GB/T 27424-2020
ActiveConformity assessment—Specification for biological quality control materials without metrological traceability
合格评定 非可溯源生物质控品质量控制规范
Application Summary AI generated
This standard specifies the production, characterization, and quality control requirements for biological quality control materials that lack metrological traceability to a reference system. It is applied in clinical laboratories, in vitro diagnostic manufacturers, and proficiency testing providers to ensure the reliability and consistency of non-traceable biological controls used in assays such as immunoassays or molecular tests. The standard supports conformity assessment activities by establishing protocols for homogeneity, stability, and value assignment without requiring a direct link to a higher-order reference standard.
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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
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