GB/T 41407-2022 Active National standards

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

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

Publish Date: 2022-04-15 Implement Date: 2022-04-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
Price: $ 44.00
Download

Basic Information

Standard Code: GB/T 41407-2022
Standard Type: National standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical laboratory equipment
ICS Name: Medical equipment
Publish Date: 2022-04-15
Implement Date: 2022-04-15
Pages: 15 pages

Scope

This document specifies the classification and naming, marking, requirements, test methods, inspection requirements, labels, user manuals, packaging, transportation, and storage of microfluidic chip-based nucleic acid thermal amplification instruments. This document applies to the production, sale, use, and inspection of nucleic acid thermal amplification instruments or nucleic acid thermal amplification analyzers using centrifuge tube carriers and microfluidic chip carriers. This document does not apply to polymerase chain reaction (PCR)-based amplifiers with cyclic temperature changes.

Development Information

Word Count: 28 Thousand words Pages: 15 pages

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB 4793.6-2001 Safety requirements for electrical equipment for measurement, control and laboratory use—Particular requirements for laboratory equipment for the heating of materials GB 4793.6-2008 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 6:Particular requirements for laboratory equipment for the heating of materials GB 4793.9-2013 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 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB/T 18268.1-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 18268.26-2010 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 26:Particular requirements—In vitro diagnostic (IVD) medical equipment YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY 0648-2008 Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment YY/T 1173-2010 Polymerase chain reaction analyzer GB/T 18268.1-2025 Electrical equipment for measurement,control and laboratory use—EMC requirements—Part 1:General requirements GB/T 191-2025 Graphical symbols marking for handling and storage of packages YY/T 0648-2025 Safety requirements for electrical equipment for measurement,control,and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD)medical equipment

Related Standards

Contact Us