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

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
Publisher: 国家市场监督管理总局、国家标准化管理委员会
Technical Committee: 全国生物芯片标准化技术委员会(SAC/TC 421)
Pages: 15 pages

Scope

本文件规定了微流控芯片核酸恒温扩增仪的分类和命名、标记、要求、试验方法、检验要求、标签、使用说明书、包装、运输和储存。本文件适用于离心管式载体和微流控芯片载体的核酸恒温扩增仪或核酸恒温扩增分析仪的生产、销售、使用和检验。本文件不适用于周期性变温的聚合酶链反应(Polymerase chain reaction,PCR)类扩增仪。

Development Information

Drafting Units:

博奥生物集团有限公司、北京博奥晶典生物技术有限公司、清华大学、四川大学华西医院、首都医科大学附属佑安医院、北京大学人民医院

Drafting Persons:

黄国亮、黄琴、罗贤波、李若然、邢婉丽、辛娟

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

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