1.1 本指南描述了金属、矿石和相关材料分析实验室使用的化学和光谱化学分析测试方法的验证程序。 1.2 本指南可适用于实验室开发（内部）方法的验证、向现有标准试验方法中添加分析物、现有标准方法的变化或范围扩展，或使用新的或不同的实验室设备。 1.3 本指南中建议的方法也可用于验证采矿、矿石加工和金属行业实验室常规使用的标准测试方法的实施。 1.4 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====== 4.1 方法验证是证明方法满足所需性能的过程。ISO/IEC 17025等国际标准、认证机构和监管机构要求有证据证明分析方法能够产生有效结果。 这适用于使用已发布标准试验方法、修改标准试验方法和内部试验方法的实验室。 4.2 虽然协作研究是本指南的一部分，但当正式协作研究不可行时，单个实验室可以使用本指南进行方法验证。本指南也可在全面合作研究之前应用，以预测方法的可靠性。 4.3 本指南中描述的多种验证技术的使用增加了对方法有效性或应用的信心。 4.4 在第节中全面描述基本注意事项超出了本指南的范围 5. . 有关这些概念的更具描述性的定义，请参阅国际纯化学和应用化学联合会（IUPAC）技术报告“分析方法单实验室验证协调指南” 5. 这个 分析术语纲要 （橙色书籍）， 6. 和Eurachem出版物， 分析方法的适用性、方法验证实验室指南和相关主题 . 7.

1.1 This guide describes procedures for the validation of chemical and spectrochemical analytical test methods that are used by a metals, ores, and related materials analysis laboratory. 1.2 This guide may be applied to the validation of laboratory developed (in-house) methods, addition of analytes to an existing standard test method, variation or scope expansion of an existing standard method, or the use of new or different laboratory equipment. 1.3 The suggested approaches in this guide may also be used to validate the implementation of standard test methods used routinely by laboratories of the mining, ore processing, and metals industry. 1.4 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 Method validation is a process of demonstrating that the method meets the required performance capabilities. International standards such as ISO/IEC 17025, certifying bodies, and regulatory agencies require evidence that analytical methods are capable of producing valid results. This applies to laboratories using published standard test methods, modified standard test methods, and in-house test methods. 4.2 Although a collaborative study is part of this guide, this guide may be used by a single laboratory for method validation when a formal collaboration study is not practical. This guide may also be applied before a full collaboration study to predict the reliability of the method. 4.3 The use of multiple validation techniques described in this guide increases confidence in the validity or application of the method. 4.4 It is beyond the scope of this guide to describe fully the fundamental considerations in Section 5 . For a more descriptive definition of these concepts, refer to the International Union of Pure and Applied Chemistry (IUPAC) technical report, “Harmonized Guidelines for Single Laboratory Validation of Methods of Analysis,” 5 the IUPAC Compendium of Analytical Nomenclature (Orange Book), 6 and the Eurachem publication, The Fitness for Purpose of Analytical Methods, A Laboratory Guide to Method Validation and Related Topics . 7