GB/T 41407-2022_English: PDF (GB/T41407-2022)
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Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips
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GB/T 41407-2022
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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 | Classification of International Standard | 11.040 | Word Count Estimation | 16,171 | Date of Issue | 2022-04-15 | Date of Implementation | 2022-04-15 | Drafting Organization | Boao Biological Group Co., Ltd., Beijing Boao Jingdian Biotechnology Co., Ltd., Tsinghua University, West China Hospital of Sichuan University, You'an Hospital Affiliated to Capital Medical University, Peking University People's Hospital | Administrative Organization | National Biochip Standardization Technical Committee (SAC/TC 421) | Proposing organization | National Biochip Standardization Technical Committee (SAC/TC 421) | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration |
GB/T 41407-2022
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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