Standard No.:	YY 9706.231-2023
English Name:	Medical electrical equipment--Part 2-31: Particular requirements for thebasic safety and essential performance of external cardiac pacemakerswith internal power source
Chinese Name:	医用电气设备 第2-31部分：带内部电源的体外心脏起搏器的基本安全和基本性能专用要求
Chinese Classification:	C39    Medical electronic equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Issued by:	National Medical Products Adminstration
Issued on:	2023-03-14
Implemented on:	2026-5-1
Status:	to be valid
Superseding:	YY 0945.2-2015 Medical electrical equipment―Part 2:Particular requirements for the safety of external cardiac pacemakers with internal power source
Language:	English
File Format:	PDF
Word Count:	21500 words
Price(USD):	645.00
Delivery:	via email in 1~5 business day

本文件规定了由内部电源供电的体外心脏起搏器的基本安全和基本性能。
本文件适用于延伸非植入式脉冲发生器和起搏电极导线之间距离的电缆，但不适用于封闭有一根或多根被绝缘的导体，预期用于在体外心脏起搏器和患者心脏之间传输电能的软管。
本文件不适用于GB 16174.1所涵盖的有源植入式医疗器械的植入部分、可以直接或间接连接至供电网的体外心脏起搏器、经胸廓和食管起搏的医用电气设备和抗心动过速的医用电气设备。