YY/T 1874-2023 Electromagnetic compatibility of active implantable medical devices Electromagnetic compatibility test rules for implantable pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices (English Version)
This document specifies electromagnetic compatibility (EMC) testing for the evaluation of active implantable cardiovascular devices designed to provide one or more treatments for bradycardia, tachycardia, and cardiac resynchronization in conjunction with a transvenous lead system method. This document specifies performance limits for such devices when interacting with EM transmitters operating in the following two EM spectrum ranges: 0 Hz ≤ f < 385 MHz; 385 MHz ≤ f ≤ 3000 MHz. This document also specifies the requirements for the protection of such devices from EM fields in medical environments, defines the required accompanying documentation, and provides information on EM transmitter manufacturers and expected immunity levels. This document applies to active implantable cardiovascular devices that provide one or more treatments for bradycardia, tachycardia, and cardiac resynchronization in conjunction with a transvenous lead system.
YY/T 1874-2023 history
2023YY/T 1874-2023 Electromagnetic compatibility of active implantable medical devices Electromagnetic compatibility test rules for implantable pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices