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YY/T 1304.1-2015: Detection system of time-resolved fluoroimmenoassay. Part 1: Semi-auto time-resolved fluoroimmunoassay analyser
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1304.1-2015	English	169	Add to Cart	3 days [Need to translate]	Detection system of time-resolved fluoroimmenoassay. Part 1: Semi-auto time-resolved fluoroimmunoassay analyser

YY/T 1304.1-2015: Detection system of time-resolved fluoroimmenoassay. Part 1: Semi-auto time-resolved fluoroimmunoassay analyser

---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.
Detection system of time-resolved fluoroimmenoassay.Part 1. Semi-auto time-resolved fluoroimmunoassay analyser ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Time-resolved fluorescence immunoassay system Part 1. semi-automatic time-resolved fluorescence Immunoassay analyzer Part 1. Semi-autotime-resolvedfluoroimmunoassayanalyser Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Foreword

YY/T 1304 "time-resolved fluorescence immunoassay system" intended to publish in parts, currently plans to release the following components. --- Part 1. semi-automatic time-resolved fluorescence immunoassay analyzer; --- Part 2. Time-resolved fluorescence immunoassay quantitative assay reagent (kit); --- Part 3. Automatic time-resolved fluorescence immunoassay analyzer. This section YY/T 1304 Part 1. This section drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This part is proposed by the China Food and Drug Administration. This part of the National Medical clinical testing laboratory and in-vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This section is drafted. Beijing Medical Device Testing, Guangzhou Dagro Antibody Engineering Technology Co., Ltd., Suzhou New Wave Bio Technology Co., Ltd. The main drafters of this section. Zhang Xinmei, Wuying Song, Huangzhe Feng, Du Haiou. Time-resolved fluorescence immunoassay system Part 1. semi-automatic time-resolved fluorescence Immunoassay analyzer

1 Scope

YY/T 1304 This section provides a semi-automatic time-resolved fluorescence immunoassay analyzer (hereinafter referred to as the analyzer) terms and definitions, to Sum test methods, marking, labeling and instructions for use, packaging, transport and storage. This section applies to a single mark time-resolved fluorescence immunoassay. This section does not apply to more than double labeling and marking time-resolved fluorescence immunoassay.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1. General requirements GB/T 14710 medical electrical environmental requirements and test methods GB/T 18268.1 measurement, control and laboratory use EMC requirements for electrical equipment Part 1. General requirements GB/T 18268.26 measurement, control and laboratory use EMC requirements for electrical equipment Part 26. Particular requirements for body External diagnostic (IVD) medical equipment YY 0648 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101. In vitro diagnostic (IVD) medical equipment Special requirements

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Time-resolved fluorescence immunoassay time-resolvedfluoroimmunoassay; TRFIA The time-resolved fluorescence immunoassay and combine rare earth ions and their chelates as tracers, labeled antigen or antibody test Was subjected to a series of immune reactions, the final product was measured to obtain the fluorescence intensity of the analyte concentration analysis. 3.2 Semi-automatic time-resolved fluorescence immunoassay analyzer semi-autotime-resolvedfluoroimmunoassayanalyser Manual or otherwise finished adding the sample, add reagents, mixing, washing, incubation and other parts or all of the work, and then automatically by the instrument Testing, calculations, report the result of time-resolved fluorescence immunoassay analyzer.

4 Requirements

4.1 Appearance Appearance should meet the following requirements. ...