标准编号：ISO 14117:2012
中文名称：有源植入性医疗器械 电磁兼容性 植入式心脏起博器、植入式心律转复除颤器和心脏再同步装置的电磁兼容性（EMC）试验协议
英文名称：Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization device
发布日期：2012-07
标准范围
This International Standard specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization.It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:0 Hz ≤ f < 450 MHz;450 MHz ≤ f ≤ 3 000 MHzThis International Standard also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.
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