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GB/T 27415-2013: Estimate of detection and quantitation limit for analytical method
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 27415-2013 | English | 419 |
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Estimate of detection and quantitation limit for analytical method
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GB/T 27415-2013
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Basic data | Standard ID | GB/T 27415-2013 (GB/T27415-2013) | | Description (Translated English) | Estimate of detection and quantitation limit for analytical method | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | B04 | | Classification of International Standard | 19.02 | | Word Count Estimation | 18,134 | | Quoted Standard | GB/T 3359; GB/T 22554; GB/T 27407; JJF 1001 | | Regulation (derived from) | National Standards Bulletin 2013 No. 17 | | Issuing agency(ies) | General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China | | Summary | This standard specifies: the detection limit and the relative standard deviation (RSD) when Z% the limit of quantification assessment procedures. This standard applies to: Ignore the laboratory calibration error situations sometimes lab the detection limi | GB/T 27415-2013: Estimate of detection and quantitation limit for analytical method---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Estimate of detection and quantitation limit for analytical method
ICS 19.02
B04
National Standards of People's Republic of China
Analysis method detection limit and quantitation limit of assessment
Issued on. 2013-09-06
2013-12-01 implementation
Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China
Standardization Administration of China released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard certification and accreditation by the National Standardization Technical Committee (SAC/TC261) and focal points.
This standard was drafted. Liaoning Entry-Exit Inspection and Quarantine, Shandong, Beijing University of Technology, China National Conformity Assessment
AIs Center, Chinese Center for Disease Control and Prevention, Dehong Integrated Quality and Technical Supervision and Testing Center, Guangdong CIQ, Shanxi
Entry-Exit Inspection and Quarantine Shanghai, China Institute of Metrology, national hazardous chemicals Quality Supervision and Inspection Center,
National Electrical Safety Quality Supervision and Inspection Center.
The main drafters of this standard. Wang Wen bucket, Chen Shan, Xie law, cattle Xingrong, Sun Hairong, Yang Jiaolan, Shichang Yan, Yun Deng, Zhong Zhiguang, fat Zhao Bao,
Chen Jun water, Jing, Xing right, Wang Ji Tao, Wang Ni.
Introduction
The standard assessment procedure is a "mathematical model method", which is different from the widespread use of "single-point calibration method."
"Single-point calibration method" and the "mathematical model method" is the primary means of detection and quantitation limits assessment, the difference between the two is as follows.
a) standard differential treatment
--- "Single-point calibration method" as the difference between the standards is a constant;
--- "Mathematical model method" that changes with the concentration difference between the standard and multi-point fit the experimental data.
b) two types of error rate (α and β) control
--- "Single-point calibration method" gives only the level of α;
--- "Mathematical Model Law" taking into account the level of α and β.
c) fitting method
--- "Single-point calibration method" using ordinary least squares fitting (OLS);
--- "Mathematical Model Law" weighted least squares fitting (WLS).
d) model checking
--- "Single-point calibration method" model not fit statistical test;
--- "Mathematical Model Law" fit of the model significance test.
e) bias correction
--- "Single-point calibration method" does not consider bias correction;
--- "Mathematical Model Law" to establish bias correction regression model.
f) intervals were calculated
--- "Single-point calibration method" as "confidence interval" calculated;
--- "Mathematical Model Law" by "statistical tolerance interval" calculations.
g) define the scope
--- "Single-point calibration method" only for laboratory research;
--- "Mathematical Model Law" applies to both the laboratory, but also for laboratory research.
Analysis method detection limit and quantitation limit of assessment
1 Scope
This standard specifies the limit of detection and limit of quantification assessment procedures relative standard deviation (RSD) of Z% of the time.
This standard applies to ignore the calibration error condition detection and quantitation limits laboratories or between the laboratory assessment.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
Statistical processing and interpretation of statistical tolerance intervals of GB/T 3359 data to determine
GB/T 22554 linear calibration based on a standard sample
GB/T 27407 laboratory quality control use performance statistics for quality assurance and control chart technical evaluation and analysis of the measurement system
JJF1001 common measurement terms and definitions
3 Terms and Definitions
GB/T 3359 and JJF1001 defined in the following terms and definitions, symbols apply to this document.
3.1
Laboratory detection limit InterlaboratoryDetectionEstimate
IDE
The minimum concentration can be detected with high probability, i.e., at 90% confidence level, the ratio of the concentration of the sample is detected by the IDE Laboratory
95%, the proportion of the sample concentration is 0 is not detected in laboratory was 99%.
3.2
Interlaboratory limit of quantification InterlaboratoryQuantitationEstimate
IQE
RSD is equal to Z% minimum concentration corresponding.
3.3
Interlaboratory Pro boundaries InterlaboratoryCriticalLimit
ICL
At 90% confidence level, the ratio of the concentration of the sample is not detected correctly 0 laboratory was 99%.
3.4
Experimental standard deviation experimentalstandarddeviation
Standard deviation standarddeviation
The same is measured n times measurement, characterization measurements of the amount of dispersion.
Note 1. n measurements of a single measured value xk experimental standard deviation s (xk) according to Bessel formula.
s (xk) =
i = 1
(Xi-x) 2
n-1
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