DZ/T 0101.12-1994
Active
YY/T 1918-2023
Active
Industry standards-Medicine
YY/T 1918-2023 Digital polymerase chain reaction analysis system
YY/T 1918-2023 Digital polymerase chain reaction analysis system
Basic Information
Standard Code:
YY/T 1918-2023
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:
10 pages
Scope
本文件规定了数字聚合酶链反应分析系统（以下简称数字PCR)的分类,要求,试验方法,标签、标识和使用说明,包装、运输和贮存等内容。
本文件适用于对核酸样本以单液滴或单核酸分子方式生成数百个至数百万个独立反应单元的设备，分析系统包括微液滴生成模块、聚合酶链反应模块和微液滴检测模块等。
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)、中国食品药品检定研究院、北京市医疗器械审评检查中心、北京新羿生物科技有限公司、广东永诺医疗科技有限公司、伯乐生命医学产品(上海)有限公司、北京达微生物科技有限公司、苏州思纳福医疗科技有限公司、重庆泛生子生物科技有限公司
Drafting Persons:
李达、黄杰、周海卫、孙嵘、苏世圣、许少飞、王瑞霞、刘靖闻、付军、吴琨、袁成彬
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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