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YY/T 1935-2024: Requirements and test methods for safety of implantable pacemakers and cardioverter defibrillators exposed to magnetic resonance imaging
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| YY/T 1935-2024 | English | 2369 |
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Requirements and test methods for safety of implantable pacemakers and cardioverter defibrillators exposed to magnetic resonance imaging
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YY/T 1935-2024
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Basic data | Standard ID | YY/T 1935-2024 (YY/T1935-2024) | | Description (Translated English) | Requirements and test methods for safety of implantable pacemakers and cardioverter defibrillators exposed to magnetic resonance imaging | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 118,166 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Issuing agency(ies) | State Drug Administration | YY/T 1935-2024: Requirements and test methods for safety of implantable pacemakers and cardioverter defibrillators exposed to magnetic resonance imaging
---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.040.40
CCSC35
Pharmaceutical Industry Standards of the People's Republic of China
Implantable cardiac pacemakers and heart rhythm in a magnetic resonance environment
Safety requirements and test methods for cardioverter defibrillators
Released on 2024-07-08
2025-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 1
4 Symbols and abbreviations 4
5 Basic requirements for non-implanted parts 5
6 General testing requirements for device failure 5
7 General notes on the application of the tests in this document 7
8 Radiofrequency heating of electrode leads 7
9 Temperature rise of pulse generator 12
10 Gradient-induced vibrations 14
11 Magneto-displacement force 15
12 Magnetic torque 16
13 Gradient field induced electrode wire voltage 17
14 Static magnetic field causes equipment failure 28
15 RF-Induced Faults and RF Rectification 29
16 Gradient field induced failure 36
17 Combined Field Test 43
Appendix A (Informative) Principle Description 49
Appendix B (Informative) Electrode Conductor Electromagnetic Modeling Method 60
Appendix C (Informative) Physiological Reactions Associated with Radiofrequency Heating 62
Appendix D (Normative) Supplementary requirements and test cases for gradient field related tests 70
Appendix E (Informative) Increase in body temperature with applied heat flux 88
Appendix G (Normative) Radiofrequency Accidental Cardiac Stimulation Compliance Standard 93
Appendix H (Informative) Implementation Example of Combined Field Magnetic Resonance Scanning Scheme 97
Appendix I (Informative) In animal experiments, standard production electrode leads were used to deliver 64 MHz target radiofrequency power to the myocardium.
Appendix J (Informative) Radiofrequency injection method using standard electrode leads 106
References 109
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document was prepared by the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices, Active Implants Subcommittee (SAC/TC110/
SC4) is responsible for the following.
This document was drafted by. Shanghai Institute of Medical Device Inspection, National Medical Products Administration Medical Device Technical Evaluation Center, Fudan University
University, Lepu Medical Electronics Instrument Co., Ltd., Chuangling Cardiac Rhythm Management Medical Devices (Shanghai) Co., Ltd., Suzhou Wushuang Medical Equipment Co., Ltd.
Limited company.
The main drafters of this document are. Hu Sheng, Li Yonghua, Li Chengling, Liu Xun, Chen Ya, Yang Pengfei, Wang Jing, Wu Xiaomei, Jin Hua, Wang Yulin, Ping Lichuan.
Implantable cardiac pacemakers and heart rhythm in a magnetic resonance environment
Safety requirements and test methods for cardioverter defibrillators
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.
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