电磁兼容性( EMC )指电气设备或系统运行时,对其所处的电磁环境不产生干扰或抵抗电磁环境干扰的能力。 EMC 是评价产品质量好坏的重要标准之一。为了以最为经济的方式保证产品的 EMC 质量,应该在产品设计初期采取适当的措施。根据定义， EMC 被分为电磁干扰( EMI )、电磁抗扰度或敏感度( EMS )。法规规定应满足 EMI 的最大值和 EMS 最小值。相关标准中对于可用的限值、采用的测量方法和仪器都作出了规定。
电磁兼容性( EMC )指电气设备或系统运行时,对其所处的电磁环境不产生干扰或抵抗电磁环境干扰的能力。 EMC 是评价产品质量好坏的重要标准之一。为了以最为经济的方式保证产品的 EMC 质量,应该在产品设计初期采取适当的···
This standard specifies the general requirements for the basic safety and essential performance of Medical Electrical Equipment (ME Equipment) and Medical Electrical Systems (ME Systems). It is applicable to the design, production, inspection, and use of various medical electrical equipment. Compared with the previous edition, the new version introduces the concept of risk management, making the safety testing requirements more systematic and rigorous.
Active medical devices rely on electrical energy and act directly on the human body, with safety requirements far exceeding those of ordinary electronic equipment. Insufficient electromagnetic compatibility may interfere with the operation of other instruments, leading to device malfunction or data distortion, directly threatening patient safety. EMC testing systematically verifies the electromagnetic compatibility of devices, building a full-chain quality defense from design to use, serving as the "technical gatekeeper" for ensuring device safety and effectiveness.
