GB/T 33805-2017 in English

VALID

Technical requirement of laser confocal biochip scanner

Issued on:2017-05-31
Implemented on:2017-12-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	GB/T 33805-2017
Document status:	VALID
Title in English:	Technical requirement of laser confocal biochip scanner
Title in Chinese:	激光共聚焦生物芯片扫描仪技术要求
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2017-05-31
Implemented on:	2017-12-01
ICS Classification:	11.040.55-Diagnostic equipment
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	GB-National Standard
Related Keywords:	confocal biochip scanner introduction technical requirements confocal biochip scanner confocal biochip scanners technical parameters requirements test methods practical implications resolution less technical requirement
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《GB/T 33805-2017激光共聚焦生物芯片扫描仪技术要求》由TC421（全国生物芯片标准化技术委员会）归口，主管部门为国家标准化管理委员会。

Introduction

Technical requirements and standard interpretation of laser confocal biochip scanners

1. Background and significance of standard formulation

With the rapid development of biotechnology, microarray chips have been widely used in disease diagnosis, gene expression analysis and other fields. In order to ensure the technical performance and reliability of laser confocal biochip scanners, the National Standard of the People's Republic of China GB/T 33805-2017 came into being.

This standard was proposed and coordinated by the National Technical Committee for Biochip Standardization, and the main drafting units include Biobio Group Co., Ltd. and Beijing Medical Device Inspection Institute. The formulation of the standard provides a unified technical specification to ensure the performance of the instrument and promotes the healthy development of the industry.

Technical Parameters	Requirements	Test Methods	Practical Implications
Resolution	Less than or equal to 20 μm/pixel	Test the scan area of a standard format assay chip using manufacturer-optimized scan parameters.	Ensure the instrument is capable of capturing high-resolution images to meet the needs of microarray analysis.
Minimum Response	Less than or equal to 1 fluorescent molecule/μm²	Scan a standard format assay chip and calculate the signal-to-noise ratio.	Measure the instrument's ability to identify low-concentration signals to ensure sufficient sensitivity.
Linear range	Greater than or equal to 3 orders of magnitude (R² ≥ 0.99)	Plot the logarithmic values to examine the linear fitting correlation coefficient of the curve.	Ensure that the instrument maintains a linear response over a wide concentration range, suitable for multi-sample testing.

2. Comparative Analysis of Standard Frameworks

The following is a comparison of technical parameters under different standard frameworks to help users better understand the characteristics and advantages of GB/T 33805—2017:

Standard Framework	Resolution (μm/pixel)	Minimum Response Value (Fluorescent Molecules/μm²)	Linear Range (Order of Magnitude)
GB/T 33805—2017	≤20	≤1	≥3
Reference Standard A	≤25	≤2	≥2
Reference Standard B	≤15	≤0.5	≥4

3. Detailed Explanation of Technical Parameters and Practical Applications

3.1 Resolution

Resolution is a key indicator of the clarity of the image scanned by the instrument, and the unit is usually microns/pixel. High resolution means that it can capture more delicate signal distribution and is suitable for the detection of high-density microarray chips.

3.2 Limit of Blank

The minimum response value reflects the instrument's ability to recognize weak fluorescence signals. In practical applications, this parameter directly affects the detection sensitivity of low-concentration samples.

3.3 Linear Range

The linear range is the proportional relationship between the instrument's measurement results and the actual sample concentration. A wide linear range means that the instrument can handle samples with a larger dynamic range and reduce data deviation.

4. Implementation Suggestions

In actual applications, it is recommended that users select and use a laser confocal biochip scanner that meets the standards according to the following steps:

Verify technical parameters: Ensure that the instrument meets key indicators such as resolution, minimum response value and linear range.
Test environmental conditions: Test in accordance with the requirements of climate environment group I and mechanical environment group I in GB/T14710.
Operation specification training: Train operators on standardized operating procedures and safety precautions.
Regular maintenance and calibration: Perform regular maintenance according to the instruction manual to ensure stable instrument performance.

More samples: NB/T 47013.2-2015 DL/T 368-2010 QC/T 942-2021

Sample only — not a preview of GB/T 33805-2017

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