ISO 14117:2012
Active implantable medical devices — Electromagnetic compatibility — EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
ISO 14117:2012 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.
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 ≤ f < 450 MHz;
450 MHz ≤ f ≤ 3 000 MHz.
ISO 14117:2012 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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CVP_Secretariat_Loca
SameLvl
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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 International Standard and strengths of radiated fields
Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions, symbols and abbreviations
4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz
4.1 General
4.2 Induced lead current
4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields
4.4 Temporary response to continuous wave sources
4.5 Protection from sensing EMI as cardiac signals
4.6 Protection from static magnetic fields of flux density up to 1 mT
4.7 Protection from static magnetic fields of flux density up to 50 mT
4.8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz
4.9 Test requirements for the frequency range of 450 MHz ≤ ƒ ≤ 3 000 MHz
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
6.2 Protection of the device from damage caused by external defibrillators
7 Additional accompanying documentation
7.1 Disclosure of permanently programmable sensitivity settings
7.2 Descriptions of reversion modes
7.3 Known potential hazardous behaviour
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 International Standard and strengths of radiated fields
Bibliography
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CVP_Secretariat_Loca
SameLvl
n
PrevLvl
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 International Standard and strengths of radiated fields
Bibliography
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions, symbols and abbreviations
4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz
4.1 General
4.2 Induced lead current
4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields
4.4 Temporary response to continuous wave sources
4.5 Protection from sensing EMI as cardiac signals
4.6 Protection from static magnetic fields of flux density up to 1 mT
4.7 Protection from static magnetic fields of flux density up to 50 mT
4.8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz
4.9 Test requirements for the frequency range of 450 MHz ≤ ƒ ≤ 3 000 MHz
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
6.2 Protection of the device from damage caused by external defibrillators
7 Additional accompanying documentation
7.1 Disclosure of permanently programmable sensitivity settings
7.2 Descriptions of reversion modes
7.3 Known potential hazardous behaviour
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 International Standard and strengths of radiated fields
Bibliography