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GB/T 42753-2023: General principles for performance evaluation of quantitative real-time polymerase chain reaction analyzer
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| GB/T 42753-2023 | English | 479 |
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General principles for performance evaluation of quantitative real-time polymerase chain reaction analyzer
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GB/T 42753-2023
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Basic data | Standard ID | GB/T 42753-2023 (GB/T42753-2023) | | Description (Translated English) | General principles for performance evaluation of quantitative real-time polymerase chain reaction analyzer | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | N53 | | Classification of International Standard | 71.040.10 | | Word Count Estimation | 23,269 | | Date of Issue | 2023-05-23 | | Date of Implementation | 2023-12-01 | | Issuing agency(ies) | State Administration for Market Regulation, China National Standardization Administration | GB/T 42753-2023: General principles for performance evaluation of quantitative real-time 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.
ICS 71:040:10
CCSN53
National Standards of People's Republic of China
General rules for performance evaluation of real-time fluorescent quantitative PCR instrument
Released on 2023-05-23
2023-12-01 Implementation
State Administration for Market Regulation
Released by the National Standardization Management Committee
table of contents
Preface I
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Abbreviations 2
5 requirements 2
5:1 Working conditions 2
5:2 Appearance 2
5:3 Security 2
5:4 Environmental adaptability 3
5:5 Electromagnetic Compatibility 3
5:6 Performance requirements 3
6 Evaluation method 4
6:1 Visual inspection 4
6:2 Safety test 4
6:3 Environmental adaptability test 4
6:4 Electromagnetic Compatibility Test 4
6:5 Performance test 4
7 Evaluation Report 10
Appendix A (Informative) The heating and cooling cycle program of the instrument and the layout of sample test holes 11
A:1 Heating and heating cycle program 11
A:2 Hole arrangement for temperature control performance test 11
A:3 Hole arrangement for fluorescence detection performance test 11
A:4 Hole arrangement for overall machine performance test 13
Appendix B (informative) Preparation method of fluorescent reference solution 14
Appendix C (informative) Judgment method for significant difference between two groups of data 15
C:1 Judgment method for significant difference between two groups of data 15
C:2 F distribution quantiles Table 16
C:3 t distribution quantile Table 16
Appendix D (Informative) Report Format Example 17
Reference 19
foreword
This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents"
drafting:
Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents:
This document is proposed by China Machinery Industry Federation:
This document is under the jurisdiction of the National Industrial Process Measurement Control and Automation Standardization Technical Committee (SAC/TC124):
This document was drafted by: China Academy of Inspection and Quarantine, Beijing Institute of Science and Technology Analysis and Testing Institute (Beijing Institute of Physics and Chemistry
Analysis and Testing Center), Suzhou Baiyuan Gene Technology Co:, Ltd:, China Institute of Metrology, Shanghai Institute of Metrology and Testing Technology, Xi'an
Tianlong Technology Co:, Ltd:, Suzhou Yarui Biotechnology Co:, Ltd:, Shanghai Hongshi Medical Technology Co:, Ltd:, Hangzhou Bioer Technology Co:, Ltd:
Co:, Ltd:, Kunpeng Gene (Beijing) Technology Co:, Ltd:, Hangzhou Crystal Scientific Instrument Co:, Ltd:, Shengxiang Biotechnology Co:, Ltd:
Division, Antu Experimental Instrument (Zhengzhou) Co:, Ltd:, Shenzhen Huada Zhizao Technology Co:, Ltd:, Shanghai Keyuan Electronic Technology Co:, Ltd:, Anhui
Wanyi Technology Co:, Ltd:, Heilongjiang Provincial Institute of Metrology and Testing, Maichangchang (Beijing) Biotechnology Co:, Ltd:, China Disease Prediction
Prevention and Control Center Nutrition and Health Institute, Pony Testing Group Co:, Ltd:, Gansu Guoyan Inspection and Testing Co:, Ltd:
The main drafters of this document: Zou Mingqiang, Du Meihong, Xue Qiang, Che Tuanjie, Li Jingwen, Qi Xiaohua, Gao Yunhua, Liang Wen, Wang Sheng, Gong Dajiang,
Wang Xiujun, Qin Rong, Shang Xiaohui, Wang Zi, Ruan Liangfeng, Deng Zhongping, Qiao Jianyong, Li Jing, Guo Caihong, Deng Chenguang, Ding Haiming, Liu Xingju, Li Boyi,
Zhao Yi, Sun Licui, Song Wei, Zhang Ying, Chen Erning:
General rules for performance evaluation of real-time fluorescent quantitative PCR instrument
1 Scope
This document specifies the requirements, evaluation methods and evaluation reports for real-time fluorescent quantitative PCR instruments:
This document is applicable to the performance evaluation of real-time fluorescent quantitative PCR instruments, including fluorescent quantitative PCR instruments for medical clinical diagnosis and general analysis:
Fluorescence quantitative PCR instrument was used for analysis: Refer to this document for other devices for quantitative or qualitative analysis of target nucleic acid fragments based on the principle of polymerase chain reaction
implement:
2 Normative references
The contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references
For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to
this document:
GB/T 11606 Environmental test methods for analytical instruments
GB/T 14710 Environmental requirements and test methods for medical electrical appliances
GB/T 18268:1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements
GB/T 18268:26 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26: Particular Requirements for In Vitro
Diagnostic (IVD) medical devices
GB/T 34065-2017 Safety requirements for analytical instruments
GB/T 34797 Quality technical requirements for nucleic acid primers and probes
GB/T 35542 TaqDNA polymerase
YY0648 Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: In vitro diagnostic (IVD) medical equipment
specific requirements for
3 Terms and Definitions
The following terms and definitions apply to this document:
3:1
Based on the principle of polymerase chain reaction, the target nucleic acid fragments are amplified in vitro through the temperature change cycle program, and the
An instrument for real-time acquisition and processing of fluorescent signals, and quantitative or qualitative analysis of target nucleic acid fragments:
3:2
Ct valueCyclethresholdvalue
The number of cycles experienced when the fluorescent signal in each PCR reaction tube reaches the set threshold:
3:3
Constant temperature stage thermostaticprocess
The average temperature of the hole position of the instrument reaches the set value (deviation within ±0:5°C) and maintains the temperature for a period of time:
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