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YY/T 1173-2010

Search Result of Chinese Standard: 'YY/T 1173-2010'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 1173-2010English279 Add to Cart Days<=3 Polymerase chain reaction analyzer Valid YY/T 1173-2010
YY/T 1173-2010Chinese15 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   
Detail Information of YY/T 1173-2010; YY/T1173-2010
Description (Translated English): Polymerase chain reaction analyzer
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 14,199
Date of Issue: 2010-12-27
Date of Implementation: 2012-06-01
Quoted Standard: GB/T 191; GB 4793.1; GB/T 14710; YY/T 0466.1-2009; YY 0648-2008
Drafting Organization: Beijing Medical Device Testing
Administrative Organization: National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems
Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97
Proposing organization: National Medical Clinical Laboratory Laboratory and Standardization Technical Committee for In Vitro Diagnostic System (SAC/TC 136)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies the polymerase chain reaction analyzer terminology and definitions, classification and naming requirements, test methods, marking and instructions, packaging, transport and storage and so on. This standard applies to amplify nucleic acid samples, detection, analysis, PCR instrument.


YY/T 1173-2010
Polymerase chain reaction analyzer
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Polymerase chain reaction analyzer
Issued on: 2010-12-27
2012-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
This standard is to evaluate the polymerase chain reaction analyzer product quality basis.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) proposed.
This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized.
This standard was drafted: Beijing Medical Device Testing, Roche Diagnostics (Shanghai) Co., Ltd., Zhongshan Tat gene Shares
Co., Ltd. Hangzhou Bo Japan, Boao Biological Co.
The main drafters of this standard: Wangrui Xia, Hu Xianghua, Gao Xu, the Yangzong Bing, Liu Zhihua, Liu Yu.
Polymerase chain reaction analyzer
1 Scope
This standard specifies the polymerase chain reaction analyzer (hereinafter referred to as PCR instrument) terms and definitions, classifications and nomenclature, requirements, test side
Law, signs and instructions, packaging, transportation and storage and so on.
This standard applies to the sample nucleic acid amplification, detection, analysis of PCR instrument.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191 Packaging - Pictorial signs
GB 4793.1 measurement, control and laboratory safety requirements for electrical equipment - Part 1: General requirements
GB/T 14710 medical electrical environmental requirements and test methods
Symbols - Part 1 YY/T 0466.1-2009 medical equipment used with medical device labels, labeling and information: General
Claim
YY 0648-2008 measurement, control and laboratory safety requirements for electrical equipment - Part 2-101: In vitro diagnostic (IVD) Medical
With special equipment requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Polymerase chain reaction polymerasechainreaction, PCR
PCR or polymerase chain reaction is a specific DNA or RNA fragments in vitro method of rapid amplification, the
Denaturation - annealing - extension of three basic reaction steps constitution.
3.2
Based on PCR (polymerase chain reaction) technology principle, simulate DNA or RNA replication in a template, primers, and so the presence of a polymerase
Under the conditions, the specific amplification of known sequences, its detection and analysis of equipment.
3.3
The maximum heating rate maximumheatingrate
The heating process module unit time of maximum temperature rise in degrees.
3.4
The average heating rate meanheatingrate
Within the heating process module per unit time of rising average temperatures in degrees.
3.5
The maximum cooling rate maximumcoolingrate
Cooling process module unit time decrease the maximum degree of temperature.
Related standard:   YY/T 1172-2010  YY/T 1174-2010
   
 
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