
文摘目的探讨STAGO全自动血凝仪在人凝血因子活性测定上的应用。方法对STAGO全自动血凝仪按照GMP要求进行安装确认(installation qualification,IQ):实施信息核查并记录;运行确认(operational qualification,OQ):准确度、精密度(批内精密度及批间精密度)、干扰试验及参考范围的验证确认;性能确认(performance qualification,PQ):按STAGO凝血分析仪相关SOP检测6份人凝血因子Ⅷ样品活性,并计算6份样品检测值间的相对标准偏差(relative standard deviation,RSD)。结果已核实STAGO全自动血凝仪基本信息,安装环境及安装过程均符合要求,并已进行记录。厂家提供的正常及病理值质控血清测定3次的均值均在厂家提供的质控范围内;批内及批间精密性的变异系数(coefficient of variation,CV)均<10%;随机组与对照组相比平均偏差<10%;20份体检样本的均值、标准偏差(standard deviation,SD)及结果在正常参考范围的例数与总标本数的比例(R值)>0.9。6份人凝血因子Ⅷ样品检测值的RSD值为1.95%。结论经全面的设备确认,STAGO全自动血凝仪符合人凝血因子活性测定的要求。
