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JJF 1823-2020: Calibration Specification for Automatic Urinary Sediment Analyzers
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Calibration Specification for Automatic Urinary Sediment Analyzers
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JJF 1823-2020
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Basic data | Standard ID | JJF 1823-2020 (JJF1823-2020) | | Description (Translated English) | Calibration Specification for Automatic Urinary Sediment Analyzers | | Sector / Industry | Metrology & Measurement Industry Standard | | Classification of Chinese Standard | A61 | | Classification of International Standard | 17.020 | | Word Count Estimation | 13,170 | | Date of Issue | 2020 | | Date of Implementation | 2020-04-17 | | Issuing agency(ies) | State Administration for Market Regulation | JJF 1823-2020: Calibration Specification for Automatic Urinary Sediment 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 Urinary Sediment Analyzers
National Measurement Technical Specification of the People's Republic of China
Calibration specification of automatic urine sediment analyzer
2020-01-17 release
2020-04-17 Implementation
Issued by the State Administration of Market Supervision and Administration
Automatic urine sediment analyzer
Calibration specifications
zers
Focal point. National Biometrics Technical Committee
Main drafting unit. China Academy of Metrology
Participated in the drafting unit. Henan Institute of Metrology
This specification entrusts the National Biometrics Technical Committee to interpret
The main drafters of this specification.
Yingying Liu (Chinese Academy of Metrology)
Wang Jing (Chinese Academy of Metrology)
Participating drafters.
Ding Fengyuan (Henan Institute of Metrology)
Zhang Ling (Chinese Academy of Metrology)
table of Contents
Introduction (Ⅱ)
1 Scope (1)
2 References (1)
3 Terminology (1)
4 Overview (1)
5 Metrological characteristics (1)
6 Calibration conditions (2)
6.1 Environmental conditions (2)
6.2 Reference materials and calibration equipment (2)
7 Calibration items and calibration methods (2)
7.1 Blank value (2)
7.2 Indication error (2)
7.3 Repeatability (3)
7.4 Carrying pollution rate (3)
8 Expression of calibration results (3)
9 Recalibration time interval (3)
Appendix A Calibration Record Format (4)
Appendix B. Internal page format of the calibration certificate (6)
Appendix C Examples of Uncertainty Evaluation of Indication Error of Automatic Urine Sediment Analyzer (7)
Introduction
This specification mainly refers to YY/T 0996-2015 "urinary formed component analyzer (digital imaging automatic recognition
No) '', according to JJF 1071-2010 "Rules for Compiling National Measurement and Calibration Specifications", JJF 1059.1-2012 "Measurement
"Uncertainty Evaluation and Expression" and other standards have been completed. In the process of formulating this specification, reference is also made to the current effective
JJG714-2012 "Blood Cell Analyzer".
This specification is the first release.
Calibration specification of automatic urine sediment analyzer
1 Scope
This specification applies to automatic urine sediment analyzer based on the principle of flow cytometry or automatic identification of microscopic images
Calibration of red blood cell and white blood cell test items, red blood cell and white blood cell of other types of automatic urine sediment analyzer
The test items can be calibrated according to this specification.
2 Reference documents
This specification refers to the following documents.
JJF 1059.1-2012 Evaluation and expression of measurement uncertainty
YY/T 0996-2015 Urine formation analyzer (digital imaging automatic recognition)
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 Terminology
3.1 Urinary sediments urine
The urine samples were precipitated by standard centrifugation, and the formed components observed under the microscope. Including cells, casts, knots
Crystals, bacteria, sperm, and other formed ingredients.
4 Overview
The automatic urine sediment analyzer uses microscopic image automatic identification technology or flow cytometric impedance technology to analyze urine
Inspection equipment for automatic identification and classification counting of the formed elements in the.
Microscopic image automatic identification type urine sediment analyzer uses automatic digital microscope to analyze the urine in the flow counting cell
The samples are scanned, and the collected images are automatically identified by morphology software to obtain various detection data. Flow cytometry
The principle of impedance analysis of urine sediment is. after the cells in the urine are stained with fluorescent pigments, under the action of sheath fluid,
Form a single, vertical column of cell flow, through the argon laser detection area, the instrument detects changes in fluorescence, scattered light and electrical impedance;
When the instrument is capturing fluorescence intensity, forward fluorescence pulse width, forward scattered light intensity, forward scattered light pulse width
After the degree and electrical impedance signals, the size, length, volume and chromatin length of the corresponding cell are comprehensively identified and calculated
Data, and make scattergrams and quantitative reports of red blood cells, white blood cells, bacteria, casts, etc.
5 Metrological characteristics
The measurement characteristics are shown in Table 1.
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