测量方法和结果的准确度（真实度和精密度）第3部分：协作研究的中间精密度和替代设计

[中文适用范围]： 本文件提供了以下服务：a) 讨论了确定标准测量方法的正确度和精密度测量（包括再现性、重复性和选定的中间精密度测量）的替代实验设计，包括对其使用必要性或有益情况的回顾，以及对所得估计值的解释和应用的指导，以及 b) 包括具体设计和计算的工作示例。本文件中讨论的每一种替代设计旨在解决以下一个（或几个）问题：a) 讨论中间精密度测量定义的含义；b) 对在实际情况中解释和应用中间精密度测量估计值的指导；c) 确定再现性、重复性和选定的中间精密度测量；d) 改进1) 再现性和其他精密度测量的确定；e) 改进样本均值的估计；f) 确定内部重复性标准差的范围；g) 确定其他精密度成分，如操作员变异性；h) 确定精密度估计的可靠性水平；i) 通过优化精密度估计的可靠性来减少参与实验室的最低数量； j) 避免扭曲重复性估计（分层设计）；k) 避免扭曲再现性估计（考虑到材料的异质性）。通常，在合作研究中评估其精度的方法的性能将在开发该方法的实验室进行的单实验室验证研究中进行评估。在之前的单实验室研究中，将确定确定中间精度的相关因素。1) 允许减少实验室数量。1 [外文原描述]： This document provides a) a discussion of alternative experimental designs for the determination of trueness and precision measures including reproducibility, repeatability and selected measures of intermediate precision of a standard measurement method, including a review of the circumstances in which their use is necessary or beneficial, and guidance as to the interpretation and application of the resulting estimates, and b) worked examples including specific designs and computations. Each of the alternative designs discussed in this document is intended to address one (or several) of the following issues: a) a discussion of the implications of the definitions of intermediate precision measures; b) a guidance on the interpretation and application of the estimates of intermediate precision measures in practical situations; c) determining reproducibility, repeatability and selected measures of intermediate precision; d) improved determination of reproducibility and other measures of precision; e) improving the estimate of the sample mean; f) determining the range of in-house repeatability standard deviations; g) determining other precision components such as operator variability; h) determining the level of reliability of precision estimates; i) reducing the minimum number of participating laboratories by optimizing the reliability of precision estimates; j) avoiding distorted estimations of repeatability (split-level designs); k) avoiding distorted estimations of reproducibility (taking the heterogeneity of the material into consideration). Often, the performance of the method whose precision is being evaluated in a collaborative study will have previously been assessed in a single-laboratory validation study conducted by the laboratory which developed it. Relevant factors for the determination of intermediary precision will have been identified in this prior single-laboratory study.