GB/T 19702-2021 in English
VALIDIn vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures
- Issued on:2021-03-09
- Implemented on:2022-04-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
$340.00
《GB/T 19702-2021体外诊断医疗器械 生物源性样品中量的测量 参考测量程序的表述和内容的要求》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
Interpretation of the core content of the standard
GB/T19702-2021, as an important standard in the field of in vitro diagnostic medical devices, is equivalent to the ISO15193:2009 international standard, and puts forward systematic requirements for the reference measurement procedures for quantity measurements in biological samples. This standard applies to reference measurement procedures that provide differential values or proportional values. Its technical highlights are reflected in:
| Core elements | 2005 version | Main changes in the 2021 version |
|---|---|---|
| Definition of terms | Basic terminology system | Six new terms such as analytical sensitivity and detection limit |
| Element classification | 18 basic elements | Adjustment of 4 element attributes (such as quality assurance changed to essential elements) |
| Technical requirements | Basic measurement requirements | Strengthen 9 performance indicators such as intermediate precision standard deviation |
Key elements of reference measurement procedures
1. Procedure structure requirements
The standard stipulates that the reference measurement procedure must contain 20 structured elements, of which 12 items such as warnings, measurement principles, and analytical reliability are essential elements.
- Preprocessing stage: sample collection/processing specifications (Clause 4.10)
- Core operations: measurement system preparation (4.11), instrument operation (4.12)
- Quality control: data processing (4.13), confirmation procedures (4.16)
2. Metrological traceability requirements
The standard places special emphasis on establishing a complete metrological traceability chain:
- Certified reference materials that comply with ISO15194 must be used
- The calibrator must meet the requirements of ISO17511/ISO18153
- The measurement uncertainty assessment follows ISO/IEC Guide 98-3
Implementation points and suggestions
Laboratory Application Recommendations
According to Clause 4.18 of the standard, the laboratory should establish a three-level quality assurance system:
| Level | Control Measures | Frequency Requirements |
|---|---|---|
| Primary | Instrument Performance Verification | Daily/Batch |
| Intermediate | In-house Quality Control Product Testing | ≥1 time/analysis batch |
| Advanced | Inter-laboratory Comparison | ≥2 times/year |
Special Considerations
In view of the particularity of biological samples, clause 4.10.2 of the standard specifically requires:
- Specify the material of the sample container (such as light-proof vacuum blood collection tubes)
- Record the transportation conditions (temperature, time, vibration) in detail
- Establish a sample stability verification procedure (limit on the number of freeze-thaw cycles, etc.)
Technology Evolution Analysis
Compared with the 2005 version, the 2021 version of the standard mainly reflects three major technological upgrades:
- Improvement of the conceptual system: Introduce VIM3 metrology terminology to clarify the difference between measured quantity and analyte
- Strengthening of process control: Add performance indicator requirements such as intermediate precision standard deviation (4.14.13)
- International integration: fully aligned with ISO15193:2009 technical requirements, facilitating the export of domestic IVD products
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