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Electromagnetic Compatibility (EMC) refers to the ability of electrical equipment or systems to operate without causing electromagnetic interference to their environment or being susceptible to such interference. As a critical quality benchmark, EMC compliance should be addressed during the initial product design phase through cost-effective countermeasures. By definition, EMC comprises Electromagnetic Interference (EMI) and Electromagnetic Susceptibility (EMS).
Electromagnetic Compatibility (EMC) refers to the ability of electrical equipment or systems to operate without causing electromagnetic interference to their environment or being susceptible to such interference. As a cr···
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.
