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

Scope

This standard specifies the requirements for certified reference materials and the content of supporting documents, so that they can be considered to have a high metrological level consistent with GB/T 21415-2008. This standard applies to all types of certified reference materials, including primary measurement standards, secondary measurement standards, and internationally agreed calibration products used for calibration or accuracy control. This standard also provides requirements for how to collect data for assigned values and how to present assigned value results and their measurement uncertainties.
This standard applies to certified reference materials with assigned values in the form of differential values or proportional quantities. Appendix A provides information on nominal characteristics and order quantities.
This standard does not apply to reference materials that are components of in vitro diagnostic measurement systems, but many elements may be helpful to them.

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