Definition of standard, reference, control, and reference materials

Standard substance: Refers to a standard substance used for identification, inspection, and content determination. It is used for content or potency determination in biological assays, antibiotics, or biochemical drugs, and is calibrated using international standards based on potency units or g.

Reference substance: refers to a standard substance used for identification, inspection, and content determination. Unless otherwise specified, it is calculated as a dry substance (or anhydrous substance) and used.

Calibration substance: refers to a calibration substance that has a reference substance used as an independent variable value in the calibration function; It shall have fixed value and known measurement uncertainty, and its purpose shall be to calibrate a measurement system, so as to establish the metrology traceability of the measurement results of this system.

Quality control substance: A quality control substance (fixed value and non fixed value) used for in vitro diagnosis, which is a substance, material, item, or equipment intended for use in medical detection systems. Its purpose is to evaluate or verify performance characteristics such as measurement precision, measurement accuracy, and potential analytical bias caused by changes in reagents or analytical instruments in the detection system. Quality control substances (fixed value and non fixed value) can be used for capability verification and laboratory quality control.

Fixed value quality control products: Fixed value quality control products have reference values that the manufacturer uses appropriate analytical methods or process analysis, and specify a reference range;

Non fixed value quality control products: Non fixed value quality control products can be labeled with target concentrations (such as low, high, and medium) on the label, but there is no specified reference range. It is not necessary to specify the analysis and testing system for the application of non fixed value quality control products, but it must meet the system rules of quality control.

Reference material: Refers to a material or substance that has one or more sufficiently uniform and well-defined characteristics for calibrating measurement devices, rating measurement methods, or assigning values to materials.