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JJF 1720-2018 English PDF

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JJF 1720-2018: Calibration Specification for Automatic Chemistry Analyzers
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Basic data

Standard ID JJF 1720-2018 (JJF1720-2018)
Description (Translated English) Calibration Specification for Automatic Chemistry Analyzers
Sector / Industry Metrology & Measurement Industry Standard
Classification of Chinese Standard A61
Word Count Estimation 18,136
Date of Issue 2018-12-25
Date of Implementation 2019-03-25
Regulation (derived from) State Administration of Markets, Announcement No.34 of 2018
Issuing agency(ies) State Administration for Market Regulation

JJF 1720-2018: Calibration Specification for Automatic Chemistry 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 Chemistry Analyzers National Metrology Technical Specification of the People's Republic Automatic biochemical analyzer calibration specification Published on.2018-12-25 2019-03-25 implementation State Market Supervisory Administration released Automatic biochemical analyzer calibration specification Focal Point. National Medical Metrology Technical Committee Drafting unit. China Institute of Metrology Hitachi Diagnostics Products (Shanghai) Co., Ltd. Shenzhen Mindray Biomedical Electronics Co., Ltd. This Code entrusts the National Medical Metrology Technical Committee to explain Drafters of this specification. Xie Baomin (China Institute of Metrology) Wu Liqing (China Institute of Metrology) Cheng Qing (Hitachi Diagnostics Products (Shanghai) Co., Ltd.) Xie Chuanfen (Shenzhen Mindray Biomedical Electronics Co., Ltd.)

table of Contents

Introduction (II) 1 Scope (1) 2 References (1) 3 Terms and units of measurement (1) 3.1 Automatic Biochemical Analyzer (1) 3.2 Absorbance (1) 4 Overview (1) 5 Measurement characteristics (2) 5.1 Absorbance indication error (2) 5.2 Absorbance repeatability (2) 5.3 Linearity error (2) 5.4 ALT and GLU measurement indication error and repeatability (2) 6 Calibration conditions (3) 6.1 Environmental conditions (3) 6.2 Reference materials (3) 7 Calibration items and calibration methods (3) 7.1 Appearance (3) 7.2 Absorbance indication error (3) 7.3 Absorbance repeatability (3) 7.4 Linearity error (4) 7.5 ALT and GLU measurement indication error (4) 7.6 ALT and GLU measurement repeatability (4) 8 Calibration result expression (4) 9 re-study interval (5) Appendix A Calibration Original Record (Recommended) Format (6) Appendix B Calibration Certificate Inner Page (Recommended) Format (8) Appendix C Example of Evaluation of Uncertainty of Absorbance Indication Error Calibration (10)

Introduction

This specification is based on JJF 1001-2011 "General Terms and Definitions of Measurement", JJF 1071-2010 "National Measurement Rules for the preparation of calibration specifications, JJG464-2011 "Semi-automatic biochemical analyzer" and YY/T 0654-2017 Automatic biochemical analyzer prepared in accordance with international recommendations OIMLR135.2004 (E) "Medical laboratory spectrum Based on Spectrophotometersformedicallaboratories, combined with biochemical analyzers in China Using the status quo of development and the characteristics of automatic biochemical analyzer, this specification is applicable to automatic biochemical analyzers. calibration. This specification is the first release. Automatic biochemical analyzer calibration specification

1 Scope

This specification applies to the calibration of fully automated biochemical analyzers based on Lambert-Beer's law as a quantitative principle. Calibration of dry biochemical analyzers using the spectrophotometric method as a quantitative principle.

2 reference files

JJG464-2011 Semi-automatic biochemical analyzer JJF 1071-2010 National Metrology Calibration Specification Writing Rules JJF 1059.1-2012 Measurement uncertainty evaluation and representation YY/T 0654-2017 automatic biochemical analyzer OIMLR135.2004 (E) Spectrometer for medical laboratory (Spectrophotometersformedicalla- Boratories) For dated references, only dated versions apply to this specification; undated quotations The latest version (including all amendments) applies to this specification.

3 terms and units of measure

The following terms and definitions apply to this specification. 3.1 automatic biochemical analyzer automaticchemistryanalyzer All analytical procedures (including filling of samples and reagents, mutual reactions, chemical and biological analysis, calculation of results, and The results were read out) automated biochemical analyzers were implemented. [YY/T 0654-20173.2] 3.2 absorbance absorbance The ratio of the transmitted light intensity to the incident light intensity is the transmittance, and the common logarithm of the reciprocal of the transmittance is called the absorbance. [YY/T 0654-20173.1]

4 Overview

The automatic biochemical analyzer (hereinafter referred to as the analyzer) is based on the characteristics of the measured substance in the ultraviolet and visible regions. The absorption spectrum follows the principle of Lange-Beer law and compares samples of unknown concentration to known concentrations of reference materials. Quantitative analysis is performed or according to the molar absorption coefficient method. The expression of Lange-Beer's law is as follows. A=-lg(I/I0)=-lgT=klc (1) In the formula. A---the absorbance of the substance; I0---incident light intensity; I---transmitted light intensity; T---the transmittance of the substance; k---the molar absorption coefficient of the substance, L·mol-1·cm-1;

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