ISO 14117:2019
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
This document specifies test methodologies for the evaluation of the electromagnetic compatibility (EMC) of active implantable cardiovascular devices that provide one or more therapies for bradycardia, tachycardia and cardiac resynchronization in conjunction with transvenous lead systems.
NOTE This document was designed for pulse generators used with endocardial leads or epicardial leads. At the time of this edition, the authors recognized the emergence of technologies that do not use endocardial leads or epicardial leads for which adaptations of this part will be required. Such adaptations are left to the discretion of manufacturers incorporating these technologies.
It specifies performance limits of these devices, which are subject to interactions with EM emitters operating across the EM spectrum in the two following ranges:
— 0 Hz ≤ ? < 385 MHz;
— 385 MHz ≤ ? ≤ 3 000 MHz
This document also specifies requirements for the protection of these devices from EM fields encountered in a therapeutic environment and defines their required accompanying documentation, providing manufacturers of EM emitters with information about their expected level of immunity.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
3.2 Acronyms and abbreviations
4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz
4.1 General requirements for all devices
4.2 Induced lead current
4.2.1 General requirements
4.2.2 Pacemakers and CRT-P devices
4.2.3 ICDs and CRT-D devices
4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields
4.3.1 General requirements
4.3.2 Pacemaker and CRT-P devices
4.3.3 ICDs and CRT-D devices
4.4 Protection from malfunction caused by temporary exposure to CW sources
4.4.1 Pacemaker and CRT-P device' response to temporary continuous wave sources in the frequency range 16,6 Hz to 167 kHz
4.4.2 ICDs and CRT-D devices
4.5 Protection from sensing EMI as cardiac signals
4.5.1 General requirements
4.5.2 Protection from sensing EMI as cardiac signals in the frequency range of 16,6 Hz to 150 kHz
4.5.3 Protection from sensing EMI as cardiac signals in the frequency range of 150 kHz to 10 MHz
4.5.4 Protection from sensing EMI as cardiac signals in the frequency range of 10 MHz to 385 MHz
4.6 Protection from static magnetic fields of flux density up to 1 mT
4.6.1 General requirements
4.6.2 Pacemakers and CRT-P devices
4.6.3 ICDs and CRT-D devices
4.7 Protection from static magnetic fields of flux density up to 50 mT
4.7.1 General requirements
4.7.2 Pacemakers and CRT-P devices
4.7.3 ICDs and CRT-D devices
4.8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz
4.8.1 General requirements
4.8.2 Pacemakers and CRT-P devices
4.8.3 ICDs and CRT-D devices
4.9 Test requirements for the frequency range of 385 MHz ≤ ƒ ≤ 3 000 MHz
4.9.1 General requirements
4.9.2 Test setup
4.9.3 Test procedure
4.9.4 Performance criteria
4.10 Transient exposure to stationary low-frequency electromagnetic field sources in the frequency range 16,6 Hz to 167 kHz
5 Testing above frequency of 3 000 MHz
6 Protection of devices from EM fields encountered in a therapeutic environment
6.1 Protection of the device from damage caused by high-frequency surgical exposure
6.1.1 General requirements
6.1.2 Pacemakers and CRT-P devices
6.1.3 ICDs and CRT-D devices
6.2 Protection of the device from damage caused by external defibrillators
6.2.1 General requirements
6.2.2 Pacemakers and CRT-P devices
6.2.3 ICDs and CRT-D devices
7 Additional accompanying documentation
7.1 Disclosure of permanently programmable sensitivity settings
7.2 Descriptions of reversion modes
7.3 Known potential hazardous behaviour
7.4 Minimum separation distance from hand-held transmitters
Annex A (informative) Rationale
Annex B (informative) Rationale for test frequency ranges
Annex C (informative) Code for describing modes of implantable generators
Annex D (normative) Interface circuits
Annex E (informative) Selection of capacitor Cx
Annex F (normative) Calibration of the injection network (Figure D.5)
Annex G (normative) Torso simulator
Annex H (normative) Dipole antennas
Annex I (normative) Pacemaker/ICD programming settings
Annex J (normative) Simulated cardiac signal
Annex K (normative) Calculation of net power into dipole antenna
Annex L (informative) Loop area calculations
Annex M (informative) Correlation between levels of test voltages used in this document and strengths of radiated fields
Annex N (informative) Connections to DUTs having ports with more than two electrode connections
Annex O (informative) Example method for evaluation of transient and permanent malfunction of a CIED due to temporary exposure to low frequency (167 kHz) electromagnetic fields
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
3.2 Acronyms and abbreviations
4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz
4.1 General requirements for all devices
4.2 Induced lead current
4.2.1 General requirements
4.2.2 Pacemakers and CRT-P devices
4.2.3 ICDs and CRT-D devices
4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields
4.3.1 General requirements
4.3.2 Pacemaker and CRT-P devices
4.3.3 ICDs and CRT-D devices
4.4 Protection from malfunction caused by temporary exposure to CW sources
4.4.1 Pacemaker and CRT-P device' response to temporary continuous wave sources in the frequency range 16,6 Hz to 167 kHz
4.4.2 ICDs and CRT-D devices
4.5 Protection from sensing EMI as cardiac signals
4.5.1 General requirements
4.5.2 Protection from sensing EMI as cardiac signals in the frequency range of 16,6 Hz to 150 kHz
4.5.3 Protection from sensing EMI as cardiac signals in the frequency range of 150 kHz to 10 MHz
4.5.4 Protection from sensing EMI as cardiac signals in the frequency range of 10 MHz to 385 MHz
4.6 Protection from static magnetic fields of flux density up to 1 mT
4.6.1 General requirements
4.6.2 Pacemakers and CRT-P devices
4.6.3 ICDs and CRT-D devices
4.7 Protection from static magnetic fields of flux density up to 50 mT
4.7.1 General requirements
4.7.2 Pacemakers and CRT-P devices
4.7.3 ICDs and CRT-D devices
4.8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz
4.8.1 General requirements
4.8.2 Pacemakers and CRT-P devices
4.8.3 ICDs and CRT-D devices
4.9 Test requirements for the frequency range of 385 MHz ≤ ƒ ≤ 3 000 MHz
4.9.1 General requirements
4.9.2 Test setup
4.9.3 Test procedure
4.9.4 Performance criteria
4.10 Transient exposure to stationary low-frequency electromagnetic field sources in the frequency range 16,6 Hz to 167 kHz
5 Testing above frequency of 3 000 MHz
6 Protection of devices from EM fields encountered in a therapeutic environment
6.1 Protection of the device from damage caused by high-frequency surgical exposure
6.1.1 General requirements
6.1.2 Pacemakers and CRT-P devices
6.1.3 ICDs and CRT-D devices
6.2 Protection of the device from damage caused by external defibrillators
6.2.1 General requirements
6.2.2 Pacemakers and CRT-P devices
6.2.3 ICDs and CRT-D devices
7 Additional accompanying documentation
7.1 Disclosure of permanently programmable sensitivity settings
7.2 Descriptions of reversion modes
7.3 Known potential hazardous behaviour
7.4 Minimum separation distance from hand-held transmitters
Annex A (informative) Rationale
Annex B (informative) Rationale for test frequency ranges
Annex C (informative) Code for describing modes of implantable generators
Annex D (normative) Interface circuits
Annex E (informative) Selection of capacitor Cx
Annex F (normative) Calibration of the injection network (Figure D.5)
Annex G (normative) Torso simulator
Annex H (normative) Dipole antennas
Annex I (normative) Pacemaker/ICD programming settings
Annex J (normative) Simulated cardiac signal
Annex K (normative) Calculation of net power into dipole antenna
Annex L (informative) Loop area calculations
Annex M (informative) Correlation between levels of test voltages used in this document and strengths of radiated fields
Annex N (informative) Connections to DUTs having ports with more than two electrode connections
Annex O (informative) Example method for evaluation of transient and permanent malfunction of a CIED due to temporary exposure to low frequency (167 kHz) electromagnetic fields
Bibliography