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YY/T 1792-2021: (Fluorescence immunochromatography analyzer)
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| YY/T 1792-2021 | English | 219 |
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(Fluorescence immunochromatography analyzer)
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YY/T 1792-2021
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Basic data | Standard ID | YY/T 1792-2021 (YY/T1792-2021) | | Description (Translated English) | (Fluorescence immunochromatography analyzer) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Word Count Estimation | 10,178 | | Issuing agency(ies) | State Drug Administration | YY/T 1792-2021: (Fluorescence immunochromatography analyzer)---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.
ICS 11.100.10
C44
People's Republic of China Pharmaceutical Industry Standard
Fluorescence Immunochromatography Analyzer
Published on 2021-09-06
2023-03-01 Implementation
Released by the State Drug Administration
foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may be patented. Publication of this document
Institutions do not assume responsibility for identifying these patents.
This standard is proposed by the State Drug Administration.
This standard is under the jurisdiction of the National Standardization Technical Committee of Medical Clinical Laboratory and In Vitro Diagnostic System (SAC/TC136).
This standard was drafted by. Beijing Medical Device Technology Review Center, China National Institute for Food and Drug Control, Chongqing Medical Device Quality Inspection
Inspection Center, Beijing Medical Device Inspection Institute, Shanghai Aopu Biomedical Co., Ltd., and Jidan Biotechnology Co., Ltd.
The main drafters of this standard. Jiang Yan, Yu Ting, He Lechun, Sun Li, Wang Ding, Chen Wei.
Fluorescence Immunochromatography Analyzer
1 Scope
This standard specifies the requirements, test methods, labeling and instructions for use, packaging, transportation and storage of fluorescence immunochromatography analyzers.
This standard applies to fluorescence immunochromatography analyzers (hereinafter referred to as analyzers) for quantitative analysis of analytes in human samples. analyze
The instrument is used in conjunction with the immunochromatographic reagent card labeled with fluorescent substances, and by measuring the fluorescence intensity of the bands in the reaction zone, it can be used in human samples to be tested.
Quantitative analysis.
This standard does not apply to instruments for the detection of immunochromatographic reagent cards using colloidal gold labeling or other labeling methods.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 191 Graphical signs of packaging, storage and transportation
GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements
GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9.Laboratory use for analysis and other purposes
Particular requirements for automatic and semi-automatic equipment
GB/T 14710 Medical Electrical Environment Requirements and Test Methods
GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements
GB/T 18268.26 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26.Special Requirements
In vitro diagnostic (IVD) medical devices
GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - Part 3.In vitro diagnostic instruments for professional use
YY 0648 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101.In Vitro Diagnostic (IVD) Medical Equipment
specific requirements
3 Terms and Definitions
3.1
Immunochromatographic analysis is a membrane analysis method that combines antigen-antibody specific immune response and chromatography techniques. Fluorescent immune layer
Analytical analysis uses fluorescent substances as tracers to label antigens or antibodies for immunoreaction with the analyte to measure the fluorescence intensity of the final product from
The analytical techniques to obtain the concentration of the analyte, the fluorescent markers mainly include fluorescein, quantum dots, up-conversion nanoparticles and so on.
3.2
Used in conjunction with the fluorescence immunochromatography analysis reagent card, by measuring the fluorescence intensity of the band in the reaction zone, the detection of the analyte in the human sample can be achieved.
An instrument for qualitative or quantitative analysis.
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