GB/T 41407-2022
Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips (English Version)
- Standard No.
- GB/T 41407-2022
- Language
- Chinese, Available in English version
- Release Date
- 2022
- Published By
- 国家市场监督管理总局、中国国家标准化管理委员会
- Latest
- GB/T 41407-2022
- Scope
- This document specifies the classification and naming, marking, requirements, test methods, inspection requirements, labels, instructions for use, packaging, transportation and storage of microfluidic chip nucleic acid constant temperature amplification instruments. This document is applicable to the production, sale, use and inspection of nucleic acid constant temperature amplification instruments or nucleic acid constant temperature amplification analyzers for centrifuge tube carriers and microfluidic chip carriers. This document does not apply to the polymerase chain reaction (Polras echa i nreaction, PCR) type thermal cycler with periodic temperature changes. yme
GB/T 41407-2022 Referenced Document
- 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: Particular requirements for laboratory material heating equipment
- GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use.Part 9:Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
- GB/T 14710 Enviromental requirement and test methods for medical electrical equipment
- GB/T 18268.1 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 1:General requirements
- GB/T 18268.26 Electrical equipment for measurement,control and laboratory use.EMC requirements.Part 26:Particular requirements.In vitro diagnostic(IVD) medical equipment
- GB/T 191 Packaging.Pictorial marking for handling of goods
- YY 0648 Safety requirments for electrical equipment for measurement,control and laboratory use.Part 2-101:Particular requirments for in vitro diagnostic(IVD）medical equipment
- YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
- YY/T 1173 Polymerase chain reaction analyzer
GB/T 41407-2022 history
- 2022 GB/T 41407-2022 Technical requirement of nucleic acid isothermal amplification analyzer based on microfluidic chips
