Standard No.:	YY 1079-2008
English Name:	Electrocardiographic monitors
Chinese Name:	心电监护仪
Chinese Classification:	C39    Medical electronic equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Administration
Issued on:	2008-04-25
Implemented on:	2009-12-1
Status:	valid
Superseding:	YY 91079-1999 Electro cardiac moniting equipment
Target Language:	English
File Format:	PDF
Word Count:	25000 words
Translation Price(USD):	750.0
Delivery:	via email in 1~3 business day

本标准对预期在本标准所规定的工作条件下使用的采用心电图方法获得心率和波形的监护仪，确立了最低性能要求。这类监护仪的下列所有部分应满足本标准：
ａ）从患者身体通过无创心电检测获得心率显示；
ｂ）放大和传输这些信号，显示心率和／或心电波形；以及
ｃ）基于可调的报警限对持续发生的与心率相关的下列现象提供报警：心脏停跳、心动过缓、和／或心动过速。