AAMI 14117 2019
$162.84
ANSI/AAMI/ ISO 14117:2019 – Active implantable medical devices-Electromagnetic compatibility-EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 152 |
Specifies a comprehensive test methodology for the evaluation of the electromagnetic (EM) compatibility of active implantable cardiovascular devices. The devices addressed by this standard include those that provide one or more therapies for bradycardia, tachycardia, and cardiac resynchronization. This document details test methods appropriate for the interference frequencies at issue. It specifies performance limits or requires disclosure of performance in the presence of EM emitters, where indicated.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 14117:2019; Active implantable medical devicesโElectromagnetic compatibilityโEMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 7 | Background of ANSI/AAMI adoption of ISO 14117:2019 |
| 8 | Foreword |
| 10 | Introduction |
| 13 | 1 Scope 2 Normative references 3 Terms, definitions, symbols and abbreviated terms 3.1 Terms and definitions |
| 15 | 3.2 Acronyms and abbreviations Table 1 โ List of acronyms and abbreviations |
| 17 | 4 Test requirements for the frequency band 0 Hz โค ฦ โค 3 000 MHz 4.1 General requirements for all devices 4.2 Induced lead current 4.2.1 General requirements |
| 18 | 4.2.2 Pacemakers and CRT-P devices Figure 1 โ Test signal 2 |
| 19 | Figure 2 โ Test setup for measurement of induced current |
| 20 | Figure 3 โ Connection to a single-channel unipolar device Figure 4 โ Connection to a multichannel unipolar device Figure 5 โ Common mode connection to single-channel bipolar device |
| 21 | Figure 6 โ Differential mode connection to single-channel bipolar device Figure 7 โ Common mode connection to multichannel bipolar device Figure 8 โ Differential mode connection to multichannel bipolar device |
| 22 | Table 2 โ Spurious injection current limits 4.2.3 ICDs and CRT-D devices 4.2.3.1 Test requirements 4.2.3.2 Measurement of current injected through sense/pace terminals |
| 23 | Figure 9 โ Common mode connection to multichannel bipolar device Figure 10 โ Differential mode connection to multichannel bipolar device 4.2.3.3 Measurement of current injected through cardioversion/defibrillation terminals |
| 24 | Figure 11 โ Common mode connection for cardioversion/defibrillation terminals Figure 12 โ Differential mode connection for cardioversion/defibrillation terminals |
| 25 | Table 3a โ Spurious injection current limits for sense/pace terminals Table 3b โ Spurious injection current limits for cardioversion/defibrillation terminals 4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields 4.3.1 General requirements 4.3.2 Pacemaker and CRT-P devices 4.3.2.1 Malfunction due to electromagnetic interference in the frequency range of 16,6 Hz to 10 MHz |
| 26 | Table 4 โ Peak-to-peak amplitudes Vpp in the range 16,6 Hz to 10 MHz Figure 13 โ Test setup to check for induced malfunction |
| 27 | Figure 14 โ Connection to a single-channel unipolar device Figure 15 โ Connection to a multichannel unipolar device Figure 16 โ Common mode connection to a single-channel bipolar device Figure 17 โ Differential mode connection to a single-channel bipolar device |
| 28 | Figure 18 โ Common mode connection to a multichannel bipolar device Figure 19 โ Differential mode connection to a multichannel bipolar device 4.3.2.2 Malfunction due to electromagnetic interference in the frequency range of 10 MHz to 385 MHz Figure 20 โ Test signal for frequencies between 10 MHz and 385 MHz |
| 29 | Figure 21 โ Test setup to check for malfunction at high frequency |
| 30 | Figure 22 โ Connection to a unipolar device Figure 23 โ Connection to a bipolar device 4.3.2.3 Malfunction due to electromagnetic interference in the frequency range of 385 MHz to 3 000 MHz 4.3.3 ICDs and CRT-D devices 4.3.3.1 Malfunction due to electromagnetic interference in the frequency range of 16,6 Hz to 10 MHz 4.3.3.1.1 Test equipment and signal |
| 31 | Table 5 โ Peak-to-peak amplitudes Vpp in the range 16,6 Hz to 10 MHz 4.3.3.1.2 Malfunction because of electrical interference on the sense or pace terminals |
| 32 | Figure 24 โ Common mode connection for multichannel bipolar devices Figure 25 โ Differential mode connection for multichannel bipolar devices 4.3.3.1.3 Malfunction because of electromagnetic interference on the cardioversion/ defibrillation terminals Figure 26 โ Test setup to check for induced malfunction attributable to voltages induced on cardioversion/defibrillation terminals |
| 33 | Figure 27 โ Common mode connection for cardioversion/defibrillation terminals Figure 28 โ Differential mode connection for cardioversion/defibrillation terminals 4.3.3.2 Malfunction due to electromagnetic interference in the frequency range of 10 MHz to 385 MHz 4.3.3.2.1 Test equipment and signal |
| 34 | Figure 29 โ Test signal for frequencies between 10 MHz and 385 MHz 4.3.3.2.2 Malfunction because of electrical interference on the sense or pace terminals |
| 35 | Figure 30 โ Test set-up to check for induced malfunction at high frequency Figure 31 โ Connection of the DUT |
| 36 | 4.3.3.2.3 Malfunction because of electromagnetic interference on the cardioversion/ defibrillation terminals 4.3.3.3 Malfunction due to electromagnetic interference in the frequency range of 385 MHz to 3 000 MHz 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 |
| 37 | Figure 32 โ Test setup to characterize DUT performance while subject to interference |
| 38 | 4.4.2 ICDs and CRT-D devices |
| 39 | 4.5 Protection from sensing EMI as cardiac signals 4.5.1 General requirements |
| 40 | 4.5.2 Protection from sensing EMI as cardiac signals in the frequency range of 16,6 Hz to 150 kHz 4.5.2.1 Pacemakers and CRT-P devices Table 6 โ Peak-to-peak amplitudes Vpp in the range of 16,6 Hz to 150 kHz |
| 41 | Figure 33 โ Test signal 2: Used in the range of 1 kHz to 150 kHz 4.5.2.2 ICDs and CRT-D devices |
| 42 | Table 7โ Peak-to-peak amplitudes Vpp in the range of 16,6 Hz to 150 kHz Figure 34 โ Test signal 2: Used in the range of 1 kHz to 150 kHz |
| 44 | 4.5.3 Protection from sensing EMI as cardiac signals in the frequency range of 150 kHz to 10 MHz 4.5.3.1 Pacemakers and CRT-P devices Figure 35 โ Test signal for frequencies 150 kHz to 10 MHz Table 8 โ Peak-to-peak test signal amplitudes Vpp in the range of 150 kHz to 10 MHz |
| 45 | 4.5.3.2 ICDs and CRT-D devices Table 9 โ Peak-to-peak test signal amplitudes Vpp in the range of 150 kHz to 10 MHz Figure 36 โ Test signal for frequencies 150 kHz to 10 MHz |
| 47 | 4.5.4 Protection from sensing EMI as cardiac signals in the frequency range of 10 MHz to 385 MHz 4.5.4.1 Pacemakers and CRT-P devices |
| 48 | Figure 37 โ Test setup to check for malfunction at high frequency |
| 49 | Figure 38 โ Connection to a unipolar device 4.5.4.2 ICDs and CRT-D devices 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 |
| 50 | Figure 40 โ Test setup for magnetostatic measurements 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 |
| 51 | 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 Table 10 โ Sinusoidally modulated magnetic field strengths |
| 52 | Figure 41 โ Loop configuration for varying magnetic field test 4.8.3 ICDs and CRT-D devices 4.9 Test requirements for the frequency range of 385 MHz โค ฦ โค 3 000 MHz 4.9.1 General requirements |
| 53 | 4.9.2 Test setup 4.9.2.1 Test environment 4.9.2.2 Torso simulator in Annex G Table 11 โ Requirements for the test setup 4.9.2.3 Device under test and lead positioning in torso simulator 4.9.2.4 Interference signal generation |
| 54 | 4.9.2.5 Parameter programming 4.9.2.6 Monitoring of device activity 4.9.2.7 Simulated cardiac signal injection 4.9.3 Test procedure 4.9.3.1 Protection from proximity fields at 15 cm separation distance |
| 56 | 4.9.3.2 Optional characterization testing 4.9.4 Performance criteria 4.9.4.1 Single-chamber pacing modes 4.9.4.2 Multi-chamber pacing modes |
| 57 | 4.9.4.3 Antitachyarrhythmia modes 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 |
| 58 | 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 Figure 42 โ Test setup for protection of the device from high-frequency currents caused by high-frequency surgical equipment |
| 59 | Table 12 โ Test signal characteristics 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 |
| 60 | Figure 43 โ Damped sinus waveform Figure 44 โ Circuit for generating a damped sinus defibrillation waveform for Test 1 |
| 61 | Figure 45 โ Timing sequence used in Tests 1 and 2 |
| 62 | Figure 46 โ Test setup for Test 2 (using a truncated exponential defibrillation waveform) Figure 47 โ Resistor network for Tests 1 and 2 Table 13 โ Resistor network parameters |
| 63 | Figure 48 โ Biphasic defibrillation waveform for Test 2 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 |
| 64 | Annex A (informative) Rationale A.1 Rationale for test requirements for the frequency band 0 Hz โค ฦ < 385 MHz (see 4.1 to 4.8) |
| 69 | Figure A.1 โ Maximum allowed current when injected to the heart |
| 72 | A.2 Rationale for test requirements for the frequency band 385 MHz โค ฦ โค 3 000 MHz (see 4.9) A.2.1 Rationale for DUT reference point A.2.2 Rationale for the RF modulation A.2.3 Rationale for the optional characterization testing A.2.4 Rationale for test power levels |
| 73 | Figure A.2 โ Dipole net power measurements (dipole spacing = 2,5 cm) conducted for ANSI/AAMI PC69:2000 |
| 74 | A.2.5 Rationale for lead configuration A.2.6 Rationale for device programmed parameters |
| 75 | A.3 Rationale for sample size A.4 Rationale for test requirements in Clause 6 A.4.1 Protection of the device from damage caused by high-frequency surgical exposure A.4.2 Protection of the device from damage caused by external defibrillators |
| 76 | A.4.3 Test signal modulation format |
| 77 | Annex B (informative) Rationale for test frequency ranges |
| 78 | Annex C (informative) Code for describing modes of implantable generators C.1 The code Table C.1 โ NASPE/BPEG generic (NBG) pacemaker code |
| 79 | Table C.2 โ NASPE/BPEG defibrillator (NBD) code |
| 80 | Annex D (normative) Interface circuits Figure D.1 โ Tissue-equivalent interface circuit for current measurements Table D.1 a) Component values for Figure D.1 |
| 81 | Table D.1 b) Component values for Figure D.1 Figure D.2 โ Tissue-equivalent interface circuit to check for malfunction |
| 82 | Table D.2 โ Component values for Figure D.2 Figure D.3 โ Tissue-equivalent interface circuit to check for malfunction caused by voltages induced on cardioversion/defibrillation terminals |
| 83 | Table D.3 โ Component values for Figure D.3 Figure D.4 โ Low-pass filter used to attenuate the 500 kHz component of a test signal (see 4.2.2, 4.2.3, and Annex E) Table D.4 โ Component values for Figure D.4 |
| 84 | Figure D.5 โ Injection network Table D.5 โ Component values for Figure D.5 |
| 86 | Annex E (informative) Selection of capacitor Cx |
| 87 | Figure E.1 โ Example amplitude at point D and C of the tissue-equivalent interface (CX selected for 5 000 Hz corner frequency) |
| 88 | Figure E.2 โ Test to check for spurious low-frequency noise and to determine the value of Cx |
| 89 | Annex F (normative) Calibration of the injection network (Figure D.5) |
| 90 | Table F.1 โ Calibration signal amplitude |
| 91 | Annex G (normative) Torso simulator G.1 Torso simulator G.2 Top grid G.3 Cutout G.4 Bottom grid G.5 Torso simulator electrodes |
| 92 | G.6 Illustrations |
| 93 | Figure G.1 โ Torso simulator |
| 94 | Figure G.2 โ Test setup |
| 95 | Annex H (normative) Dipole antennas H.1 Resonant dipole Table H.1 โ Dipole description |
| 96 | Figure H.1 โ Example of a dipole antenna |
| 97 | Annex I (normative) Pacemaker/ICD programming settings I.1 General I.2 Pacemaker I.2.1 Parameters Table I.1 โ Pacemaker parameters I.2.2 Diagnostic settings |
| 98 | I.3 ICD I.3.1 Parameters Table I.2 โ Tachycardia device parameters I.3.2 Diagnostic settings |
| 99 | I.4 Other operating modes or parameters not implied in this document |
| 100 | Annex J (normative) Simulated cardiac signal J.1 Heart simulated signal Figure J.1 โ Simulated cardiac signal |
| 101 | Annex K (normative) Calculation of net power into dipole antenna K.1 Calculation of net dipole power K.1.1 Calculation of forward dipole power (dBm) K.1.2 Conversion of forward dipole power from dBm to milliwatts K.1.3 Calculation of reflected dipole power (dBm) |
| 102 | K.1.4 Conversion of reflected dipole power from dBm to milliwatts K.1.5 Calculation of net dipole power (mW) K.2 Measurement of factors for net power calculations K.2.1 DCF โ Directional coupler forward port coupling factor K.2.2 DCR โ Directional coupler reflected port coupling factor |
| 103 | K.2.3 ACA antenna cable attenuation |
| 106 | Annex L (informative) Loop area calculations L.1 Purpose L.2 Procedure |
| 107 | Figure L.1 โ Simulated right pectoral dual-chamber pacemaker X-ray |
| 108 | Figure L.2 โ Simulated left pectoral dual-chamber ICD X-ray L.3 Results |
| 109 | Table L.1 โ Pacemaker systems |
| 110 | Table L.2 โ ICD systems |
| 111 | L.4 Summary โ Geometrical lead loop area L.5 Effective induction area |
| 112 | Figure L.3 โ Effective induction area of an open wire loop inside a conductive medium L.6 Consideration of Lead Loop Area based on CRT-P/CRT-D devices and Left Ventricular lead placement |
| 113 | Annex M (informative) Correlation between levels of test voltages used in this document and strengths of radiated fields |
| 117 | Figure M.1 โ Comparison of induced voltages resulting from ICNIRP and IEEE H-field general public reference levels and the test limits of this document |
| 118 | Figure M.2 โ Comparison of magnetic field general public reference exposure values from ICNIRP and IEEE with equivalent magnetic field immunity from ISO 14117 |
| 119 | Figure M.3 โ Induced voltage zones |
| 120 | Figure M.4 โ Magnetic field zones |
| 121 | Annex N (informative) Connections to DUTs having ports with more than two electrode connections N.1 Introduction N.2 New nomenclature of ports and electrodes |
| 122 | Figure N.1 โ Schematic representation of ports and electrodes for a generic multi-port multi-polar device; the order of the ports, and electrodes in each port shown in the picture is arbitrary |
| 123 | N.3 Examples of application of the nomenclature to typical DUTs Figure N.2 โ Example of DR pacemaker device according to the new nomenclature |
| 125 | Figure N.3 โ Example of DF-1 CRT-D device according to the new nomenclature |
| 127 | Figure N.4 โ Example of DF-4 IS-4 CRT-D device according to the new nomenclature N.4 Generalization of tissue-equivalent circuit and test setup N.4.1 Nomenclature |
| 128 | Figure N.5 a) Tissue-equivalent interface extension to multi-port multi-polar devices. Fp,e indicates a network output paired to the low-voltage electrode โeโ of device port โpโ |
| 130 | N.4.2 Unipolar Injection Configuration โ Tests 4.3/4.4/4.5 (up to 10 MHz) Figure N.6 โ Extension of Unipolar Injection Configuration for multi-port multi-polar devices- applicable to tests 4.3/4.4/4.5 (up to 10 MHz) |
| 131 | Figure N.7 โ Extension of Unipolar Injection Configuration for multi-port multi-polar devices. Example of a DR pacemaker Figure N.8 โ Extension of Unipolar Injection Configuration for multi-port multi-polar devices. Example of a DF-1 CRT-D |
| 132 | Figure N.9 โ Extension of Unipolar Injection Configuration for multi-port multi-polar devices. Example of a DF-4 IS-4 CRT-D |
| 133 | N.5 Multipolar Common Mode Injection Configuration โ Tests 4.3/4.4/4.5 (up to 10 MHz) Figure N.10 โ Extension of Multipolar Common Mode Injection Configuration for multi-port multi-polar devices- applicable to tests 4.3/4.4/4.5 (up to 10 MHz) |
| 134 | Figure N.11 โ Extension of Multipolar Common Mode Injection Configuration for multi-port multi-polar devices. Example of a DR pacemaker |
| 135 | Figure N.12 โ Extension of Multipolar Common Mode Injection Configuration for multi-port multi-polar devices. Example of a DF-1 CRT-D |
| 136 | Figure N.13 โ Extension of Multipolar Common Mode Injection Configuration for multi-port multi-polar devices. Example of a DF-4 IS-4 CRT-D |
| 137 | N.6 Multipolar Differential Mode Injection Configuration โ Tests 4.3/4.4/4.5 (up to 10 MHz) Figure N.14 โ Extension of Bipolar Differential Mode Injection Configuration for multi-port multi-polar devices- applicable to tests 4.3/4.4/4.5 (up to 10 MHz) |
| 138 | Figure N.15 โ Extension of Bipolar Differential Mode Injection Configuration for multi-port multi-polar devices. Example of a DR pacemaker |
| 140 | Figure N.16 โ Extension of Bipolar Differential Mode Injection Configuration for multi-port multi-polar devices. Example of a DF-1 CRT-D |
| 143 | Figure N.17 โ Extension of Bipolar Differential Mode Injection Configuration for multi-port multi-polar devices. Example of a DF-4 IS-4 CRT-D |
| 145 | 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 O.1 General considerations O.2 Pacemakers and CRT-P devices |
| 146 | Figure O.1 โ Test signal 1: CW exposure |
| 147 | Figure O.2 โ Test signal 2: Burst-modulated exposure (for illustration purposes modulation parameters B and T are not scaled) |
| 148 | O.3 ICDs and CRT-D devices O.4 Rationale for test signal modulation |
| 149 | Figure O.3 โ Biot-Savart law for a circular current loop emitter; Bz is the B-field component along the z-axis perpendicular to the current loop |
| 150 | Bibliography |
