GB/T 19703-2005

Abolished

In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials

体外诊断医疗器械 生物源性样品中量的测量 参考物质的说明

Standard Type
GBT
ICS
11.040
CCS
C30
Status
Abolished
Issue Date
2005-03-23
Implementation
2005-12-01
Centralized Committee
国家药监局
Issuing Authority
中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the requirements for describing reference materials used in the measurement of quantities in biological samples for in vitro diagnostic medical devices. It is applied by manufacturers and laboratories to ensure consistent labeling, characterization, and documentation of reference materials, such as calibrators and control materials, used in clinical chemistry, immunoassays, and other diagnostic testing contexts.

Related Standards

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.