Standard Number: YY 9706.231-2023(YY9706.231-2023)
Chinese: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
English:Medical electrical equipment-Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
Effective Date:2026-05-01
ICS:11.040.01
Standard Applicability:This document specifies the basic safety and essential performance of extracorporeal cardiac pacemakers that are powered by an internal power supply. This document applies to cables that extend the distance between a non-implantable pulse generator and a pacing electrode lead, but does not apply to hoses enclosed with one or more insulated conductors that are intended to be used for the transmission of electrical energy between an extracorporeal cardiac pacemaker and the patient’s heart. This document does not apply to the implanted parts of active implantable medical devices covered by GB 16174.1, extracorporeal cardiac pacemakers that can be connected directly or indirectly to the power supply grid, medical electrical equipment for trans-thoracic and esophageal pacing, and medical electrical equipment for anti-tachycardia.
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