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GB/T 33805-2017: Technical requirement of laser confocal biochip scanner
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 33805-2017 | English | 179 |
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Technical requirement of laser confocal biochip scanner
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GB/T 33805-2017
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Basic data | Standard ID | GB/T 33805-2017 (GB/T33805-2017) | | Description (Translated English) | Technical requirement of laser confocal biochip scanner | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.55 | | Word Count Estimation | 9,996 | | Date of Issue | 2017-05-31 | | Date of Implementation | 2017-12-01 | | Quoted Standard | GB/T 191; GB 4793.1; GB/T 14710; YY 0466; YY 0648 | | 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 of laser confocal biochip scanners, requirements, test methods, marking, labeling and instructions for use, packaging, transport and storage. This standard applies to medical devices for in vitro diagnostics, based on planar matrix as a carrier, based on laser confocal principle. | GB/T 33805-2017: Technical requirement of laser confocal biochip 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 laser confocal biochip scanner
ICS 11.040.55
C30
National Standards of People's Republic of China
Laser confocal biochip
Scanner technical requirements
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., Beijing Medical Device Testing Institute.
The main drafters of this standard. Wang Dong, Liu Yu, Teng Huihui, Mei Danyang.
Laser confocal biochip
Scanner technical requirements
1 Scope
This standard specifies the terms and definitions of laser confocal biochip scanners, requirements, test methods, signs, labels and instructions for use,
Packaging, transportation and storage.
This standard applies to in vitro diagnostic medical devices, based on the plane matrix as the carrier, based on the laser confocal principle of the scanner.
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
YY0466 Medical devices are used for medical device labeling, marking and providing information symbols
YY0648 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101. In vitro diagnostic (IVD) medical equipment
Of the special requirements
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Laser confocal biochip scanner laserconfocalbiochipscanner
Through the optical system to converge the excitation light on the chip to be tested, based on the laser confocal scanning microscope principle, through the optical components on the chip
Of the fast scan to obtain the fluorescent data of the instrument.
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
Resolution resolution
Effectively scan the pixel side in the image.
Note. Units are usually microns/pixels.
3.4
Linear range
The measured results are given a range of measurement that is directly proportional to the value measured in the sample.
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