YY/T 1740.1-2021 Active Industry standards-Medicine

YY/T 1740.1-2021 Clinical mass spectrometer—Part 1:Liquid chromatography-mass spectrometer

YY/T 1740.1-2021 Clinical mass spectrometer—Part 1:Liquid chromatography-mass spectrometer

Publish Date: 2021-03-09 Implement Date: 2022-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1740.1-2021
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical laboratory equipment
ICS Name: Laboratory medicine
Publish Date: 2021-03-09
Implement Date: 2022-10-01
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: 16 pages

Scope

YY/T 1740的本部分规定了医用液相色谱质谱联用仪的要求、试验方法、标签、使用说明、包装、运输和贮存。
本部分适用于单四极杆和三重四极杆型液相色谱质谱联用仪(以下简称液质联用仪),该仪器主要用于分析血液、尿液等人源样本中分子物质,例如蛋白质、代谢小分子、药物等。

Development Information

Drafting Units:

北京市医疗器械检验所、首都医科大学附属北京同仁医院、卫生部临床检验中心、北京协和医院、广州金域医学检验集团有限公司、美康生物科技股份有限公司

Drafting Persons:

彭絮、李胜民、刘向祎、张天娇、程歆琦、赵蓓蓓、沈敏、邹迎曙

Word Count: 24 Thousand words Pages: 16 pages

Same series standard

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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