1.1 本实践提供了对来自两个测试结果来源的数值数据进行等效性研究的统计方法，以确定它们的真实平均值、方差或其他参数的差异是否不超过预定限度。 1.2 应用包括（ 1 ）相对于公认参考值偏倚的等效性研究，（ 2 ）确定实验室内两种测试方法、测试设备、仪器、试剂源或操作员的等效性或方法转移中两个实验室的等效性，以及（ 3 )确定修改的测试程序相对于当前测试程序在性能特征方面的非劣效性。 1.3 本标准中的指南适用于在给定测试结果水平下对单一材料进行的实验，或对涵盖选定测试结果范围的多种材料进行的实验。1.4 为确定等效性研究所需的数据量提供了指导。讨论了与等效性决策相关的风险控制。 1.5 以SI单位表示的值将被视为标准值。本标准不包括其他计量单位。 1.6 本标准并不旨在解决与其使用相关的所有安全性问题（如果有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践并确定法规限制的适用性。 1.7 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》中确立的国际公认的标准化原则制定的。======意义和用途====== 4.1 进行常规测试的实验室不断需要改进其测试流程。在这些情况下，必须证明任何变化都不会导致测试结果与当前测试过程的不良变化，也不会实质性地影响 性能特征 测试方法。本标准为证明修改后的测试过程的测试结果与当前测试过程的结果等效所需的实验和统计方法提供了指导，其中 对等 定义为在规定限度内的协议，称为 等效极限 . 4.1.1 等效性限度代表最差情况下的差异或比率，在等效性试验前确定，其值通常由受试者共识设定-物质专家。 4.1.2 对测试过程的修改的示例包括但不限于以下: (1) 试验方法程序步骤中操作水平的变更， (2) 安装新的仪器、设备或试剂和测试材料来源， (3) 执行测试的新人员的评估，以及 (4) 将测试转移到新地点。 4.1.3 可直接应用于测试方法的性能特征的实例包括偏差、精密度、灵敏度、特异性、线性和范围。其他特征是测试成本和进行测试程序所需的经过时间。 4.2 等效性研究通过设计实验进行，该实验根据常规测试的相同类型材料的修改和当前测试程序生成测试结果。实验的设计取决于所需的等效类型，如下所述。各种目标的实验设计和执行在第节中讨论 5 . 4.2.1 手段等价 涉及由于测试过程中的修改而导致的平均测试结果在任一方向上的潜在偏移。在重复性条件下，通过对相同材料的改进和当前测试工艺生成测试结果，并评估其平均测试结果的差异。 4.2.1.1 在不能在重复性条件下进行测试的情况下，例如使用在线仪器，测试结果可以在来自修改的和当前的测试过程的成对的测试结果中生成，并且评估成对的测试结果之间的平均差异。4.2.2 斜率当量 评估两个检测程序的检测结果之间线性统计关系的斜率。如果斜率等于值一（1），则两个测试过程满足斜率等效性。 4.2.3 范围等效性 评估选定的更广泛测试结果的平均值差异，实验使用涵盖该范围的材料。斜率等价和均值等价的组合定义了范围等价。 4.2.4 非劣效性 仅与修改后的测试程序与当前测试程序的性能特征的较差结果方向上的差异有关。非劣效性可能涉及平均值、标准偏差或其他统计参数的比较。4.2.4.1 非劣效性研究可能涉及改良程序和现行程序之间性能特征的权衡。例如，修改的过程在测定灵敏度或精确度方面可能略逊于已建立的过程，但可能具有抵消优势，例如更快地传递测试结果或更低的测试成本。 4.3 风险管理- 为确定控制在接受或拒绝等效性时做出错误决定的风险所需的数据量提供了指导（见 5.4 和部分 A1.2 ). 4.3.1 The 消费者风险 是虚假声明等价的风险。与该风险相关的概率被直接控制在低水平，以便接受等效性可以高度保证真实差异小于等效性极限。4.3.2 The 生产者风险 是错误拒绝等价的风险。与这种风险相关的概率由实验产生的数据量控制。如果有效的改进被等效性测试拒绝，这可能会导致公司及其实验室（生产商）的机会损失，或者导致在改进测试过程中不必要的额外努力。

1.1 This practice provides statistical methodology for conducting equivalence studies on numerical data from two sources of test results to determine if their true means, variances, or other parameters differ by no more than predetermined limits. 1.2 Applications include ( 1 ) equivalence studies for bias against an accepted reference value, ( 2 ) determining means equivalence of two test methods, test apparatus, instruments, reagent sources, or operators within a laboratory or equivalence of two laboratories in a method transfer, and ( 3 ) determining non-inferiority of a modified test procedure versus a current test procedure with respect to a performance characteristic. 1.3 The guidance in this standard applies to experiments conducted either on a single material at a given level of the test result or on multiple materials covering a selected range of test results. 1.4 Guidance is given for determining the amount of data required for an equivalence study. The control of risks associated with the equivalence decision is discussed. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 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. 1.7 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 ====== 4.1 Laboratories conducting routine testing have a continuing need to make improvements in their testing processes. In these situations it must be demonstrated that any changes will neither cause an undesirable shift in the test results from the current testing process nor substantially affect a performance characteristic of the test method. This standard provides guidance on experiments and statistical methods needed to demonstrate that the test results from a modified testing process are equivalent to those from the current testing process, where equivalence is defined as agreement within a prescribed limit, termed an equivalence limit . 4.1.1 The equivalence limit, which represents a worst-case difference or ratio, is determined prior to the equivalence test and its value is usually set by consensus among subject-matter experts. 4.1.2 Examples of modifications to the testing process include, but are not limited, to the following: (1) Changes to operating levels in the steps of the test method procedure, (2) Installation of new instruments, apparatus, or sources of reagents and test materials, (3) Evaluation of new personnel performing the testing, and (4) Transfer of testing to a new location. 4.1.3 Examples of performance characteristics directly applicable to the test method include bias, precision, sensitivity, specificity, linearity, and range. Additional characteristics are test cost and elapsed time needed to conduct the test procedure. 4.2 Equivalence studies are performed by a designed experiment that generates test results from the modified and current testing procedures on the same types of materials that are routinely tested. The design of the experiment depends on the type of equivalence needed as discussed below. Experiment design and execution for various objectives is discussed in Section 5 . 4.2.1 Means equivalence is concerned with a potential shift in the mean test result in either direction due to a modification in the testing process. Test results are generated under repeatability conditions by the modified and current testing processes on the same material, and the difference in their mean test results is evaluated. 4.2.1.1 In situations where testing cannot be conducted under repeatability conditions, such as using in-line instrumentation, test results may be generated in pairs of test results from the modified and current testing processes, and the mean differences among paired test results are evaluated. 4.2.2 Slope equivalence evaluates the slope of the linear statistical relationship between the test results from the two testing procedures. If the slope is equivalent to the value one (1), then the two testing processes meet slope equivalence. 4.2.3 Range equivalence evaluates the differences in means over a selected wider range of test results and the experiment uses materials that cover that range. The combination of slope equivalence and means equivalence defines range equivalence. 4.2.4 Non-inferiority is concerned with a difference only in the direction of an inferior outcome in a performance characteristic of the modified testing procedure versus the current testing procedure. Non-inferiority may involve the comparisons of means, standard deviations, or other statistical parameters. 4.2.4.1 Non-inferiority studies may involve trade-offs in performance characteristics between the modified and current procedures. For example, the modified process may be slightly inferior to the established process with respect to assay sensitivity or precision but may have off-setting advantages such as faster delivery of test results or lower testing costs. 4.3 Risk Management— Guidance is provided for determining the amount of data required to control the risks of making the wrong decision in accepting or rejecting equivalence (see 5.4 and Section A1.2 ). 4.3.1 The consumer’s risk is the risk of falsely declaring equivalence. The probability associated with this risk is directly controlled to a low level so that accepting equivalence gives a high degree of assurance that the true difference is less than the equivalence limit. 4.3.2 The producer’s risk is the risk of falsely rejecting equivalence. The probability associated with this risk is controlled by the amount of data generated by the experiment. If valid improvements are rejected by equivalence testing, this can lead to opportunity losses to the company and its laboratories (the producers) or cause unnecessary additional effort in improving the testing process.