GB/T 33805-2017Technical requirement of laser confocal biochip scanner (English PDF)
激光共聚焦生物芯片扫描仪技术要求
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
May 31, 2017
Implementation date
December 1, 2017
Scope
GB/T 33805-2017 is the English-translated version of 激光共聚焦生物芯片扫描仪技术要求.
GB/T 33805-2017 is the Chinese national specification for laser confocal biochip scanners. It gives the terms and definitions, the requirements, the test methods, the signs, labels and instructions for use, and the packaging, transport and storage of the instrument.
Among the terms it defines are the laser confocal biochip scanner itself, the microarray chip, the resolution, which is the effectively scanned pixel side in the image and is usually expressed in microns per pixel, and the linear range.
It applies to in vitro diagnostic medical devices that use a plane matrix as the carrier and work on the laser confocal principle. It cites GB/T 191, GB 4793.1, GB/T 14710, YY 0466 and YY 0648. It was issued on 31 May 2017 and has applied since 1 December 2017.
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Document preview — GB/T 33805-2017
National Standard of the People's Republic of China
- ICS
- 11.040.55
- Classification
- C 30
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative reference documents
- 3 Terms and definitions
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).
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 document. 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
GB/T 14710 Environmental requirements and test methods for medical appliances
YY 0466 Medical devices are used for medical device labeling, marking and providing information symbols
YY 0648 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
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
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
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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 4793.1Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- YY 0466Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
- YY 0648Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
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Related Standards
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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GB/T 33805-2017
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