YY/T 1874-2023 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers,implantable cardioverter defibrillators and cardiac resynchronization devices

Scope

This document specifies the electromagnetic compatibility (EMC) test methods for active implantable cardiovascular devices used to evaluate the treatment of bradycardia, tachycardia, and cardiac resynchronization, which can be provided with a venous electrode lead system.
Note: This document is designed for use with pulse generators that are compatible with endocardial or epicardial electrode leads. For pulse generators that do not use endocardial or epicardial electrode lead technology, manufacturers using these technologies can adjust them as needed.
This document specifies the performance limits of such devices when they interact with EM transmitters that can operate within the following two EM spectrum ranges:
—— 0 Hz≤f<385 MHz;
—— 385 MHz≤f≤3,000 MHz.
This document also specifies the requirements for protecting such devices from the effects of EM fields in medical environments, defines the required accompanying documents, and provides information about the EM transmitter manufacturer and the expected immunity level.
This document applies to active implantable cardiovascular devices that can be provided with a venous electrode lead system for one or more treatments of bradycardia, tachycardia, and cardiac resynchronization.

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