GB/T 42754-2023 English PDF

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GB/T 42754-2023: General rules for performance evaluation of dry chemistry analyzer
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Basic data

Standard ID: GB/T 42754-2023 (GB/T42754-2023)
Description (Translated English): General rules for performance evaluation of dry chemistry analyzer
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: N53
Classification of International Standard: 71.040.10
Word Count Estimation: 15,180
Date of Issue: 2023-05-23
Date of Implementation: 2023-12-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 42754-2023: General rules for performance evaluation of dry chemistry analyzer

---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.
ICS 71:040:10 CCSN53 National Standards of People's Republic of China General rules for performance evaluation of dry chemical analyzers Released on 2023-05-23 2023-12-01 implementation State Administration for Market Regulation Released by the National Standardization Management Committee

table of contents

Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirements 2 4:1 Working conditions 2 4:2 Appearance 2 4:3 Function 2 4:4 Performance 3 4:5 Data interface 3 4:6 Security 3 4:7 Environmental adaptability 3 4:8 Transport and transport storage 3 5 Evaluation method 3 5:1 Evaluation conditions 3 5:2 Appearance 4 5:3 Functional evaluation 4 5:4 Performance evaluation 4 5:5 Data interface 6 5:6 Safety Inspection 6 5:7 Environmental adaptability 6 5:8 Transport and transport storage 6 6 Evaluation report6 Appendix A (Normative) Performance Evaluation of Supporting Kits 7 A:1 Requirements for performance evaluation of supporting kits 7 A:2 Evaluation method 7 Appendix B (Informative) Instrument Performance Evaluation Report Format Example 10

foreword

This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by China Machinery Industry Federation: This document is under the jurisdiction of the National Industrial Process Measurement Control and Automation Standardization Technical Committee (SAC/TC124): This document was drafted by: Beijing Institute of Food Inspection (Beijing Food Safety Monitoring and Risk Assessment Center), China Inspection and Quarantine Division Science Research Institute, Beijing Hexagon Technology Development Co:, Ltd:, Heilongjiang Provincial Institute of Metrology and Testing, Jilin University, Beijing Saibida Technology Co:, Ltd: Co:, Ltd:, Beijing Qinbang Technology Co:, Ltd:, Guangdong Dayuan Oasis Food Safety Technology Co:, Ltd:, China Quality Certification Center, Chang Chunji Big Little Swan Instrument Co:, Ltd: The main drafters of this document: Jiang Jie, Mao Ting, Zou Mingqiang, Gao Yang, Jia Dongfen, Sun Xiaodong, Ding Haiming, Gao Dejiang, Liu Xingju, Wan Yuping, Fan Jun, Zou Jun, Tian Zhiwei, Wu Xiaosheng, Song Daqian, Dai Feng, Shi Na, Mu Tongna, Luo Xiaoxuan: General rules for performance evaluation of dry chemical analyzers

1 Scope

This document specifies the terms and definitions, requirements, evaluation methods and evaluation reports of dry chemical analyzers: This document is applicable to the performance evaluation of dry chemical analyzers for food testing: This document does not apply to dry chemistry analyzers based on the principle of fluorescence immunoassay:

2 Normative references

The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document: GB/T 3181-2008 Paint film color standard GB 5009:22-2016 National Food Safety Standard Determination of Aflatoxin Group B and Group G in Food GB 5009:33-2016 National Food Safety Standard Determination of Nitrite and Nitrate in Food GB/T 5009:49-2008 Analytical method of hygienic standards for fermented wine and its blended wine GB 5009:275-2016 National Food Safety Standard Determination of Boric Acid in Food GB/T 11606-2007 Environmental test methods for analytical instruments GB/T 12519-2021 General Specifications for Analytical Instruments GB/T 19857-2005 Determination of malachite green and crystal violet residues in aquatic products GB 31658:22-2022 National Food Safety Standard Determination of β-Agonist Residues in Animal Foods Liquid Chromatography- tandem mass spectrometry GB/T 34065-2017 Safety requirements for analytical instruments YY/T 1582-2018 Colloidal gold immunochromatography analyzer GSB05-1426 Paint film color standard sample card

3 Terms and Definitions

The following terms and definitions apply to this document: 3:1 Test card testcard Used in conjunction with dry chemical analyzers, it is a test card or test strip that can be used to identify the tested substance through the color change of the reaction zone: 3:2 dry chemistry analyzer drychemistryanalyzer Based on the principle of colloidal gold immunochromatography or chromogenic method, the analyte in the sample is judged by measuring the reflected signal of the reaction area of the detection card: reading instrument: 3:3 It is an instrument for interpreting the analyte in the sample by measuring the reflected signal of the reaction area of the colloidal gold detection card: by host and supporting reagents ......

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