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ISO 14117-2012
中文名称：有源植入式医疗设备 - 电磁兼容性 - 可植入心脏起搏器 植入式心律转复除颤器和心脏再同步装置的EMC测试协议
英文名称：Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
| 中国标准分类(CCS)： | C30/49 |
| 国际标准分类(ICS)： | 11.040.40 |
| 发布日期： | 2012-7-10 |
| 实施日期： | 2012/7/10 |
| 页数： | 106 |
| 标准状态： | 作废 |
| 点击数： | 335 |
| 更新日期： | 2020-10-26 |
| 适用范围： | ISO 14117:2012 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 MHz. ISO 14117:2012 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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