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YY/T 0692-2008: Fundamental terms for biochips
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YY/T 0692-2008: Fundamental terms for biochips

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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. ...