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JJF 1752-2019 English PDF

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JJF 1752-2019: Calibration Specification for Automatic Closed Luminescence Immunoassay Analyzers
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
JJF 1752-2019349 Add to Cart 3 days Calibration Specification for Automatic Closed Luminescence Immunoassay Analyzers Valid

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Basic data

Standard ID: JJF 1752-2019 (JJF1752-2019)
Description (Translated English): Calibration Specification for Automatic Closed Luminescence Immunoassay Analyzers
Sector / Industry: Metrology & Measurement Industry Standard
Classification of Chinese Standard: A50
Classification of International Standard: 17.020
Word Count Estimation: 15,130
Date of Issue: 2019
Date of Implementation: 2019-12-27
Issuing agency(ies): State Administration for Market Regulation

JJF 1752-2019: Calibration Specification for Automatic Closed Luminescence Immunoassay Analyzers


---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.
Calibration Specification for Automatic Closed Luminescence Immunoassay Analyzers National Measurement Technical Specification of the People's Republic of China Fully automatic closed-type luminescence immunoassay analyzer Calibration specifications 2019-09-27 release 2019-12-27 Implementation Issued by the State Administration of Market Supervision and Administration Fully automatic closed luminescence immunity Analyzer Calibration Specifications Focal point. National Biometrics Technical Committee Main drafting unit. China Academy of Metrology Participated in the drafting unit. Shenzhen Institute of Metrology and Quality Inspection Nanjing Metrology Supervision and Inspection Institute This specification entrusts the National Biometrics Technical Committee to interpret The main drafters of this specification. Wu Liqing (Chinese Academy of Metrology) Jin Youxun (Chinese Academy of Metrology) Participating drafters. Zhifan Huang (Shenzhen Institute of Metrology and Quality Inspection) Hongfei Chen (Nanjing Metrology Supervision and Inspection Institute) Mi Wei (Chinese Academy of Metrology) Zhijian Zhang (Shenzhen Institute of Metrology and Quality Inspection) Xu Sheng (Nanjing Metrology Supervision and Inspection Institute)

table of Contents

Introduction (Ⅱ) 1 Scope (1) 2 References (1) 3 Overview (1) 4 Measurement characteristics (1) 4.1 Indication error (1) 4.2 Repeatability (1) 4.3 Carrying pollution rate (2) 4.4 Linear (2) 5 Calibration conditions (2) 5.1 Environmental conditions (2) 5.2 Calibration reference materials and reagents (2) 6 Calibration items and calibration methods (2) 6.1 Indication error (2) 6.2 Repeatability (2) 6.3 Carrying pollution rate (3) 6.4 Linear (3) 7 Expression of calibration results (3) 8 Recalibration time interval (4) Appendix A Selection Principles of Calibration Standard Materials (5) Appendix B. Contents and Format of Calibration Record and Calibration Certificate (6) Appendix C Examples of Uncertainty Evaluation of Indication Error Measurement Results (9)

Introduction

In the drafting of this specification, reference was made to YY/T 1155-2019 "Automatic Luminescence Immunoassay Analyzer" JJF 1071-2010 "National Metrology Calibration Regulations Writing Rules" requirements. This specification is the first release. Fully automatic closed-type luminescence immunoassay analyzer Calibration specifications

1 Scope

This specification is applicable to the calibration of fully automatic enclosed luminescence immunoanalyzers based on the principles of chemiluminescence and electrochemiluminescence.

2 Reference documents

This specification refers to the following documents. JJF 1001-2011 General Measurement Terms and Definitions JJF 1059.1 Evaluation and expression of measurement uncertainty YY/T 1155-2019 Automatic luminescence immunoassay analyzer For dated reference documents, only the dated version applies to this specification; for those without date references The latest version (including all amendments) is applicable to this specification.

3 Overview

The fully-automatic closed-type luminescence immunoassay analyzer (hereinafter referred to as immunoassay analyzer) is a sample detected by immunoassay Analytical instruments for specific targets in this book. The immune analyzer is usually composed of a computer system, internal servo system, loading unit, The cleaning unit, incubation unit and detection unit are composed (see Figure 1), usually only with the kit kit provided by the manufacturer The completion detection system completes the analysis of specific targets and is closed. The immune analyzer can be completed automatically according to the set procedure The entire analysis process such as sample addition, cleaning, incubation, detection, etc., through the detection of chemiluminescence or electrochemical The luminescence signal realizes the qualitative or quantitative detection of specific targets. Figure 1 Schematic diagram of immune analyzer

4 Metering characteristics

4.1 Indication error According to the measurement result of the reference material specified in 5.2.1, the indication error is not greater than ± 15% Technical requirements given by the supplier. 4.2 Repeatability
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