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GB/T 41407-2022 English PDF

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GB/T 41407-2022: Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips
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GB/T 41407-2022English329 Add to Cart 4 days [Need to translate] Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips Valid GB/T 41407-2022

PDF similar to GB/T 41407-2022


Standard similar to GB/T 41407-2022

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Basic data

Standard ID GB/T 41407-2022 (GB/T41407-2022)
Description (Translated English) Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips
Sector / Industry National Standard (Recommended)
Classification of Chinese Standard C44
Word Count Estimation 16,191
Issuing agency(ies) State Administration for Market Regulation, China National Standardization Administration

GB/T 41407-2022: Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips


---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.
Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips ICS 11.040 CCSC44 National Standards of People's Republic of China Microfluidic chip nucleic acid isothermal amplification instrument technical requirements 2022-04-15 Implementation State Administration for Market Regulation Released by the National Standardization Administration directory Preface III 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Classification and naming 2 5 Requirements 3 6 Test method 5 7 Logos, Labels and Instructions 9 8 Packaging, Shipping and Storage 10 Reference 12

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 of Standardization Documents" drafted. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed and managed by the National Biochip Standardization Technical Committee (SAC/TC421). This document is drafted by. Boao Biological Group Co., Ltd., Beijing Boao Jingdian Biotechnology Co., Ltd., Tsinghua University, Sichuan University Hua Western Hospital, You'an Hospital Affiliated to Capital Medical University, Peking University People's Hospital. The main drafters of this document. Huang Guoliang, Huang Qin, Luo Xianbo, Li Ruoran, Xing Wanli, Xin Juan. Microfluidic chip nucleic acid isothermal amplification instrument technical requirements

1 Scope

This document specifies the classification and nomenclature, marking, requirements, test methods, inspection requirements, labels, use of microfluidic chip nucleic acid thermostatic amplifiers Instructions, packaging, transportation and storage. This document is applicable to the production of nucleic acid isothermal amplification instrument or nucleic acid isothermal amplification analyzer of centrifuge tube carrier and microfluidic chip carrier, Sale, use and inspection.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Graphical signs of packaging, storage and transportation GB 4793.1 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1.General Requirements GB 4793.6 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 6.Characteristics of Laboratory Material Heating Equipment special requirements GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9.Laboratory use for analysis and other purposes Particular requirements for automatic and semi-automatic equipment 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.Special Requirements In vitro diagnostic (IVD) medical devices YY/T 0466.1 Medical Devices Symbols for Medical Device Labeling, Marking and Providing Information Part 1.General Requirements YY0648 Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 2-101.In Vitro Diagnostic (IVD) Medical Equipment specific requirements YY/T 1173 Polymerase chain reaction analyzer

3 Terms and Definitions

YY/T 1173 and the following terms and definitions apply to this document. 3.1 After the temperature is raised from room temperature to a fixed amplification temperature, the nucleic acid (including DNA and RNA) is rapidly replicated in vitro at the fixed temperature The process of magnification. Note. Due to the different polymerases and primers used, there are certain differences in the temperature value of high temperature amplification, which needs to be optimized according to the actual experimental conditions. 3.2 With the function of constant temperature control, the specific amplification of nucleic acid sequences is carried out by means of a fixed amplification high temperature, which is received by the optical system.

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