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JJF 2034-2023: Calibration Specification for Microbial Identification and Antimicrobial Susceptibility Testing Systems
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Calibration Specification for Microbial Identification and Antimicrobial Susceptibility Testing Systems
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JJF 2034-2023
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Standard similar to JJF 2034-2023 JJF 1033 JJF 1050 JJF 1030 Basic data | Standard ID | JJF 2034-2023 (JJF2034-2023) | | Description (Translated English) | Calibration Specification for Microbial Identification and Antimicrobial Susceptibility Testing Systems | | Sector / Industry | Metrology & Measurement Industry Standard | | Word Count Estimation | 16,153 | | Date of Issue | 2023-03-15 | | Date of Implementation | 2023-09-15 | | Issuing agency(ies) | State Administration for Market Regulation | JJF 2034-2023: Calibration Specification for Microbial Identification and Antimicrobial Susceptibility Testing Systems
---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
JJF 2034-2023
Calibration specification for microbial identification and drug susceptibility analysis system
Released on 2023-03-15
2023-09-15 Implementation
Released by the State Administration for Market Regulation
Microbial identification and drug susceptibility analysis
System Calibration Specifications
Responsible Unit: National Biometric Technology Committee
Drafting unit: China Institute of Metrology
Jiangsu Institute of Metrology
This specification entrusts the National Biometric Technology Committee to be responsible for interpretation
Drafters of this specification:
Zhang Ling (National Institute of Metrology)
Cui Hongen (Jiangsu Institute of Metrology)
Sui Zhiwei (National Institute of Metrology)
Liu Siyuan (National Institute of Metrology)
Chao Zhang (Jiangsu Institute of Metrology)
Table of contents
Introduction (Ⅱ)
1 Scope(1)
2 References(1)
3 Terms and units of measurement(1)
4 Overview(1)
5 Metrological characteristics(2)
6 Calibration conditions(2)
6:1 Environmental conditions (2)
6:2 Measuring standards and other equipment(2)
7 Calibration Items and Calibration Methods(3)
7:1 Temperature indication error, temperature fluctuation and temperature uniformity (3)
7:2 Illuminance Uniformity and Illuminance Precision of Light Source (3)
7:3 Measurement accuracy(4)
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 Calibration Raw Record Format(5)
Appendix B Calibration Certificate (Inner Page) Format (7)
Appendix C Example of Assessment of Measurement Uncertainty (8)
Appendix D References (10)
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 the selection of measurement characteristics mainly refer to JJF 1101-2019 "Environmental Test Equipment Temperature, Humidity
Specifications for Calibration of Clarity Parameters", JJF 1287-2011 "Calibration Specifications for Clarity Detectors", YY/T 1531-2017 "Detailed
Bacteria Biochemical Identification System", CNAS-GL028 "Guidelines for the Validation of Clinical Microbiological Testing Procedures", CLSIM50-A
This specification is published for the first time:
Calibration specification for microbial identification and drug susceptibility analysis system
1 Scope
This specification is applicable to the identification of bacteria, fungi and other microorganisms and antimicrobial susceptibility tests using optical principles:
The calibration of microbial identification and drug susceptibility analysis systems is not applicable to the calibration of microbial mass spectrometry and nucleic acid sequence identification systems:
2 References
This specification references the following documents:
JJF 1101-2019 Specification for Calibration of Temperature and Humidity Parameters of Environmental Test Equipment
JJF 1287-2011 Calibration specification for clarity detector
YY/T 1531-2017 Bacterial biochemical identification system
CNAS-GL028 Guidelines for Validation of Clinical Microbiological Testing Procedures
For dated references, only the dated version applies to this specification; for undated references
document, its latest version (including all amendments) applies to this specification:
3 Terminology and units of measurement
JJF 1101-2019, JJF 1287-2011, YY/T 1531-2017, CNAS-GL028, CLSIM50-A,
The terms and definitions defined in CLSIM52 and CLSIM100 and below apply to this specification:
3:1 Classification conforms to categoryagreement; CA
Sensitivity, intermediate, dose-dependent susceptibility and resistance between breakpoint assay or minimum inhibitory concentration assay and reference method
consistency of results:
Note: The mathematical expression formula of this concept: NCA·100/N, where: NCA is the category with the reference or comparison method
Number of microbial isolates with the same results in sensitive, intermediate, dose-dependent sensitive and resistant categories;
N is the total number of microbial isolates tested:
[Source: CLSIM52,1:4:2]
4 Overview
Microbial identification and susceptibility analysis system (hereinafter referred to as the analysis system) is a system that can simultaneously test bacteria, fungi and other microorganisms:
It is an instrument for identification and drug susceptibility testing, which uses traditional photoelectric colorimetry and rapid fluorescence
Drug sensitivity test was carried out by photoelectric turbidimetry and fluorescence assay: When the analysis system is working, in a constant temperature incubation loop
Under the environment, the monochromatic light emitted by the optical path scans the analytes on each reagent plate, and the analytes are detected by photoelectric colorimetry and photoelectric turbidimetry:
or fluorescently measure changes in color, turbidity, or fluorescence intensity caused by bacteria decomposing or utilizing substrates, which are read by a reader
The change value of absorbance or fluorescence intensity is converted into an electrical signal, and then analyzed and calculated by the computer according to the strain database and classification conformity:
Calculate the identification results and drug sensitivity results:
The analysis system is divided into semi-automatic analysis system and fully automatic analysis system according to the degree of automation: Analytical systems are usually
It is composed of a bacterial liquid inoculation and sealing device, a photoelectric reader, a constant temperature incubator, a microcomputer and a reagent plate:
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