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Standard Practice for Statistical Analysis of One-Sample and Two-Sample Interlaboratory Proficiency Testing Programs 一个样品和两个样品实验室间能力验证程序的统计分析的标准实施规程
发布日期: 2021-12-01
1.1 本规程描述了从实验室间能力验证计划中获得的实验室结果的统计分析方法。按照惯例 E1301 能力验证是使用实验室间比较来确定实验室测试或测量性能。相反,协作研究(或协作试验)是使用实验室间比较来确定试验方法的精度,如实践所涵盖 E691 . 1.1.1 方法A包括使用通过测试单个样品获得的单个测试结果的测试程序(每个实验室提交一个测试结果)。 1.1.2 方法B包括使用通过测试两个样本获得的配对测试结果的测试程序(每个实验室为两个样本中的每一个提交一个测试结果)。 两个样品应为相同材料或两种足够相似的材料,以便在测试结果中具有大致相同的变化程度。 1.2 方法A和B适用于包含至少10个参与实验室的能力验证计划。 1.3 这些方法为根据单个实验室试验结果出现的相对可能性对其性能进行评估和分类,以及确定与重复性和再现性相关的试验变化估计提供了方向。假设大多数参与实验室正确执行测试方法,并且样品具有足够的同质性,测试结果代表从基本相同材料的每个实验室测试中获得的结果。 每个实验室收到相同的指示或协议。 1.4 本标准并非旨在解决与其使用相关的所有安全问题(如有)。本标准的用户有责任在使用前制定适当的安全、健康和环境实践,并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒(TBT)委员会发布的《关于制定国际标准、指南和建议的原则的决定》中确立的国际公认标准化原则制定的。 ====意义和用途====== 5.1 本规程旨在描述用于能力验证项目的简单稳健统计方法。 5.2 能力验证计划可以使用本规程中的方法来比较从一组参与实验室获得的测试结果。本规程描述了使用四分位范围和Tukey内外围栏评估单个实验室结果。 5.3 此外,在能力验证计划中获得的数据可能包含有关重复性(实验室内)和再现性(实验室间)测试变化的信息。只有当程序使用多个样本时,重复性信息才可能存在。参见方法B。能力验证项目的参与者数量通常比进行实验室间研究以确定测试方法精度(如实践中所述)的参与者数量更多 E691 ). 能力验证项目中为更多参与者获得的精度估计,以及相应的更广泛的测试条件变化,可以为标准开发人员提供有关测试结果精度的有用信息,该测试结果在一般测试社区中实际使用时可预期用于测试方法。 5.4 为了估计测试方法的精度,参与者必须使用相同的测试方法来获得其测试结果,并且测试必须在重复性和再现性所需的条件下进行。精度估算适用于测试程序中包含的性能水平和材料类型。对于不同的材料类型和不同的性能水平,测试方法的精度可能会有很大差异。 5.5 该实践可能对能力验证项目管理员有用,并提供了统计方法的示例,同时解释了所建议的分析方法的一些优点。本实施规程中所述方法的应用所产生的分析可由实验室用作其质量控制程序的一部分,认证机构可协助评估实验室性能,和ASTM国际技术委员会(以及负责编写、维护或改进试验方法的其他组织)获取有关再现性和重复性的信息。 5.6 现有的能力验证程序有多种类型,有许多方法用于分析实验室间测试产生的数据。 本实践的目的不是质疑使用其他分析方法的程序的完整性。使用一个或多个样本的重复测试的测试程序(每个实验室为每个样本提交两个或多个结果)直接用于实践 E691 或其他用于描述可能更适合该类型程序的分析方法的实践。
1.1 This practice describes methods for the statistical analysis of laboratory results obtained from interlaboratory proficiency testing programs. As in accordance with Practice E1301 , proficiency testing is the use of interlaboratory comparisons for the determination of laboratory testing or measurement performance. Conversely, collaborative study (or collaborative trial) is the use of interlaboratory comparisons for the determination of the precision of a test method, as covered by Practice E691 . 1.1.1 Method A covers testing programs using single test results obtained by testing a single sample (each laboratory submits a single test result). 1.1.2 Method B covers testing programs using paired test results obtained by testing two samples (each laboratory submits one test result for each of the two samples). The two samples should be of the same material or two materials similar enough to have approximately the same degree of variation in test results. 1.2 Methods A and B are applicable to proficiency testing programs containing a minimum of 10 participating laboratories. 1.3 The methods provide direction for assessing and categorizing the performance of individual laboratories based on the relative likelihood of occurrence of their test results, and for determining estimates of testing variation associated with repeatability and reproducibility. Assumptions are that a majority of the participating laboratories execute the test method properly and that samples are of sufficient homogeneity that the testing results represent results obtained from each laboratory testing essentially the same material. Each laboratory receives the same instructions or protocol. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 5.1 This practice is specifically designed to describe simple robust statistical methods for use in proficiency testing programs. 5.2 Proficiency testing programs can use the methods in this practice for the purpose of comparing testing results obtained from a group of participating laboratories. The practice describes evaluation of individual laboratory results using the interquartile range and Tukey inner and outer fences. 5.3 In addition, the data obtained in proficiency testing programs may contain information regarding repeatability (within-lab) and reproducibility (between-lab) testing variation. Repeatability information is possible only if the program uses more than one sample. See Method B. Proficiency testing programs often have a greater number of participants than might be available for conducting an interlaboratory study to determine the precision of a test method (such as described in Practice E691 ). Precision estimates obtained for the larger number of participants in a proficiency testing program, along with the corresponding wider variation of test conditions, can provide useful information to standards developers regarding the precision of test results that can be expected for a test method when in actual use in the general testing community. 5.4 To estimate the precision of a test method, the participants must use the same test method to obtain their test results, and testing must be performed under the conditions required for repeatability and reproducibility. The precision estimates are applicable to the property levels and material types included in the testing program. The precision of a test method may vary considerably for different material types and at different property levels. 5.5 This practice may be useful to proficiency testing program administrators and provides examples of statistical methods along with explanations of some of the advantages of the suggested methods of analysis. The analyses resulting from the application of methods described in this practice may be used by laboratories as part of their quality control procedures, accrediting bodies to assist in the evaluation of laboratory performance, and ASTM International technical committees (and other organizations charged with the task of writing, maintaining, or improving test methods) to obtain information regarding reproducibility and repeatability. 5.6 There are many types of proficiency testing programs in existence and many methods exist for analyzing the data resulting from the interlaboratory testing. It is not the intention of this practice to call into question the integrity of programs using other methods of analysis. Testing programs using replicate testing of one or more samples (each laboratory submits two or more results for each sample) are directed to Practice E691 or other practices for the description of a method of analysis that may be more suitable to that type of program.
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归口单位: E11.20
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