参考材料 均匀性和稳定性的表征和评估方法

[中文适用范围]： 本文件解释了标准物质 (RM) 生产以下方面的概念并提供了方法： — 均匀性评估； — 稳定性评估和与目标属性相关的可能稳定性问题相关的风险管理； — RM 属性的表征和赋值； — 认证值的不确定度评估； — 建立认证值的计量可追溯性。给出的指导支持实施 ISO 17034。只要满足 ISO 17034 的要求，也可以使用其他方法。本文件提供了关于可互换性评估必要性的简要指导 (6.11)，但没有提供技术细节。提供了定性特性表征的简要介绍 (9.6 至 9.8)，以及对此类材料进行均匀性测试的简要指导 (7.4.1.2)。但是，未涵盖用于评估定性特性的 RM 均匀性和稳定性的统计方法。本文件也不适用于多变量，例如光谱数据。注：ISO 33406 提供了有关具有一个或多个定性属性值的 RM 生成的更多信息。 [外文原描述]： This document explains concepts and provides approaches to the following aspects of the production of reference materials (RMs): — the assessment of homogeneity; — the assessment of stability and the management of the risks associated with possible stability issues related to the properties of interest; — the characterization and value assignment of properties of an RM; — the evaluation of uncertainty for certified values; — the establishment of the metrological traceability of certified values. The guidance given supports the implementation of ISO 17034. Other approaches can also be used as long as the requirements of ISO 17034 are fulfilled. Brief guidance on the need for commutability assessment (6.11) is given in this document, but no technical details are provided. A brief introduction for the characterization of qualitative properties (9.6 to 9.8) is provided, together with brief guidance on sampling such materials for homogeneity tests (7.4.1.2). However, statistical methods for the assessment of the homogeneity and stability of RMs for qualitative properties are not covered. This document is also not applicable to multivariate quantities, such as spectral data. NOTE ISO 33406 gives more information on the production of RMs with one or more qualitative property values.