ISO Guide 35:2017 参考材料 证明用通用和统计学原理

标准编号：ISO Guide 35:2017

中文名称：参考材料 证明用通用和统计学原理

英文名称：Reference materials — Guidance for characterization and assessment of homogeneity and stability

发布日期：2017-08

标准范围

ISO/Guide 35:2017解释了标准物质生产的以下方面的概念并提供了方法:-同质性评估；-稳定性评估和与利益财产相关的可能稳定性问题相关的风险管理；-标准物质特性的表征和赋值；-认证值的不确定度评估；-建立认证财产价值的计量溯源性。给出的指南支持ISO 17034的实施。只要满足ISO 17034的要求，也可以使用其他方法。本文件简要说明了通勤性评估（6.11）的必要性，但未提供任何技术细节。本文简要介绍了定性特性（9.6至9.10）的特征，并提供了对此类材料进行均匀性试验取样的简要指南（第7条）。然而，不包括用于评估标准物质质量特性均匀性和稳定性的统计方法。本文件也不适用于多变量量，如光谱数据。

ISO/Guide 35:2017 explains concepts and provides approaches to the following aspects of the production of reference materials:- 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 a reference material;- the evaluation of uncertainty for certified values;- the establishment of the metrological traceability of certified property values.The guidance given supports the implementation of ISO 17034. Other approaches may 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 9.10) is provided together with brief guidance on sampling such materials for homogeneity tests (Clause 7). However, statistical methods for the assessment of the homogeneity and stability of reference materials for qualitative properties are not covered. This document is also not applicable to multivariate quantities, such as spectral data.

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