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YY/T 1792-2021: (Fluorescence immunochromatography analyzer)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1792-2021	English	219	Add to Cart	3 days [Need to translate]	(Fluorescence immunochromatography analyzer)

YY/T 1792-2021: (Fluorescence immunochromatography analyzer)

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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. ...