1.1本规程涵盖了验证经验推导校准（注1）的要求，例如通过多元线性回归（MLR）、主成分回归（PCR）、偏最小二乘（PLS）、人工神经网络（ANN）推导的校准，或任何其他经验校准技术，其中假设为测试中给定样本测量的一组变量与适用于该样本的一个或多个物理、化学、质量或隶属度属性之间的关系。 笔记 1-经验推导的校准有时称为 “ 模型 ” 或 “ 校准。 ” 为了简洁起见，在下文中 “ 标定 ” 可以使用，而不是过程的全名。 1.2本规程不包括建立上述假设关系的程序。 1.3本规程概述了用于验证经验推导的多元校准对测试样本测量的适用性，以及验证根据经验推导的多元校准计算的特性与公认参考测量方法结果之间的等效性，以在为以下目的确定的控制限值内:预先指定的统计置信水平。 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和健康实践，并确定监管限制的适用性。 ====意义和用途====== 本规程概述了一个普遍适用的程序，用于验证相对于公认参考方法的定量或定性、经验推导的多变量校准的性能。 本规程提供了评估校准能力的程序，以提供相对于公认参考方法的可靠估计。 本规程为购买者提供了一种测量系统，该测量系统结合了经验推导的多元校准，并提供了指定验证要求的选项，以确保该系统能够提供与公认参考方法具有适当程度一致性的估计。 本规程为测量系统的用户提供了一种结合经验推导的多元校准的程序，该程序能够提供可能对测量系统性能的持续质量保证有用的信息。 在应用本规程过程中获得的验证信息仅适用于用于执行验证的材料类型和性能范围，并且仅适用于完全应用本规程的单个测量系统。用户有责任选择验证样本的属性级别和成分特征，以使其适合应用。 该实践允许用户为分析仪系统编写一份全面的验证声明，包括验证应用范围的具体限制和测量系统允许使用的具体限制。提醒用户不要将验证结果外推到用于获得这些结果的材料类型和性能范围之外。 用户应注意，经验证的经验衍生多元校准仅适用于验证集中表示的子集总体内的样本。只有明确确定校准适用于产生估计的特定测量时，才能验证经验推导的多元校准的估计。 不能假设适用性。

1.1 This practice covers requirements for the validation of empirically derived calibrations (Note 1) such as calibrations derived by Multiple Linear Regression (MLR), Principal Component Regression (PCR), Partial Least Squares (PLS), Artificial Neural Networks (ANN), or any other empirical calibration technique whereby a relationship is postulated between a set of variables measured for a given sample under test and one or more physical, chemical, quality, or membership properties applicable to that sample. Note 1—Empirically derived calibrations are sometimes referred to as “ models ” or “ calibrations. ” In the following text, for conciseness, the term “ calibration ” may be used instead of the full name of the procedure. 1.2 This practice does not cover procedures for establishing said postulated relationship. 1.3 This practice serves as an overview of techniques used to verify the applicability of an empirically derived multivariate calibration to the measurement of a sample under test and to verify equivalence between the properties calculated from the empirically derived multivariate calibration and the results of an accepted reference method of measurement to within control limits established for the prespecified statistical confidence level. 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 and health practices and determine the applicability of regulatory limitations prior to use. ====== Significance And Use ====== This practice outlines a universally applicable procedure to validate the performance of a quantitative or qualitative, empirically derived, multivariate calibration relative to an accepted reference method. This practice provides procedures for evaluating the capability of a calibration to provide reliable estimations relative to an accepted reference method. This practice provides purchasers of a measurement system that incorporates an empirically derived multivariate calibration with options for specifying validation requirements to ensure that the system is capable of providing estimations with an appropriate degree of agreement with an accepted reference method. This practice provides the user of a measurement system that incorporates an empirically derived multivariate calibration with procedures capable of providing information that may be useful for ongoing quality assurance of the performance of the measurement system. Validation information obtained in the application of this practice is applicable only to the material type and property range of the materials used to perform the validation and only for the individual measurement system on which the practice is completely applied. It is the user's responsibility to select the property levels and the compositional characteristics of the validation samples such that they are suitable to the application. This practice allows the user to write a comprehensive validation statement for the analyzer system including specific limits for the validated range of application and specific restrictions to the permitted uses of the measurement system. Users are cautioned against extrapolation of validation results beyond the material type(s) and property range(s) used to obtain these results. Users are cautioned that a validated empirically derived multivariate calibration is applicable only to samples that fall within the subset population represented in the validation set. The estimation from an empirically derived multivariate calibration can only be validated when the applicability of the calibration is explicitly established for the particular measurement for which the estimation is produced. Applicability cannot be assumed.