GB/T 19703-2020 (English Version) PDF

Scope: This standard specifies the requirements for the content of certified reference substances and supporting documents, so that they are considered to have a higher metrological level consistent with GB/T 21415-2008. This standard applies to all kinds of certified reference materials, including primary measurement standards, secondary measurement standards and internationally agreed calibrators used for calibration or correctness control. This standard also provides how to collect data for valuation, and how to express the valuation results and their measurement uncertainty requirements. This standard is applicable to certified reference substances whose assignment results are differential values or proportional values. Appendix A provides information on nominal properties and ordinal quantities. This standard does not apply to reference substances that are part of in vitro diagnostic measurement systems, but many elements may be helpful to it.

GB/T 19703-2020 Referenced Document

GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials
ISO 18153 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
ISO 5725-2 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
ISO/IEC GUIDE 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

2020 GB/T 19703-2020 In vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
2005 GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials