GB/T 19703-2020 in English
VALIDIn vitro diagnostic medical devices—Measurement of quantities in samples of biological origin—Requirements for certified reference materials and the content of supporting documentation
- Issued on:2020-11-19
- Implemented on:2021-12-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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《GB/T 19703-2020体外诊断医疗器械 生物源性样品中量的测量 有证参考物质及支持文件内容的要求》由TC136（全国医用临床检验实验室和体外诊断系统标准化技术委员会）归口，主管部门为国家药品监督管理局。
Introduction
Analysis of the core content of the standard
This standard is equivalent to ISO 15194:2009, which specifies the production, property verification and documentation requirements of certified reference materials (CRMs) in the field of in vitro diagnostics, with the main points including:
Metrology classification system
| Grade type | Definition | Example |
|---|---|---|
| Primary measurement standard | Established through primary reference measurement procedure | Cholesterol solution of known purity |
| Secondary measurement standards | Obtained by calibration with primary standards | NIST human serum lipid CRM |
| Internationally agreed calibrators | Non-SI units but internationally recognized | WHO International Units (IU) |
Key Technical Requirements
1. Interchangeability verification: The measurement consistency of CRM and routine samples must be evaluated, for example, by comparing the results of different measurement procedures to verify the matrix effect of serum protein reference materials.
2. Standards for expressing measurement values: The measurement value must include the numerical value, unit and uncertainty, such as "c=(2.472±0.019)mmol/L (k=2)".
Implementation recommendations
- Document integrity: The certificate must include the 12 core items specified in IEC Guide 31, especially the source of measurement uncertainty
- Stability monitoring: It is recommended to use accelerated aging test (multiple temperature points from -20℃ to 56℃) to verify the 8-10 year validity period
- Minimum sampling volume: The uniformity study should specify the minimum analytical unit (such as 200mg of lyophilized powder)
Standard evolution analysis
Compared with the 2005 version, the main changes in the 2020 version are:
- Added 7 referenced standards such as ISO 5725-2
- Strengthened metrological traceability requirements (corresponding to GB/T 21415)
- Deleted outdated terms such as packaging inserts
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