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Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment
Standard in brief
Scope of Application：
替换：
本标准适用于预期用作体外诊断（IVD）医用目的，包括自测体外诊断医用目的的设备。
Basic information
Standard No：YY 0648-2008
Standard Name：测量、控制和实验室用电气设备的安全要求 第2-101部分：体外诊断(IVD)医用设备的专用要求
English Name：Safety requirements for electrical equipment for measurement,control and laboratory use—Part 2-101:Particular requirements for in vitro diagnostic (IVD) medical equipment
Standard Status：现行
Release Date：2008-04-25
Effective Date：2009-12-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.100
CCS Number：C44
Related Standards
Adopted Standards：IEC 61010-2-101:2002
Adoption Level：IDT
Publication Information
Number of pages：20
Number of words：26 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2008-08-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家食品药品监督管理局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0648
Drafter：曾宁、韩晓鹏、章兆园
Drafting Organization：北京市医疗器械检验所
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
Proposing Department：国家食品药品监督管理局
