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

1 Scope

This document specifies 1.5T and 3.0T cylindrical devices for implantable cardiac pacemakers and cardioverter defibrillators operating with whole body coil excitation.

Safety requirements for whole-body magnetic resonance equipment with round (circular or elliptical cross-section) scanning bores and the corresponding test methods are described.

This document applies to implantable cardiac pacemakers and cardioverter defibrillators that meet the following conditions.

--- Systems that do not use sensing functions or are programmed not to use sensing functions during MRI scans;

---Systems that disable high voltage therapy during MRI scans;

---Device implanted in the patient's chest area.

This document does not apply to non-implanted parts of active implantable medical devices.

Note 1.Subcutaneous ICD systems, leadless pacemakers and implantable ECG recorders are not within the scope of this document, but the requirements and tests of this document are

The test method can be used as a reference.

NOTE 2 Safety requirements for magnetic resonance equipment are given in IEC 60601-2-33.

Note 3.See Appendix A for a rationale for the provisions of this document.

2 Normative references

The contents of the following documents constitute essential clauses of this document through normative references in this document.

For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to

This document.

YY/T 0491-2004 Cardiac pacemakers Small cross-section connectors for implantable cardiac pacemakers (ISO 5841-3.2000, IDT)

YY/T 0946-2014 Cardiac Defibrillator DF-1 connector assembly dimensions and test requirements for implantable cardioverter defibrillators (ISO 11318.2002,MOD)

ISO /T S10974.2018 Safety assessment of magnetic resonance imaging of patients with active implantable medical devices

ASTM F2052 Standard Test Method for Measurement of Magneto-Displacement Force on Medical Devices in a Magnetic Resonance Environment ment)

ASTM F2182 Standard test method for measuring radiofrequency heating on or near passive implants during magnetic resonance imaging

3 Terms and definitions

The following terms and definitions apply to this document.