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GB/T 35657-2017 English PDF

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GB/T 35657-2017: Guideline for verification and validation of chemical analysis method and internal quality control -- Metal component analysis based on sample digestion
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PDF similar to GB/T 35657-2017


Standard similar to GB/T 35657-2017

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Basic data

Standard ID GB/T 35657-2017 (GB/T35657-2017)
Description (Translated English) Guideline for verification and validation of chemical analysis method and internal quality control -- Metal component analysis based on sample digestion
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard A00
Classification of International Standard 03.120.10
Word Count Estimation 70,782
Date of Issue 2017-12-29
Date of Implementation 2018-07-01
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 35657-2017: Guideline for verification and validation of chemical analysis method and internal quality control -- Metal component analysis based on sample digestion


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Guideline for verification and validation of chemical analysis method and internal quality control-Metal component analysis based on sample digestion ICS 03.120.10 A00 National Standards of People's Republic of China Chemical Analysis Method Verification Confirmation and Internal Quality Control Implementation Guide Analysis of Metal Fractions Based on Sample Digestion Published on.2017-12-29 2018-07-01 Implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Administration released Directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 2 4 General 2 5 Method Validation and Validation Technique 2 5.1 Analysis System Adaptability 2 5.2 Selectivity 3 5.3 Stability 3 5.4 Durability 5 5.5 Linearity and Calibration 5 5.6 Recovery rate 7 5.7 Limits of Detection and Limits of Quantification 7 5.8 Detection Capability 8 5.9 Accuracy 8 5.10 Repeatability 8 5.11 Reproducibility 9 5.12 Uncertainty of measurement 9 6 Inspection Process Quality Control 9 6.1 General 9 6.2 Calibration Curve Quality Evaluation and Inspection 9 7 Analysis System Verification 10 7.1 General 10 7.2 Participate in proficiency testing or measurement audit plan 10 7.3 Inter-laboratory comparison 10 7.4 Using Control Chart Verification and Analysis System 11 Appendix A (Informative) Example of Interlaboratory Comparison of Organizations to Determine the Reliability of Laboratory Methods 13 Appendix B (Informative) Example of Inspection Method Stability 19 Appendix C (Informative) Durability Test Example 25 Appendix D (Informative) Linear and Calibration Confirmation Example 29 Appendix E (informative annex) Confirmation of recovery rate 35 Appendix F (Informative) Confirmation Limits and Limits of Quantification Confirmation 40 Appendix G (Informative) Methodological Test Example Calculation Example 44 Appendix H (informative annex) Examples of laboratory bias and precision evaluation 55 Appendix I (Informative) Evaluation Examples of Measurement Uncertainty 58 Appendix J (Informative) Critical Table of Statistical Analysis 66 Reference 67

Foreword

This standard and the following standards constitute the validation, validation and establishment and implementation of internal quality control systems for chemical analysis laboratory testing methods. Column criteria. --- GB/T 32464 Chemical analysis laboratory internal quality control use control chart verification analysis system; --- GB/T 32465 Chemical Analysis Method Verification Confirmation and Internal Quality Control Requirements; --- GB/T 32467 Chemical Analysis Method Verification Validation and Internal Quality Control Terms and Definitions; ---GB/T 33464 Guidelines for the preparation and use of standard operating procedures for chemical analysis; --- GB/T 35655 Chemical Analysis Method Validation Confirmation and Internal Quality Control Implementation Guidelines Chromatographic Analysis; --- GB/T 35656 Methods for validation of chemical analysis methods and guidelines for the implementation of internal quality control Methods for reporting qualitative results. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and managed by the National Standardization Technical Committee for Quality Inspection Key Product Inspection Methods (SAC/TC374). This standard was drafted by. Sichuan Province Product Quality Supervision, Inspection and Testing Institute, Zhonghua Warner (Beijing) Quality Technology Center Co., Ltd., China Inspection Alliance (Beijing) Quality Inspection Technology Research Institute Co., Ltd., Sichuan Food and Drug Inspection and Testing Institute, Sichuan Institute of Technology, Chengdu Hongyi Industrial Group Limited company. The main drafters of this standard. Zheng Weidong, Hu Dan, Huang Hao, Yu Xiaoqin, Zhang Liping, Fu Dayou, Tan Wenyuan, Fan Zhigang, Wang Junfang, Lin Hong. Chemical Analysis Method Verification Confirmation and Internal Quality Control Implementation Guide Analysis of Metal Fractions Based on Sample Digestion

1 Scope

This standard gives sample-based digestion using atomic absorption spectrometry (AAS), atoms Atomic fluorescence spectrometry (AFS), inductively coupled plasma atomic emission spectrometry (inductively co Pledplasmaatomicemissionspectrometry, ICP-AES, inductively coupled plasma mass spectrometry (inductivelycoupled) Plasmamassspectrometry, ICP-MS) Method for verification of metal components in four testing areas Validation Confirmation and establishment Internal quality of implementation Guidelines for the control system. This standard applies to atomic absorption spectrometry, atomic fluorescence spectrometry, inductively coupled plasma emission spectrometry, inductively coupled plasmas Methods such as mass spectrometry based on the analysis of metal components in sample digestion confirm the establishment and implementation of an internal quality control system. This standard deals only with quantitative analysis methods and does not include sampling. For laboratories that use other spectral analysis methods to analyze metal components, refer to the contents of this standard.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 3358.1 Statistical terms and symbols - Part 1. General statistical terms and terms used for probabilistic GB/T 3358.2 Statistical terms and symbols - Part 2. Application statistics GB/T 3358.3 Statistical terms and symbols - Part 3. Experimental design GB/T 6379.1 Accuracy (correctness and precision) of measurement methods and results Part 1. General rules and definitions GB/T 10092-2009 Statistical analysis of data and interpretation of multiple comparisons of test results GB/T 14666 Analytical Chemistry Terms GB/T 15000.2 Working Guide for Standard Samples (2) Common Terms and Definitions for Standard Samples GB/T 15000.3 Working guide for standard samples (2) General principles and statistical methods for setting standard samples GB 17378.2-2007 Marine Monitoring Code Part 2. Data Processing and Analysis Quality Control GB/T 19000 Quality Management System Foundation and Terminology GB/T 22554 Linear Calibration Based on Standard Samples GB/T 27407 Laboratory Quality Control Utilization Statistical Quality Assurance and Control Chart Technology GB/T 32464-2015 Chemical Analysis Laboratory Internal Quality Control Utilization Control Chart Verification Analysis System GB/T 32465-2015 verification of chemical analysis methods and internal quality control requirements GB/T 32467 Chemical Analysis Method Verification Verification and Internal Quality Control Terms and Definitions GB/T 33464 Guidelines for the preparation and use of standard operating procedures for chemical analysis SN1482 Laboratory Internal Quality Control Method MR Statistics and Dynamic Tracking Monitoring Technology ISO 11843-1 Test Capability Part 1. Terms and Definitions (Capability of detection-Part 1. Termsanddef- Initions) ISO 11843-2 Detection Capability Part 2. Linearity Correction Method (Capability of detection-Part 2. Methodology Inthelinearcalibrationcase)

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