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

Standard Practice for Statistical Assessment and Improvement of Expected Agreement Between Two Test Methods that Purport to Measure the Same Property of a Material


 

 

非常抱歉,我们暂时无法提供预览,您可以试试: 免费下载 ASTM D6708-16 前三页,或者稍后再访问。

您也可以尝试购买此标准,
点击右侧 “立即购买” 按钮开始采购(由第三方提供)。

 

标准号
ASTM D6708-16
发布
2016年
发布单位
美国材料与试验协会
替代标准
ASTM D6708-16a
当前最新
ASTM D6708-24
 
 
适用范围

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......

血管支架脉动疲劳试验系统 徽涛

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,尽可能高 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模拟血管来保证在测试频率下达到预期支架直径Z小值Z大值,或相同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通过支架外径与模拟血管外径之间关系换算得到支架外径。...

药监局:基因测序仪临床评价注册审查指导原则等3项

(6)统计分析  应选择合适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/已上市同类产品一致性评价,一般选择2×2四格表形式总结两种产品检测结果,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。  ...

国家药监局发文 疫苗一致性评价来了!

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、病毒滴度上下限范围等)有效性下限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。  免疫原性评价指标标准参照前述随机对照临床试验。  ...

HIV初筛实验室室间质量评价标准操作程序

免疫测定方法灵敏度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,维持标准化操作一个管理过程。这一过程是通过一个反馈环路进行:1、确定控制对象;2、规定控制对象标准预期值);3、制定或选择控制方法手段;4、测量实际数据;5、比较或较对实际数据与预期之间差异,并说明原因。...


谁引用了ASTM D6708-16 更多引用





Copyright ©2007-2022 ANTPEDIA, All Rights Reserved
京ICP备07018254号 京公网安备1101085018 电信与信息服务业务经营许可证:京ICP证110310号