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GB/T 42753-2023 English PDF

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US$479.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email.
GB/T 42753-2023: General principles for performance evaluation of quantitative real-time polymerase chain reaction analyzer
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 42753-2023	479	Add to Cart	4 days	General principles for performance evaluation of quantitative real-time polymerase chain reaction analyzer	Valid

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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

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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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of GB/T 42753-2023_English be delivered?

Answer: Upon your order, we will start to translate GB/T 42753-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 2 ~ 4 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of GB/T 42753-2023_English with my colleagues?

Answer: Yes. The purchased PDF of GB/T 42753-2023_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.