DZ/T 0101.12-1994
Active
YY/T 1740.3-2024
Active
Industry standards-Medicine
YY/T 1740.3-2024 Clinical mass spectrometer—Part 3:Inductively coupled plasma mass spectrometry
YY/T 1740.3-2024 Clinical mass spectrometer—Part 3:Inductively coupled plasma mass spectrometry
Basic Information
Standard Code:
YY/T 1740.3-2024
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2024-02-07
Implement Date:
2025-03-01
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
本文件规定了医用电感耦合等离子体质谱仪的要求、标签、使用说明、包装、运输和贮存,描述了相应的试验方法。本文件适用于医用电感耦合等离子体质谱仪(ICPMS),该仪器主要用于分析人源样本中的无机元素,如钾、钙、锌、碘等。
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)、首都医科大学附属北京同仁医院、浙江省医疗器械审评中心、中国人民解放军总医院第一医学中心、山东英盛生物技术有限公司、瑞莱谱(杭州)医疗科技有限公司、天津国科医疗科技发展有限公司、北京毅新博创生物科技有限公司、美康生物科技股份有限公司
Drafting Persons:
李胜民、刘向祎、叶朝付、段晋燕、崔文斌、郑毅、程文播、马庆伟、沈敏、赵丙锋
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 4793.9-2013 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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