GB/T 35656-2017 English PDF

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GB/T 35656-2017: Guideline for verification and validation of chemical analysis method and internal quality control -- Method on reporting qualitative test reports
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 35656-2017	519	Add to Cart	5 days	Guideline for verification and validation of chemical analysis method and internal quality control -- Method on reporting qualitative test reports	Valid

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Basic data

Standard ID: GB/T 35656-2017 (GB/T35656-2017)
Description (Translated English): Guideline for verification and validation of chemical analysis method and internal quality control -- Method on reporting qualitative test reports
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: A00
Classification of International Standard: 03.120.10
Word Count Estimation: 26,278
Date of Issue: 2017-12-29
Date of Implementation: 2018-07-01
Regulation (derived from): National Standards Bulletin 2017 No. 32
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 35656-2017: Guideline for verification and validation of chemical analysis method and internal quality control -- Method on reporting qualitative test reports

---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.
Guideline for verification and validation of chemical analysis method and internal quality control - Method on reporting qualitative test reports ICS 03.120.10 A00 National Standards of People's Republic of China Chemical analysis method validation validation and internal quality control A guideline to guide the reporting of qualitative results 2017-12-29 Posted 2018-07-01 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 General 2 4.1 Chemical Analysis Method Classification 2 4.2 Report qualitative characteristics of the method 2 4.3 Report Qualitative Results Method Verification Confirmation Requirements 2 4.4 limit test 2 4.5 Qualitative and broad-spectrum screening methods 3 4.6 preparation of standard operating procedures 3 5 pairs of method performance verification and validation requirements 3 5.1 Sensitivity 3 5.2 Selectivity and specificity 3 5.3 Threshold 4 5.4 false negative rate and false positive rate 4 5.5 Detection limit 5 6 Internal Quality Control 5 Appendix A (informative) method of threshold calculation example 6 Appendix B (Informative) Sensitivity-specific performance indicators confirm Example 10 Appendix C (informative) Examples of interference tests and interference cancellation 16 Appendix D (informative) method threshold determination example 21 Appendix E (informative) t test threshold Table 22 References 23

Foreword

This standard constitutes the following chemical laboratory analysis and verification methods to confirm the establishment and implementation of internal quality control system series standard. --- GB/T 32464 chemical analysis laboratory internal quality control control chart verification analysis system; --- GB/T 32465 chemical analysis validation verification and internal quality control requirements; --- GB/T 32467 chemical analysis method validation validation and internal quality control terms and definitions; --- GB/T 33464 chemical analysis standard operating procedures for the preparation and use of guidelines; --- GB/T 35655 chemical analysis methods validation verification and internal quality control implementation guidelines chromatography; --- GB/T 35657 Chemical analysis methods validation verification and internal quality control implementation guidelines Based on sample digestion of metal components analysis. This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard by the National Quality Supervision Key Products Testing Methods Standardization Technical Committee (SAC/TC374) and focal point. This standard was drafted unit. Sichuan Provincial Institute of Quality Supervision, Inspection and Quarantine, the quality inspection center Warner (Beijing) Co., Ltd., Sichuan Institute of Technology, China Federation of Inspection (Beijing) Quality Inspection Technology Co., Ltd., Sichuan Food and Drug Inspection and Testing Institute, Anhui Province Product Quality Supervision Inspection Inspection Institute, Beijing Yingtai Jia and Analytical Technology Co., Ltd., Chengdu Hongyi Industrial Group Co., Ltd. The main drafters of this standard. Zheng Weidong, Zhang Liping, Hu Dan, Fu Dayou, Tan Wenyuan, Huang Ying, Yu Xiaoqin, Lin Sen, Fan Zhigang, Wang Junfang, Lin Jibai, Ding Yuanli, Lin Hong, Wang Yue.

Introduction

The detection of qualitative results reported is an important form of analysis in chemical analysis characterized by the qualitative detection of test results Tell The expression of qualitative results is divided into two cases. First, the direct use of qualitative detection methods, draw and report qualitative results; the second is to use Quantitative method detection, continuous quantitative results obtained, the use of specific methods will be quantitative results into qualitative results, and finally report the qualitative knot fruit. Binary classification test is a special case of quantitative analysis and qualitative analysis, presence/absence test or Positive/negative test (positive/negativetest) is a binary classification test of two typical cases. Limit test (limittest) and qualitative QualitativeBroadband (non-targeted) analytescreening is the use of two binary classification test technology A typical method of reporting qualitative results. Laboratory to correctly grasp and use the qualitative results of the method of expression, in addition to the provisions of GB/T 32465-2015, the implementation of the method test In addition to confirming and establishing an internal quality control system, attention should also be paid to the particularities of such methods in detecting and reporting the results. Chemical analysis method validation validation and internal quality control A guideline to guide the reporting of qualitative results

1 Scope

This standard gives the chemical analysis of qualitative results reported in the verification method validation and laboratory internal quality control requirements and implementation guidelines. This standard applies to the chemical analysis of qualitative results reported in the validation test and laboratory internal quality control. This standard does not apply to sampling.

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. GB/T 6379.1 accuracy and accuracy of measurement methods (accuracy and precision) Part 1. General and definitions GB/T 14666 analytical chemistry terminology GB/T 19000 quality management system foundation and terminology GB/T 27025-2008 General requirements for the competence of testing and calibration laboratories Chemical analysis methods validation verification and internal quality control requirements GB/T 32465-2015 GB/T 32467 chemical analysis methods validation validation and internal quality control terms and definitions GB/T 33464 chemical analysis standard operating procedures and guidelines for the preparation and use ISO 11843-1 detection capabilities Part 1. Terms and definitions (Capabilityofdetection-Part 1.Termsanddefi- nitions

3 Terms and definitions

GB/T 6379.1, GB/T 14666, GB/T 19000, GB/T 32467 and ISO 11843-1 as defined by the following terms and definitions Meaning applies to this document. 3.1 Positive predictive value positivepredictivevalues; PPV The ratio of true positives to total positives was determined. Note. The total positive results include the sum of the true positives and the false positives. Positive predictive value = true positive result/(true positive result false positive result). 3.2 Negativepredictivevalues; NPV The ratio of true negative results to total negative results was determined. Note. The total negative results include the sum of true negative and false negative results. Negative predictive value = true negative result/(true negative result false negative result). 3.3 Qualitative broad-spectrum screening qualitativebroad-band (non-targeted) analytescreening Using a specific method, multiple target components are detected at the same time, and the result is compared with the reference data to obtain a "yes" or "no" target group Points of conclusion. ......

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