GB/T 15000.3-2008 Directives for the work of reference materials(3).Reference materials.General and statistical principles for certification (English Version)
The statistical principles given in this section are intended to aid in the understanding and development of effective methods for assigning values to reference sample properties, including methods for assessing relative uncertainties and establishing metrological traceability. A reference sample (RM) prepared by following all the steps described in this section is usually accompanied by a certificate and is called a certified reference sample (CRM). This section will help to realize the full potential of CRM to ensure comparability, accuracy and consistency of measurement results at national or international level. To be comparable in space and time, measurements need to be traceable to appropriate and prescribed measurement standards. In chemistry, biology and physics, especially in disciplines involving materials and/or samples, CRM plays an important role in establishing the traceability of measurement results. Laboratories use CRM as an easily accessible measurement standard to establish the traceability of their measurement results to international standards. During the CRM production process, its characteristic values can be traced to SI units or other internationally agreed units. This section clarifies how to develop a method for determining the value of a property so well that it is traceable to an appropriate and prescribed measurement standard. This standard applies to a wide range of materials (matrixes) ranging from gas mixtures to biological samples, and also to properties ranging from chemical composition to physical and immunological assay properties. The methods described in this section are not necessarily applicable to all aspects of RM production and determination of characteristic values (including associated uncertainties). It can be considered that the method given in this section is the main method for the production and assignment of most RMs, and appropriate amendments may be required for some special cases. The statistical methods described in this section illustrate the outline of the method by way of example and assume that the data are normally distributed. When the data is not normally distributed, it is better to use other statistical methods to obtain effective characteristic values and corresponding uncertainties. This section also outlines the design of a production CRM solution.
GB/T 15000.3-2008 Referenced Document
GB/T 15000.4-2003 Directives for work of reference materials(4) Contents of certificates and labels
GB/T 15000.7-2001 Directives for the work of reference materials(7) General requirements for the competence of reference material producers
GB/T 15000.8-2003 Directives for the work of reference materials(8) Uses of certified reference materials
GB/T 3358.1-1993 Terms for statistics. Part 1: Terms for general statistics
GB/T 6379.1-2004 Accuracy(trueness and precision)of measurement methods and results Part 1:General principles and definitions
GB/T 6379.2-2004 Accuracy(trueness and precision)of measurement methods and results-Part 2:Basic method for the determination of repeatability and reproducibility of a standard measurement method
GB/T 6379.4-2006 Accuracy(trueness and precision) of measurement methods and results-Part 4:Basic methods for the determination of the trueness of a standard measurement method
GB/T 15000.3-2008 history
2023GB/T 15000.3-2023 Standard sample working guidelines part 3: Standard sample determination and homogeneity and stability evaluation
2008GB/T 15000.3-2008 Directives for the work of reference materials(3).Reference materials.General and statistical principles for certification
1994GB/T 15000.3-1994 Directives for the work of reference materiapls (3). General principles and statistic methods for certification of reference materials