Standard No.:	YY 0989.6-2016
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)
Chinese 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
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.40 11.040.40    Implants for surgery, prosthetics and orthotics 11.040.40
Issued by:	China Food and Drug Adminstration
Issued on:	2016-01-26
Implemented on:	2018-1-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	44500 words
Price(USD):	1330.00
Delivery:	via email in 1~5 business day

本标准规定了具有治疗快速性心律失常功能的有源植入医疗器械的要求和试验方法。
本标准适用于具有治疗快速性心律失常功能的有源植入医疗器械（包括植入式心脏除颤器），以及有源植入医疗器械的某些非植入式部分和附件。