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Implants for surgery—Active implantable medical devices—Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)
Basic information
Standard No：YY 0989.6-2016
Standard Name：手术植入物 有源植入医疗器械 第6部分：治疗快速性心律失常的有源植入医疗器械(包括植入式除颤器)的专用要求
English Name：Implants for surgery—Active implantable medical devices—Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)
Standard Status：现行
Release Date：2016-01-26
Effective Date：2018-01-01
Language of Publication：中文简体
Standard Classification
ICS Number：11.040.40
CCS Number：C35
Related Standards
Referenced Standards：IEC 60068-2-27,IEC 60068-2-47,IEC 60068-2-64,IEC 60878,ISO 5841-3,ISO 8601,ISO 11318,ISO 14708-1,ISO 14708-2,ISO 15233-1,ANSI/AAMI/ISO PC69
Adopted Standards：ISO 14708-6:2010
Adopted Standard Name：《手术植入物 有源植入医疗器械 第6部分：治疗快速性心律失常的有源植入医疗器械(包括植入式除颤器)的专用要求》
Adoption Level：IDT
Publication Information
Number of pages：104
Number of words：183 K
Format：大16
Edition：1
Color Pages：0
Electronic Version：Yes
Color Images：No
Print Publication Date：2016-06-01
Standard Revision Information
Has Amendment：No
Other Information
Application Dept：国家食品药品监督管理总局
Standard Type：QT
Standard Attribute：YY
Other Standard Number：0989.6
Drafter：谢琼、倪是成、张夏冰
Drafting Organization：上海市医疗器械检测所
Management Organization：全国医用电器标准化技术委员会医用电子仪器标准化分技术委员会(SAC/TC 10/SC 5)
Proposing Department：国家食品药品监督管理总局
