GB/T 21415-2025
ActiveIn vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
体外诊断医疗器械 建立校准品、正确度控制物质和人体样品赋值的计量溯源性要求
Application Summary AI generated
This standard specifies the requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials, and human samples used in in vitro diagnostic (IVD) medical devices. It is applied by manufacturers of IVD products, such as clinical chemistry analyzers and immunoassay systems, to ensure that measurement results are traceable to higher-order reference standards. The standard is critical in laboratory medicine and clinical testing contexts to guarantee the accuracy and comparability of diagnostic results across different laboratories and measurement systems.
Related Standards
GB/T 19634-2005
In vitro diagnostic test systems-General technical requirements for blood-glucose monitoring systems for self-testing
GB/T 47486-2026
General technical requirements for vasculature-on-a-chip
GB/Z 30154-2013
Medical laboratories―Guidance on laboratory implementation of GB/T 22576-2008
GB/Z 16886.22-2022
Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/Z 43281-2023
Guidance for supervisors and operators of point-of-care testing(POCT) devices
GB/Z 43280-2023
Medical laboratories—Practical guidance for the estimation of measurement uncertainty
GB/Z 44363-2024
Pyrogenicity—Principles and methods for pyrogen testing of medical devices
GB/Z 136-2026
Medical laboratories—Reagents for staining biological specimen—Guidance for users
Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.