ASTM D6708-16由美国材料与试验协会 US-ASTM 发布于 2016。
ASTM D6708-16在国际标准分类中归属于: 75.080 石油产品综合。
ASTM D6708-16 测量某种材料相同性能的两种试验方法之间预期一致性的统计评价和改进的标准实施规程的最新版本是哪一版?
最新版本是 ASTM D6708-24 。
5.1 This practice can be used to determine if a constant, proportional, or linear bias correction can improve the degree of agreement between two methods that purport to measure the same property of a material.
5.2 The bias correction developed in this practice can be applied to a single result (X) obtained from one test method (method X) to obtain a predicted result ( Y^) for the other test method (method Y).
Note 6: Users are cautioned to ensure that Y^ is within the scope of method Y before its use.
5.3 The between methods reproducibility established by this practice can be used to construct an interval around Y^ that would contain the result of test method Y, if it were conducted, with about 958201;% confidence.
5.4 This practice can be used to guide commercial agreements and product disposition decisions involving test methods that have been evaluated relative to each other in accordance with this practice.
5.5 The magnitude of a statistically detectable bias is directly related to the uncertainties of the statistics from the experimental study. These uncertainties are related to both the size of the data set and the precision of the processes being studied. A large data set, or, highly precise test method(s), or both, can reduce the uncertainties of experimental statistics to the point where the “statistically detectable” bias can become “trivially small,” or be considered of no practical consequence in the intended use of the test method under study. Therefore, users of this practice are advised to determine in advance as to the magnitude of bias correction below which they would consider it to be unnecessary, or, of no practical concern for the intended application prior to execution of this practice.
Note 7: It should be noted that the determination of this minimum bias of no practical concern is not a statistical decision, but rather, a subjective decision that is directly dependent on the application require......
1 生理压力测试方法——该方法要求模拟血管在生理压力、脉动速度,和尽可能高的 测试频率下具有与自体血管相似的顺应性; 2 直径控制方法:该测试方法需要使用直径测试系统和模拟血管来保证在测试频率下达到预期的支架直径的Z小值和Z大值,或相同的直径变化量以及支架平均直径。无法直接测量支架时,可以通过测量模拟血管外径和通过支架外径与模拟血管外径之间关系的换算得到支架外径。...
(6)统计分析 应选择合适的统计方法对临床试验结果进行统计分析,对于试验医疗器械与参考方法/已上市同类产品的一致性评价,一般选择2×2四格表的形式总结两种产品的检测结果,并据此计算灵敏度/特异度、阳性/阴性符合率、Kappa值等指标及其95%置信区间。 对于不一致样本,应进行原因分析。如临床试验方案规定采用其他方法进行确认,则确认结果不应纳入统计分析。 ...
临床一致性比较批次研究数据将为质量标准中关键检定项目的限度(如抗原含量/效价、病毒滴度上下限的范围等)的有效性下限和安全性上限提供支持,保证质量标准科学、合理,从而进一步保证上市疫苗安全有效,质量可控。 免疫原性评价的指标和标准参照前述的随机对照临床试验。 ...
免疫测定方法的灵敏度和特异性要比生化方法高得多,因此QC手段不能照搬生化模式。质量控制是监视ELISA操作全过程,排除误差,维持标准化操作的一个管理过程。这一过程是通过一个反馈环路进行的:1、确定控制的对象;2、规定控制对象的标准(预期值);3、制定或选择控制方法和手段;4、测量实际数据;5、比较或较对实际数据与预期值之间的差异,并说明原因。...
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