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YY/T 0692-2008: Fundamental terms for biochips
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| YY/T 0692-2008 | English | 359 |
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Fundamental terms for biochips
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YY/T 0692-2008
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Basic data | Standard ID | YY/T 0692-2008 (YY/T0692-2008) | | Description (Translated English) | Fundamental terms for biochips | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 01.040.11 | | Word Count Estimation | 9,983 | | Date of Issue | 2008-10-17 | | Date of Implementation | 2010-01-01 | | Regulation (derived from) | SFDA [2008] No. 605 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the basic terms and definitions biochip to facilitate biochip research, development, production and use of all parties, as well as cooperation between the competent authorities, communication and exchange. | YY/T 0692-2008: Fundamental terms for biochips---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.
Fundamental terms for biochips
ICS 01.040.11
C30
People's Republic of China pharmaceutical industry standards
Biochip basic terms
Posted 2008-10-17
2010-01-01 implementation
State Food and Drug Administration issued
Foreword
This standard by the Beijing Medical Device Testing, Boao Biological Co. raised.
This standard by the national medical clinical testing laboratory and diagnostic systems in vitro Standardization Technical Committee.
This standard was drafted. Boao Biotechnology Co., Ltd., Beijing Medical Device Testing, Southeast University, West Anhua Zhou biotechnology companies.
The quasi-standard main drafter. Wu Kuo-tung, He Xueying, Wang Xianhua, Luo Jin, Xiao Pengfeng.
Biochip basic terms
1 Scope
This standard specifies the basic terms and definitions biochips, biochip to facilitate research, development, production and use of parties, and the main
Cooperation, communication and exchange between the authorities.
2 Terms and definitions
2.1
In parallel processing complex in a biological sample of plurality of micro processing unit of information.
2.2
It is set in an array on a planar substrate support assembly capable of parallel processing micro processing unit of the plurality of information in a biological sample.
NOTE. lattice arrangement within the spot diameter of 500μm, center to center spacing between adjacent points in less than 1000μm.
2.3
The object to be detected, including biological macromolecules and small molecules of two substances.
2.4
Capable of specifically binding to the target molecule.
2.5
Provided on the microarray quality control point, regardless of how the results of experimental subjects, can produce a signal that can be identified.
Note. The positive control, including chip manufacturing, testing and other biochemical reactions and results of the positive control.
2.6
Provided on the microarray quality control point, regardless of how the results of experimental subjects, will not produce a signal that can be recognized.
Note. Negative controls included chip manufacturing, testing and other biochemical reactions and results of a negative control.
2.7
Microarray chips for flat substrates fixed biomolecules, which has a smooth surface and can be modified characteristics. May be glass,
Nylon film, silicon, plastic and ceramics.
2.8
The nucleic acid molecules as probes a biochip.
2.9
The surface of the substrate in the form of a microarray DNA molecules and/or classes of DNA molecules as probes fixed biochip.
NOTE. DNA molecule and the DNA molecule class includes cDNA, oligonucleotides and peptide nucleic acids.
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