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GB/T 41407-2022Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips (English PDF)

微流控芯片核酸恒温扩增仪技术要求

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Issued by

SAMR; SAC

Level / Type

National · Recommended

Issue date

April 15, 2022

Implementation date

April 15, 2022

Scope

GB/T 41407-2022 is the English-translated version of 微流控芯片核酸恒温扩增仪技术要求.

GB/T 41407-2022 sets the technical requirements of the nucleic acid isothermal amplification analyser built on a microfluidic chip.

It gives the classification and the naming, the marking, the requirements - the temperature control, the optical detection, the fluidics, the software, the safety and the electromagnetic compatibility - the test methods, the inspection requirements, the labels and the instructions for use, and the provisions on packaging, transport and storage.

It applies to the production, sale, use and inspection of these analysers, both the centrifuge tube and the microfluidic chip types. Instrument makers, laboratories and inspection bodies use it. Issued on 15 April 2022, it applies from the same date.

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Document preview — GB/T 41407-2022

National Standard of the People's Republic of China

ICS: 11.040
Classification: C 44

Issued by: State Administration for Market Regulation; Standardization Administration of the PRC

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Classification and naming
5 Requirements
6 Test method
7 Logos, Labels and Instructions
8 Packaging, Shipping and Storage
Reference

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.

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 Nucleic acid isothermal amplification

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 Nucleic acid isothermal amplification analyser

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Referenced standards

Normative references

GB 4793.9

Similar standards

GB/T 48033-2026|YY/T 0297-2026|YY/T 1997-2026|YY/T 1998-2026|YY/T 2000-2026|YY/T 1973-2025

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