YY/T 1173-2010 English PDFUS$329.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1173-2010: Polymerase chain reaction analyzer Status: Valid
Basic dataStandard ID: 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: 14,153 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 Regulation (derived from): State Food and Drug Administration Notice 2010 No. 97 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---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.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 ForewordThis 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 analyzer1 ScopeThis 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 referencesThe 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 requirements3 Terms and DefinitionsThe 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1173-2010_English be delivered?Answer: Upon your order, we will start to translate YY/T 1173-2010_English as soon as possible, and keep you informed of the progress. 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