Standard No.:	GB 9706.8-2009
English Name:	Medical electrical equipment - Part 2-4: Particular requirements for the safety of cardiac defibrillators
Chinese Name:	医用电气设备　第2-4部分：心脏除颤器安全专用要求
Chinese Classification:	C39    Medical electronic equipment
Professional Classification:	GB    National Standard
ICS Classification:	11.040.10 11.040.10    Anaesthetic, respiratory and reanimation equipment 11.040.10
Source Content Issued by:	AQSIQ; SAC
Issued on:	2009-5-6
Implemented on:	2010-3-1
Status:	superseded
Superseded by:	GB 9706.204-2022 Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
Superseded on:	2024-8-1
Abolished on:	2024-08-01
Superseding:	GB 9706.8-1995 Medical electrical equipment. Part 2: Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors
Target Language:	English
File Format:	PDF
Word Count:	21000 words
Translation Price(USD):	570.0
Delivery:	via email in 1~3 business day

本专用标准规定了在2.1.101中定义的心脏除颤器的安全要求,本文此后称心脏除颤器为设备。
本专用标准不适用于植入式除颤器、遥控除颤器、体外经皮起搏器、分开单立的心脏监护仪(符合GB9706.25)。使用分开的心电监护电极的心脏监护仪不在本标准适用范围内,除非其被作为自动体外除颤器(AED)心律识别检测或同步心电复律的心搏检测的唯一基准使用。
除颤波形技术发展迅速。文献研究表明了不同波形的有效性。本标准的适用范围特意不包括特殊波形的选择,它包括波形形状、释放能量、功效和安全性。
然而,由于治疗波形其重要性是非常关键的,所以原理说明中增加了注释,解释如何考量波形的选择。