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Chinese Standard: YY/T 1740.2-2021

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Clinical mass spectrometer—Part 2:Matrix-assisted laser desorption ionization-time of flight mass spectrometer


Standard in brief
Scope of Application:  
YY/T 1740的本部分规定了医用基质辅助激光解吸电离飞行时间质谱仪的要求、试验方法、标识、标签和说明书、包装、运输和贮存。
本部分适用于采用基质辅助激光解吸电离飞行时间质谱技术(简称MALDI-TOF MS)的医用质谱仪,在临床上主要用于临床标本的微生物蛋白指纹图谱鉴定、生物样本的核酸检测等。

Basic information
Standard No:YY/T 1740.2-2021
Standard Name:医用质谱仪 第2部分:基质辅助激光解吸电离飞行时间质谱仪
English Name:Clinical mass spectrometer—Part 2:Matrix-assisted laser desorption ionization-time of flight mass spectrometer
Standard Status:现行
Release Date:2021-09-06
Effective Date:2023-03-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.100.10
CCS Number:C44

Related Standards
Referenced Standards:GB/T 191,GB 4793.1,GB 4793.9,GB 7247.1,GB/T 14710,GB/T 18268.1,GB/T 18268.26,GB/T 29791.3,YY 0648

Publication Information
Number of pages:16
Number of words:26 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2021-10-01

Standard Revision Information
Has Amendment:No

Other Information
Application Dept:国家药品监督管理局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:1740.2
Drafter:邹迎曙、蔡克亚、王成彬、马庆伟、周春喜、刘东来、StefanBerkenkamp、林志敏、冯立平
Drafting Organization:北京市医疗器械检验所、安图实验仪器(郑州)有限公司、中国人民解放军总医院、北京毅新博创公司生物科技有限公司、布鲁克(北京)科技有限公司、中国食品药品检定研究院、基纳生物技术(上海)有限公司、江苏天瑞仪器股份有限公司福建分公司、珠海美华医疗科技有限公司
Management Organization: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)
Proposing Department:国家药品监督管理局

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