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GB/T 27417-2017Conformity assessment—Guidance on validation and verification of chemical analytical methods (English PDF)

合格评定化学分析方法确认和验证指南

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

September 7, 2017

Implementation date

April 1, 2018

Scope

GB/T 27417-2017 is the English-translated version of 合格评定化学分析方法确认和验证指南.

GB/T 27417-2017 gives laboratories general principles for validating and verifying chemical analytical methods.

It states what a validation has to establish and how the characteristic parameters are chosen, then goes through those parameters one by one: selectivity, measuring range, linear range, limit of detection and limit of quantitation, accuracy, precision, robustness and measurement uncertainty.

It also sets the verification requirements, separately for quantitative and for qualitative analysis, and its informative annexes give recovery deviation ranges, laboratory coefficients of variation and a repeatability and reproducibility table.

It applies to non-standard methods, to methods a laboratory develops itself, to standard methods used beyond their intended scope or modified, and to the verification a laboratory carries out before putting a new standard method into use.

It cites ISO/IEC Guide 99:2007. Issued on 7 September 2017, it has applied since 1 April 2018.

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Document preview — GB/T 27417-2017

National Standard of the People's Republic of China

ICS: 03.120.20
Classification: A 00

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Preface
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 method to confirm the request
4.1 General
4.2 Confirmation Method Characteristics Parameter
4.3 confirm the choice of method parameters
5 Confirmation of method characteristic parameters
5.1 Selectivity
5.2 Measuring range
5.3 linear range
5.4 Limit of detection and limit of quantitation
5.5 Accuracy
5.6 Precision
5.7 Robustness
5.8 Measurement uncertainty
6 Method Verification Requirements
6.1 General
6.2 Quantitative Analysis
6.3 Qualitative Analysis
Appendix A (informative) Method recovery rate deviation range
Appendix B (Informative) Laboratory coefficient of variation
Appendix C (Informative) Repeatability and reproducibility table
References

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.

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.

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 document. 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

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 verification

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 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

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

Referenced standards

Normative references

ISO/IEC Guide 99:2007

Cited by

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