Standard No.:	YY 0989.6-2025
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 有源植入式医疗器械 第6部分：治疗快速性心律失常的有源植入式医疗器械（包括植入式除颤器）的专用要求
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	NMPA
Issued on:	2025-06-18
Implemented on:	2028-7-1
Status:	to be valid
Superseding:	YY 0989.6-2016 Implants for surgery―Active implantable medical devices―Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)
Target Language:	English
File Format:	PDF
Word Count:	26000 words
Translation Price(USD):	780.0
Delivery:	via email in 1~8 business day

本文件规定了治疗快速性心律失常的有源植入式医疗器械（包括植入式除颤器）的要求。
本文件适用于植入式心律转复除颤器、植入式心脏再同步治疗/除颤器、具有治疗快速性心律失常功能的有源植入式医疗器械以及有源植入式医疗器械的某些非植入式部件和附件。
本文件不适用于治疗缓慢性心律失常或心脏再同步的有源植入式医疗器械。GB 16174.2-2024规定了此类要求。