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JJF 2036-2023: Calibration Specification for Dry Biochemistry Analyzers
Status: Valid
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Calibration Specification for Dry Biochemistry Analyzers
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JJF 2036-2023
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Standard similar to JJF 2036-2023 JJF 1033 JJF 1050 JJF 1030 Basic data | Standard ID | JJF 2036-2023 (JJF2036-2023) | | Description (Translated English) | Calibration Specification for Dry Biochemistry Analyzers | | Sector / Industry | Metrology & Measurement Industry Standard | | Word Count Estimation | 19,112 | | Date of Issue | 2023-03-15 | | Date of Implementation | 2023-09-15 | | Issuing agency(ies) | State Administration for Market Regulation | JJF 2036-2023: Calibration Specification for Dry Biochemistry 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.
National Metrology Technical Specifications of the People's Republic of China
Calibration specification for dry biochemical analyzer
Released on 2023-03-15
2023-09-15 Implementation
Released by the State Administration for Market Regulation
Responsible Unit: National Biometric Technology Committee
Main drafting unit: Jiangsu Institute of Metrology
Participating in the drafting unit: China Institute of Metrology
Jiangsu Medical Device Inspection Institute
Hunan Institute of Metrology and Testing
This specification entrusts the National Biometric Technology Committee to be responsible for interpretation
The main drafters of this specification:
Cui Hongen (Jiangsu Institute of Metrology)
Chao Zhang (Jiangsu Institute of Metrology)
Zhang Qian (Jiangsu Institute of Metrology)
Participating drafters:
Wu Liqing (National Institute of Metrology)
Yang Zheng (Jiangsu Medical Device Inspection Institute)
Song Jiang (Hunan Institute of Metrology and Testing)
Yi Dazhi (Hunan Institute of Metrology and Testing)
Table of contents
Introduction (Ⅱ)
1 Scope(1)
2 References(1)
3 terms(1)
4 Overview(1)
5 Metrological characteristics(2)
6 Calibration conditions(2)
6:1 Environmental conditions (2)
6:2 Standard materials and reagent samples for calibration (2)
7 Calibration Items and Calibration Methods(3)
7:1 Indication error(3)
7:2 Repeatability(3)
7:3 Linearity(3)
8 Calibration result expression(4)
8:1 Calibration result processing (4)
8:2 Measurement uncertainty of calibration results(4)
9 Recalibration interval(4)
Appendix A Abbreviations (5)
Appendix B Preparation Method of Standard Solution (6)
Appendix C Calibration Raw Record Format(7)
Appendix D Calibration Certificate (Inner Page) Format (9)
Appendix E Evaluation Examples of Measurement Uncertainty (10)
Appendix F References (13)
Introduction
JJF 1071 "Rules for Writing National Metrology Calibration Standards", JJF 1001 "General Metrology Terms and Definitions" and
JJF 1059:1 "Assessment and Expression of Measurement Uncertainty" together constitute the basic series of regulations supporting the formulation of this specification:
Fan: The calibration method and measurement characteristics mainly refer to YY/T 0655-2008 "Dry Chemical Analyzer", CLIA'
88 Analytical Quality Requirements for Proficiency Testing Schemes:
This specification is published for the first time:
Calibration specification for dry biochemical analyzer
1 Scope
This specification applies to the calibration of dry biochemical analyzers based on the quantitative principle of reflectance photometry and differential potential method:
2 References
This specification references the following documents:
YY/T 0655-2008 Dry Chemical Analyzer
For dated references, only the dated version applies to this specification; for undated references,
Its latest edition (including all amendments) applies to this specification:
3 terms
The following terms and definitions defined in YY/T 0655-2008 apply to this specification:
3:1 Dry biochemistry
The liquid sample is placed on the solid phase carrier containing the reagent to undergo a biochemical reaction, and the sample is quantitatively determined according to the reaction result:
method for the concentration or activity of a specific component in a
3:2 End point method
By measuring the total change in product or substrate concentration from the beginning of an enzymatic reaction (chemical reaction) to the time when the reaction reaches equilibrium,
To calculate the enzyme activity (analyte) method:
Note: Also known as balance method, such as the determination of GLU, TB, DB, TP, ALB, TBA, UA, CHO, TG, HDL, etc:
3:3 Differential potential method
Based on the ion-selective electrode principle of traditional wet chemical analysis, the method of obtaining the content of the measured substance is obtained by measuring the relationship between the electrode potential and the ion concentration of the measured substance:
Note: Determination such as K, Na and Cl-, etc:
3:4 Rate method
Refers to the continuous determination (measurement once every 15s~1min) of the concentration of a certain reaction product or substrate in the process of enzymatic reaction:
A method for calculating the rate of an enzymatic reaction as a function of temperature over time:
Note: Also known as continuous monitoring method, such as the determination of ALT, AST, LD, ALP, GGT, AMY and CK:
4 Overview
Dry biochemical analyzer (hereinafter referred to as the analyzer) is an analyzer that uses solid-phase carrier reagents for clinical biochemical testing:
It accurately measures the concentration or activity of specific components in the sample by reflectance photometry, differential potential method and other methods:
Among them, the color reaction of reflectance photometry (including end point method and rate method) occurs on the solid phase carrier, and the transmitted light
Both reflective light and reflected light have obvious scattering effect, do not follow the Lambert-Beer (Lambert-Beer) law, and solid opposite
There are multiple internal reflections between the upper and lower interfaces of the film, using the Kubelka-Munk theory, or by
The Williams-Clapper equation is modified; the differential potential method uses solid-state ion selectivity
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