DZ/T 0101.12-1994
Active
YY/T 1908-2023
Active
Industry standards-Medicine
YY/T 1908-2023 Nucleic acid extraction system
YY/T 1908-2023 Nucleic acid extraction system
Basic Information
Standard Code:
YY/T 1908-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2023-09-05
Implement Date:
2024-09-15
Publisher:
国家药品监督管理局
Technical Committee:
全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
Pages:
11 pages
Scope
本文件规定了核酸提取仪的要求、试验方法、标签、标识和使用说明、包装、运输和贮存。
本文件适用于对临床样本中核酸的提取、纯化等自动化前处理相关仪器。
Development Information
Drafting Units:
北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、深圳华大智造科技股份有限公司、中国食品药品检定研究院、中国医学科学院北京协和医院、首都医科大学附属北京天坛医院、杭州博日科技股份有限公司、西安天隆科技有限公司、圣湘生物科技股份有限公司、上海思路迪生物医学科技有限公司、凯杰企业管理(上海)有限公司
Drafting Persons:
李达、李景、张文新、伊洁、张国军、商晓辉、田真、邓中平、刘聪智、张希、代蕾颖
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
GB/T 29791.3-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 3:In vitro diagnostic instruments for professional use
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
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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