SN/T 5295-2021 in English
VALIDGuidelines for basic statistics in chemical analysis laboratories
- Issued on:2021-11-22
- Implemented on:2022-06-01
- File Format:PDF
- Delivery:Via email within 5 business days
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Introduction
Analysis of the core content of the standard
This standard systematically regulates the statistical processing methods of measurement data in chemical analysis laboratories, including 6 major technical modules: basic statistical methods, orthogonal experimental design, method validation, quality control, appendix cases and statistical tables. It is suitable for method development, validation and daily quality control.
Key Technical Points
| Statistical Methods | Application Scenarios | Judgment Criteria |
|---|---|---|
| Grubbs Test | Outlier Detection for Single Group Data | α=0.05/0.01 Critical Value |
| Cochran Test | Multi-group Variance Consistency Test | C value>critical value to determine outliers |
| Orthogonal Experiment Variance Analysis | Multi-factor Optimization Experiment | F value>Fcritical is significant |
Key indicators of method verification
Precision verification
Calculated by repeatability standard deviation (sr) and reproducibility standard deviation (sR):
sR = √(sL2 + sr2)
The example shows that the lead content of PVC plastic is sr=3.10mg/kg and sR=7.27mg/kg (Appendix C)
Accuracy verification
Using t-test or critical difference (CD value):
CD = √[2.8(sR2 - sr2(1-1/n))]
In the DBP detection case, |bias|=46mg/kg<CD value 366mg/kg (Appendix D)
Implementation suggestions
- Data preprocessing: Normality test (GB/T 4883) and outlier elimination must be performed
- Method development stage: Orthogonal test method (L9(34)) is preferred to optimize parameters
- Quality control chart update: Control limits can be established only after accumulating ≥20 sets of valid data
- Matrix Effect Assessment: Determining Inhibition/Sensitization Effects by Slope Difference Test (F/t Test)
Comparison of Standard Evolution
| Version | New Content | Technological Breakthrough |
|---|---|---|
| 2021 Edition | Orthogonal Experiment Design Chapter | Introduction of Combination of Range Analysis and Variance Analysis |
| Historical Versions | Basic Statistical Methods | Only t-test/F-test |

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