GB/T 19634-2021 in English
VALIDIn vitro diagnostic test systems—General technical requirements for blood-glucose monitoring systems for self-testing
- Issued on:2021-10-11
- Implemented on:2023-05-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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《GB/T 19634-2021体外诊断检验系统 自测用血糖监测系统通用技术条件》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 revisions to the standard
Compared with the 2005 version, GB/T19634-2021 has mainly made 11 technical revisions, with a focus on strengthening the safety requirements in self-test scenarios:
| Technical Dimensions | Requirements of the 2005 version | Improvements of the 2021 version |
|---|---|---|
| Accuracy Deviation | ±20% | ±15%(≥5.55mmol/L) |
| Hematocrit | Not required | Newly added ±0.55mmol/L deviation limit |
| Electromagnetic compatibility | No requirement | Newly added special requirements of GB/T18268.26 |
Detailed explanation of key performance indicators
1. System accuracy requirements
The new standard adopts segmented deviation control:
- Low concentration range (<5.55mmol/L): absolute deviation ≤±0.83mmol/L
- High concentration range (≥5.55mmol/L): relative deviation ≤±15%
Application case: A certain brand
2. Influence of hematocrit
The standard first establishes the hematocrit-blood glucose concentration matrix test requirements:
| Test dimensions | Technical requirements |
|---|---|
| Hematocrit level | ≥5 gradients |
| Blood glucose concentration | 3 characteristic points (low/medium/high) |
| Allowable deviation | ±0.55mmol/L (low concentration) |
Implementation recommendations
Compliance path for manufacturers
- Establish a three-level calibration system: working calibration product → manufacturer's standing procedure → reference measurement procedure
- Improve electromagnetic compatibility design: must pass the RF immunity test specified in GB/T18268.26
- Optimize test strip batch control: use the Six Sigma method to control the coefficient of variation of film thickness
Precautions for clinical use
- Additional compensation calibration is required in areas with an altitude of ＞2000 meters
- When the hematocrit is <35%, the plasma conversion mode should be used
- The frequency of quality control testing should not be less than once every 24 hours
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