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ISO Guide 35:2017, Reference materials – Guidance for characterization and assessment of homogeneity and stability

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Type of Publication:

Document Date:

2022-08-19

The production of reference materials (RMs) is a key activity for the improvement and maintenance of a worldwide coherent measurement system. As detailed in ISO Guide 33[1], RMs with different characteristics are used in measurements, such as calibration, quality control, proficiency testing and method validation, as well as for the assignment of values to other materials. Certified reference materials (CRMs) are also used to confirm or establish metrological traceability to conventional scales, such as the octane number, hardness scales and pH.

To be comparable across borders and over time, measurements need to be traceable to appropriate and stated references. CRMs play a key role in implementing the concept of traceability of measurement results in chemistry, biology and physics among other sciences dealing with substances and materials. Laboratories use these CRMs as readily accessible measurement standards to establish traceability of their measurement results to International Standards. The property values carried by a CRM can be made traceable to the International System of Units (SI) or other internationally agreed references during production. This document explains how approaches can be developed that will lead to well established property values, which are made traceable to appropriate stated references.