标准编号：ISO 14117:2019
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：2019-09
标准范围
This document 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 in conjunction with transvenous lead systems.
NOTE This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
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 ≤ ƒ < 385 MHz;
— 385 MHz ≤ ƒ ≤ 3 000 MHz
This document 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.
ISO 14708-1:2014, Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO 14708-2:2019, Implants for surgery — Active implantable medical devices — Part 2: Cardiac pacemakers
ISO 14708-6:2019, Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
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