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GB/T 33806-2017 in English

GB/T 33806-2017 in English

VALID

Technical requirement of area fluorescent imaging microarray 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 33806-2017
Document status: VALID
Title in English: Technical requirement of area fluorescent imaging microarray scanner
Title in Chinese: 面阵荧光成像微阵列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: area array fluorescence imaging microarray chip scanners
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《GB/T 33806-2017面阵荧光成像微阵列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

1. Standard Overview

GB/T 33806—2017 "Technical Requirements for Area Array Fluorescence Imaging Microarray Chip Scanners" is a standard proposed and coordinated by the National Technical Committee for Biochip Standardization, and is mainly applicable to in vitro diagnostic medical devices. This standard specifies in detail the terms and definitions, basic parameters, requirements, test methods, inspection rules, signs, labels and instructions for use, packaging, transportation and storage of area array fluorescence imaging microarray chip scanners (hereinafter referred to as "scanners").

2. Background of Standard Formulation

With the rapid development of biotechnology, microarray chips are increasingly used in the field of life sciences. As an important detection equipment, the performance of area array fluorescence imaging microarray chip scanners directly affects the accuracy of experimental results. In order to standardize the technical requirements of such equipment and ensure product quality and detection consistency, this standard came into being.

3. Comparison of standard frameworks

Chapter Content Overview Requirements and Key Points
1 Scope Specifies the terms and definitions, basic parameters, requirements, etc. of scanners. Applicable to in vitro diagnostic medical devices based on CCD and CMOS detectors.
2 Normative References Lists the necessary reference standards and specifications. Including GB/T 191, GB 4793.1, YY/T0466.1, etc.
3 Terms and Definitions Definition of key terms is clarified. Including "area array fluorescence imaging microarray chip scanner", "microarray chip", etc.

4. Standard Technical Requirements

4.1 Emission Light and Color Filters

The emission light wavelength range of the scanner is 180nm~2000nm, and the color filter must meet the cutoff depth ≥5 OD, and the transmittance of the central wavelength of the light transmission band ≥80%.

4.2 Chip Specifications and Excitation Light

The size of the microarray chip is unlimited, but the imaging area of the scanner must be no less than 0.2mm×0.2mm. The excitation light power requirement is ≥1mW, and the continuous working stability deviation is ≤5%.

4.3 Detector and Operation Mode

The number of detector units is no less than 100, supporting common analog and digital CCD, CMOS, etc. The operation modes include one-shot imaging and partition scanning imaging.


5. Safety and Environmental Adaptability

  • Safety requirements must comply with the provisions of GB 4793.1.
  • Environmental tests must be carried out in accordance with GB/T 14710, including temperature, humidity and atmospheric pressure adaptability tests.
  • Appearance should be clean and scratch-free, moving parts should run smoothly, and fasteners should be firm and reliable.

6. Implementation Suggestions

To ensure the performance and reliability of the scanner, it is recommended that in actual applications:

  1. Equipment selection and procurement should be carried out in strict accordance with standard requirements.
  2. Establish a complete equipment calibration and maintenance system.
  3. Train operators to ensure correct use and interpretation of test results.
  4. Perform environmental adaptability tests regularly to ensure stable operation of the equipment under different conditions.

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