Standard No.:	YY 0945.2-2015
English Name:	Medical electrical equipment―Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source
Chinese Name:	医用电气设备 第2部分：带内部电源的体外心脏起搏器安全专用要求
Chinese Classification:	C35    Orthopedic devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Issued by:	China Food and Drug Adminstration
Issued on:	2015-03-02
Implemented on:	2017-1-1
Status:	to be superseded
Superseded by:	YY 9706.231-2023 Medical electrical equipment--Part 2-31: Particular requirements for thebasic safety and essential performance of external cardiac pacemakerswith internal power source
Superseded on:	2026-5-1
Language:	English
File Format:	PDF
Word Count:	10500 words
Price(USD):	310.00
Delivery:	via email in 1~5 business day

本标准规定了带内部电源的体外心脏起搏器和患者电缆（若使用）的安全专用要求。
本标准适用于带内部电源的体外心脏起搏器和患者电缆（若使用）。
本标准不适用于直接或间接连到供电网的设备，也不适用于起搏电极或其它用于心电刺激的设备，如从外部通过胸腔或食道刺激的设备、在高速起搏上提供抗心动过速能量的设备、提供起搏系统分析功能的设备。