YY/T 1935-2024 Active Industry standards-Medicine

YY/T 1935-2024 Requirements and test methods for safety of implantable pacemakers and cardioverter defibrillators exposed to magnetic resonance imaging

Publish Date: 2024-07-08 Implement Date: 2025-07-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1935-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2024-07-08

Implement Date: 2025-07-20

Pages: 120 pages

Scope

This document specifies the safety requirements for implantable pacemakers and cardioverter-defibrillators operating under the stimulation of whole-body coils in 1.5 T and 3.0 T cylindrical (round or elliptical cross-section) scanning bore whole-body magnetic resonance imaging (MRI) equipment, and describes the corresponding testing methods.
This document applies to implantable pacemakers and cardioverter-defibrillators that meet the following conditions:
—— Systems that do not use sensing functions or are programmed to not use sensing functions during MRI scanning;
—— Systems that disable high-voltage therapy during MRI scanning;
—— Devices implanted in the patient's chest area.
This document does not apply to the non-implanted parts of active implantable medical devices.
Note 1: Subcutaneous ICD systems, leadless pacemakers, and implantable electrocardiograph recorders are not within the scope of this document, but the requirements and testing methods of this document can be used as a reference.
Note 2: The safety requirements for MRI equipment are specified in IEC 60601-2-33.
Note 3: The principle explanations of the provisions of this document are provided in Appendix A.