1.1 本指南旨在解释和澄清RM或认证标准物质（CRM）附带的文件。它解释了基于现有国际标准和指南的CRM分析证书和RMs产品信息文件的内容。本节简要介绍了CRM/RM单元或单元容器以及包含该单元或单元容器的包装上粘贴标签的最低要求。 1.2 本指南提供了有关计算标准差和均方根值的一致值和不确定度估计的一些基本指导，并举例说明了国家计量机构常用的方法和信息来源建议。 1.3 单位- 在适用的情况下，以国际单位制表示的数值应视为标准。 这些值可以追溯到其他高阶参考系统，包括洛氏硬度、pH值和国际标准或同行评审出版物定义的其他系统。 1.4 目录- 本指南中的章节和主题列举如下: 部分 标题 1. 范围 2. 参考文件 3. 术语 4. 指南摘要 5. 意义和用途 6. 分析证书或参考材料文件的内容 7. 标签 8. 技术和统计评估 9 共识值计算程序 10 不确定性估计 11 报告值和不确定性估计 12 国际单位制 13 关键词 附录X1 在零度附近工作 附录X2 工作接近100% 附录X3 经审查的值 附录X4 分析证书章节的语言示例 1.5 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。 1.6 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 本指南旨在供金属和采矿行业的RMs和CRM开发人员使用。 5.2 该指南与统一的程序和要求有关，旨在防止各种各样的文档做法、定义和术语的扩散。 如果本指南中的声明是强制性的，这是因为所述实践是化学计量的基础，而不是CRM/RM开发的基础。 5.3 本指南中的材料旨在补充和澄清ISO指南31的内容，并针对金属和采矿行业的需求提供指导。 5.4 本指南中描述的文件旨在包含用户理解材料所需的最低信息量，以帮助用户判断产品质量，并帮助用户以适当的方式使用产品。本指南和结果文件都不是百科全书。 5.5 由于本文件是一份标准指南，因此旨在教育那些在质量体系范围内参与实验室操作、质量体系开发和维护、标准物质开发和实验室操作认证的人员。 各方必须理解，本指南的内容讨论了可选实践，有许多实现和记录的选择。然而，本指南并不构成评估和认可的要求。一个明显的例子是共识值和不确定性计算的统计评估，它可以采取多种形式，在任何给定情况下都没有单一、正确的选择。 5.6 使用本指南时，CRM开发人员将为正在开发的材料设定目标，例如同质性的目标不确定性和指定值的总体覆盖间隔。这些选择基于CRM的预期用途。材料、性能值及其不确定性可能满足或不满足设定的目标。这些决定是通过专家判断做出的，没有确切的正确或错误、通过或失败的结果应该由外部机构强加。 CRM或RM的质量将由潜在用户来判断，他们需要将CRM或RM用于其测量过程。 5.6.1 CRM用户可能具有的一个要求示例是，认证值的不确定性是否适合将该值用作校准点。CRM用户和生产商可以从标准测试方法或进行相关分析的实验室获得信息。 5.6.2 尽管ISO标准物质委员会（ISO TC334）已将所有标准物质和其他形式的RMs指定为命名标准物质，但本指南使用了公约。经认证的标准物质称为标准物质，没有认证值的标准物质称为RMs。这种做法与指南一致 E2972年 .

1.1 This guide is designed to explain and to clarify documentation that accompanies an RM or a certified reference material (CRM). It explains the contents of certificates of analysis for CRMs and product information documents for RMs, based on existing international standards and guides. It briefly touches on the minimum requirements for a label attached to the CRM/RM unit or unit container and to the package containing the unit or unit container. 1.2 This guide provides some basic guidance on calculation of consensus values and uncertainty estimates for CRMs and RMs with examples of approaches commonly used by national metrology institutes and suggestions for sources of information. 1.3 Units— The values stated in SI units are to be regarded as the standard, whenever applicable. Values can be traceable to other higher-order reference systems, including Rockwell Hardness, pH, and other systems defined by an international standard or peer-reviewed publication. 1.4 Contents— Sections and topics within this guide are enumerated below: Section Title 1 Scope 2 Referenced Documents 3 Terminology 4 Summary of Guide 5 Significance and Use 6 Contents of a Certificate of Analysis or Reference Material Documentation 7 Labels 8 Technical and Statistical Evaluations 9 Procedures for Consensus Value Calculations 10 Estimation of Uncertainty 11 Reporting Values and Uncertainty Estimates 12 International System of Units 13 Keywords Appendix X1 Working Near Zero Appendix X2 Working Near 100 % Appendix X3 Censored Values Appendix X4 Examples of Language for Sections of a Certificate of Analysis 1.5 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. 1.6 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 guide is intended for use by developers of RMs and CRMs for the metals and mining industries. 5.2 The guidance is related to uniform procedures and requirements and is intended to prevent the proliferation of widely varying documentation practices, definitions, and terminology. Where the statements in this guide are made as imperatives, it is because the stated practices are fundamental to chemical metrology, not to CRM/RM development. 5.3 The material in this guide is intended to supplement and to clarify the contents of ISO Guide 31 and to provide guidance specific to the needs of the metals and mining industries. 5.4 The documents described in this guide are intended to contain the minimum amount of information required for a user to understand the material, to help a user judge the quality of the product, and to help a user employ it in appropriate ways. Neither this guide nor resultant documents are meant to be encyclopedic. 5.5 Because this document is a standard guide, it is intended to educate those who are involved in laboratory operation, quality system development and maintenance, reference material development, and accreditation of laboratory operations within the scope of a quality system. It must be understood by all parties that the elements of this guide discuss optional practices having numerous choices for accomplishment and documentation. However, this guide does not constitute requirements for assessment and accreditation. An obvious example is statistical evaluation for consensus value and uncertainty calculations, which can take many forms with no single, correct choice for any given case. 5.6 When using this guide, CRM developers will set goals for the material under development, such as target uncertainties for homogeneity and for overall coverage intervals for assigned values. These choices are based on the intended uses of a CRM. The material, property values, and their uncertainties may or may not meet the set goals. These decisions are made using expert judgement, and there are no exact right or wrong, passing or failing outcomes that should be imposed by outside authorities. The quality of a CRM or RM will be judged by the prospective user, who needs it to use with their measurement process. 5.6.1 An example of a requirement a CRM user may have is whether the uncertainty of a certified value is fit for the purpose of using the value as a calibration point. CRM users and producers can obtain information from standard test methods or from laboratories doing relevant analyses. 5.6.2 Although the ISO Committee on Reference Materials (ISO TC334) has designated all CRMs and other forms of RMs as being named reference materials, this guide uses the convention the certified reference materials are called CRMs and reference materials having no certified values are named RMs. This practice is consistent with Guide E2972 .