SN/T 4562-2016 English PDF

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SN/T 4562-2016: Guidance on measurement uncertainty for GMO testing laboratories
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Basic data

Standard ID: SN/T 4562-2016 (SN/T4562-2016)
Description (Translated English): Guidance on measurement uncertainty for GMO testing laboratories
Sector / Industry: Commodity Inspection Standard (Recommended)
Classification of Chinese Standard: A00
Word Count Estimation: 25,270
Date of Issue: 2016-08-23
Date of Implementation: 2017-03-01
Quoted Standard: ISO 21570-2005
Regulation (derived from): State-Quality-Inspection-Accredidation (2016) No.438
Issuing agency(ies): General Administration of Customs
Summary: This standard specifies the methods, reports and representations of measurement uncertainty assessment in transgenic testing laboratories. This standard applies to the measurement uncertainty assessment of the quantitative detection of event-specific components of a single transgenic line material (such as real-time fluorescent PCR).

SN/T 4562-2016: Guidance on measurement uncertainty for GMO testing laboratories

---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.
Guidance on measurement uncertainty for GMO testing laboratories People's Republic of China entry and exit inspection and quarantine industry standards Guide to measurement uncertainty assessment in transgenic testing laboratories Published on.2016-08-23 2017-03-01 implementation People's Republic The General Administration of Quality Supervision, Inspection and Quarantine issued

Content

Foreword I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 symbols and abbreviations 3 5 Measurement uncertainty assessment 4 5.1 Overview 4 5.2 Evaluation method of measurement uncertainty 5 5.3 General description of the assessment and use of measurement uncertainty 6 5.4 Calculate measurement uncertainty using collaborative experimental data and confirm with internal QC data 7 5.5 Calculate measurement uncertainty with internal QC data 8 5.6 Evaluation of measurement uncertainty 11 5.7 Calculation of critical levels 12 5.8 Calculation of detection limits and quantitation limits 12 5.9 Results Report 13 5.10 Mean uncertainty assessment 14 5.11 How to use measurement uncertainty 14 5.12 Other influencing factors 14 Appendix A (informative) Examples of international collaborative experiments to determine the accuracy of real-time fluorescent PCR methods 16 Appendix B (informative) Example 19 for uncertainty assessment based on single laboratory results Appendix C (informative) Example of data processing that produces uncertainty 22

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard adopts the translation method, which is equivalent to the use of the Institute of Standard Materials and Measurement (IRMM) of the Joint Research Center of the European Commission. EUR22756EN Guide to Measurement Uncertainty in Genetically Modified Laboratories (Guidancedocumentonmeasurementun- certaintyforGMOtestinglaboratories). This standard is compared with EUR22756EN, except for editorial modifications, within the technology. The content is exactly the same, and the text structure is basically the same. This standard is proposed and managed by the National Certification and Accreditation Administration. This standard was drafted. Beijing Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China, Shantou Entry-Exit Inspection and Quarantine Bureau, China National Accreditation Service for Conformity Assessment. The main drafters of this standard. Liang Xinmiao, Cai Ying, Guo Yulei, Li Hong, Rao Hong, Luo Weifeng, Zhou Guangyi, Han Wei, Ma Dan, Xu Wei, Liu Ruosi. Guide to measurement uncertainty assessment in transgenic testing laboratories

1 Scope

This standard specifies the methods, reports and representations of measurement uncertainty assessment in transgenic testing laboratories. This standard applies to the measurement of the process of quantitative detection of event-specific components of a single transgenic line material (such as real-time fluorescent PCR). Uncertainty assessment.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. ISO 21570-2005 Quantitative and qualitative testing of food genetically modified products based on quantitative nucleic acid methods (Foodstuffs-Methods Ofanalysisforthedetectionofgeneticalymodifiedorganismsandderivedproducts-Quantitativenu- Cleicacidbasedmethods) ISO /IEC Guide 98-3.2008 Measurement Uncertainty Part 3. Guide to Measurement Uncertainty [Uncertaintyof measurement-Part 3. Guidetotheexpressionofuncertaintyinmeasurement(GUM.1995)] EU Regulation (EC) No1829/2003 Genetically modified food and feed (European Parliament and of the Council of 22 September2003ongeneticalymodifiedfoodandfeed) European Union Regulation (EC) No 1830/2003 Traceability and identification of genetically modified organisms and traceability of genetically modified organisms in food and feed (EuropeanParliamentandoftheCouncilof22September2003concerningthetraceabilityandlabel- Lingofgeneticalymodifiedorganismsandthetraceabilityoffoodandfeedproductsproducedfromge- NeticalymodifiedorganismsandamendingDirective2001/18/EC)

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Measurement uncertainty measurementuncertainty; MU A parameter that reasonably imparts dispersibility to the value being measured, associated with the measurement. Note 1. This parameter can be such as the standard deviation (or its multiple) or the half width of the confidence interval. Note 2. Measurement uncertainty consists of multiple components. Some of these components can be estimated using the statistical distribution of the measured column results and characterized by experimental standard deviation. another Some components are estimated based on empirical or other information assumed probability distributions, and can also be characterized by standard deviation. Note 3. The measurement results should be understood as the best estimate of the measured value, and all uncertainty components are contributed to the dispersion, including those introduced by system effects. , such as components related to correction values and reference measurement standards. 3.2 Accuracy Consistency of test results and approved reference values. 3.3 Applicability A description of the target, matrix, and concentration to which the method applies. ......

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