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GB/T 33806-2017 English PDF

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GB/T 33806-2017: Technical requirement of area fluorescent imaging microarray scanner
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Basic data

Standard ID GB/T 33806-2017 (GB/T33806-2017)
Description (Translated English) Technical requirement of area fluorescent imaging microarray scanner
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.55
Word Count Estimation 10,189
Date of Issue 2017-05-31
Date of Implementation 2017-12-01
Quoted Standard GB/T 191; GB 4793.1; GB/T 14710; YY/T 0466.1
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary This standard specifies the terms and definitions, basic parameters, requirements, test methods, inspection rules, signs, labels and instructions, packaging, transportation and storage of the array of surface array fluorescence imaging microarray microarrays (hereinafter referred to as scanners). This standard is suitable for in vitro diagnostic medical devices, based on plane matrix as carrier, based on CCD (Charge Coupled Device) and CMOS (Complementary Metal-Oxide Semiconductor) detector, one and more Photographic imaging microarray chip scanners.

GB/T 33806-2017: Technical requirement of area fluorescent imaging microarray scanner

---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.
Technical requirement of area fluorescent imaging microarray scanner ICS 11.040.55 C30 National Standards of People's Republic of China Surface array fluorescence imaging microarray chip scanners skills requirement 2017-05-31 released 2017-12-01 implementation General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China China National Standardization Management Committee released

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard is proposed and centralized by the National Standardization Technical Committee for Biochip (SAC/TC421). The drafting of this standard unit. Boao Biological Group Co., Ltd. The main drafters of this standard. Huang Guoliang, Liu Yu. Surface array fluorescence imaging microarray chip scanners skills requirement

1 Scope

This standard specifies the terms and definitions of the surface array fluorescence imaging microarray chip scanner (hereinafter referred to as the scanner), the basic parameters, requirements, Test methods, inspection rules, signs, labels and instructions, packaging, shipping and storage. This standard applies to in vitro diagnostic medical devices, based on the plane matrix as the carrier, based on CCD (ChargeCoupledDevice, charge coupling Device) and a CMOS (ComplementaryMetal-Oxide Semiconductor) detector, One and multiple photographed face array fluorescence imaging microarray chip scanners.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191 packaging and storage icon GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1. General requirements Environmental requirements and test methods for medical appliances GB/T YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 terms and definitions

The following terms and definitions apply to this document. 3.1 Face array fluorescence imaging microarray chip scanner areafluorescentimagingmicroarrayscanner The excitation light is converged on the surface of the microarray chip by an optical system, and the optical element is connected to the region The object to be measured is excited by the excitation light generated by the excitation light (fluorescence) to receive, imaging in the CCD (ChargeCoupledDevice, charge coupler ), CMOS (ComplementaryMetal-Oxide Semiconductor, and other array detectors) On the photoelectric conversion, generate analog images or digital images and data files. 3.2 Microarray chip microarray An array of microprocessors capable of arranging a plurality of pieces of information in a biological sample on a planar substrate carrier in an array manner. 3.3 Stability Scanner on the microarray chip to be measured on the target detection signal strength of the ability to reproduce, in the basic to keep the target to send light signal intensity In the case of the same, it is possible to perform repeated operation for a long period of time and intermittent operation. 3.4 Resolution resolution Scanner on the microarray chip to be measured on the target size of the ability to identify the micro-array chip image can be used to identify the size of the smallest target Said.

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