GB/T 27417-2017 English PDF

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GB/T 27417-2017: Conformity assessment -- Guidance on validation and verification of chemical analytical methods
Status: Valid

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Basic data

Standard ID: GB/T 27417-2017 (GB/T27417-2017)
Description (Translated English): Conformity assessment -- Guidance on validation and verification of chemical analytical methods
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A00
Word Count Estimation: 19,127
Date of Issue: 2017-09-07
Date of Implementation: 2018-04-01
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

GB/T 27417-2017: Conformity assessment -- Guidance on validation and verification of chemical analytical methods

---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.
Comformity assessment - Guidance on validation and verification of chemical analytical methods ICS 03.120.20 A00 National Standards of People's Republic of China Conformity assessment methods for the confirmation and verification of chemical analysis methods 2017-09-07 Posted 2018-04-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China China National Standardization Administration released Directory Preface Ⅰ Introduction Ⅱ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 method to confirm the request 4 4.1 General 4 4.2 Confirmation Method Characteristics Parameter 4 4.3 confirm the choice of method parameters 4 5 Confirmation of method characteristic parameters 5 5.1 Selectivity 5 5.2 Measuring range 6 5.3 linear range 6 5.4 Limit of detection and limit of quantitation 6 5.5 Accuracy 8 5.6 Precision 9 5.7 Robustness 10 5.8 Measurement uncertainty 10 6 Method Verification Requirements 10 6.1 General 10 6.2 Quantitative Analysis 6.3 Qualitative Analysis 11 Appendix A (informative) Method recovery rate deviation range 12 Appendix B (Informative) Laboratory coefficient of variation 13 Appendix C (Informative) Repeatability and reproducibility table 14 References 15

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard was approved by the National Accreditation Committee for Standardization Technical Committee laboratory accreditation sub-technical committee (SAC/TC261/SC1) proposed Focused. This standard drafting unit. China National Accreditation Service for Conformity Assessment, Exit Inspection and Quarantine of Zhejiang Province, Shanghai Measurement and Testing Technology Research Institute. The drafters of this standard. Zhang Mingxia, Yang Yaowu, Huojiang Lian, Wang Yaning, Bao Xiaoxia, Pan Han Shun, Mou Dehai, Chen Sheng, Chu Qinghua, Dai Qi, Guo Wenping.

Introduction

With the progress of science and technology and the development of international trade, the quality of laboratory chemical analysis methods and testing data A higher requirement. At present, some foreign countries have released some confirmation rules about the chemical analysis methods, but our country has not released the chemical points Analysis of laboratory methods to confirm and verify the standard or guideline in the actual laboratory testing, often encountered in the current testing standards Unable to cope with the rapid development of detection methods. In order to provide more accurate and efficient testing services, laboratories often need to adopt Self-developed or improved detection methods, especially in the area of chemical analysis, more and more laboratories use standards other than detection methods, but How to ensure the suitability and reliability of these detection methods has been controversial. In addition, the laboratory according to the different needs of customers, need to choose New standard methods, how laboratories demonstrate the technical capabilities of new standard test methods, the accuracy and reliability of test results, and There is no uniform approach. This standard is the laboratory chemical analysis methods to confirm the methodological and methodological guidance document to improve the laboratory chemistry Analyze methods and quality of test data to ensure that the data provided by chemical analysis laboratories are valid, fair and reliable. Conformity assessment methods for the confirmation and verification of chemical analysis methods

1 Scope

This standard gives the laboratory chemical analysis methods to confirm the methods and methods to verify the general principles. This standard applies to non-standard laboratory methods, laboratory methods developed beyond its intended scope of use of standard methods to expand and Method validation of modified standard methods, and laboratory validation of methodologies prior to the official introduction of the new standard method.

2 Normative references

The following documents for the application of this document is essential. 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 /IEC Guide 99.2007 International metrology vocabulary - basic and generic concepts and related terms [Internationalvocabulary of metrology-Basic and general criteria and associated devices (VIM)]

3 Terms and definitions

ISO /IEC Guide 99.2007 defined and the following terms and definitions apply to this document. For ease of use, the following list is repeated Some terms and definitions in ISO /IEC Guide 99.2007. Note. This standard is mainly applicable to laboratories, according to the principles of ISO /IEC 17025, when the same terms have different definitions, give priority to use ISO /IEC Guide 99.2007 definition. 3.1 Method validation methodvalidation Laboratory tests to provide objective and valid evidence that a particular test method to meet the intended use. Notes 1. Method Validation It is advisable to establish the performance characteristics and limitations of the method used, identify the factors that influence the performance of the method and the extent of the effects, and determine the appropriate method The matrix used, as well as the correctness and precision of the method. Note 2. Adapted from ISO /IEC Guide 99.2007, Definition 2.45. 3.2 Method validation methodverification Laboratory verification, to provide objective and valid evidence to meet the requirements of test methods. Note. Adapted from ISO /IEC Guide 99.2007, Definition 2.44. 3.3 In-house method validation in-housemethodvalidation In a laboratory, within a reasonable time interval, using a method under the predetermined conditions for the same or different sample analysis Test to prove that the specific test method to meet the intended use. 3.4 Interlaboratory method validation interlaboratorymethodvalidation Method validation between two or more laboratories. Laboratory in accordance with the predetermined conditions in the same method for the same sample determination, To prove that the specific test method to meet the intended use. ......

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