{"id":198329,"date":"2024-10-19T12:37:32","date_gmt":"2024-10-19T12:37:32","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-14117-2019\/"},"modified":"2024-10-25T05:10:37","modified_gmt":"2024-10-25T05:10:37","slug":"aami-14117-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-14117-2019\/","title":{"rendered":"AAMI 14117 2019"},"content":{"rendered":"

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.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 14117:2019; Active implantable medical devices\u2014Electromagnetic compatibility\u2014EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
7<\/td>\nBackground of ANSI\/AAMI adoption of ISO 14117:2019 <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n3.2 Acronyms and abbreviations
Table 1 \u2014 List of acronyms and abbreviations <\/td>\n<\/tr>\n
17<\/td>\n4 Test requirements for the frequency band 0 Hz \u2264 \u0192 \u2264 3 000 MHz
4.1 General requirements for all devices
4.2 Induced lead current
4.2.1 General requirements <\/td>\n<\/tr>\n
18<\/td>\n4.2.2 Pacemakers and CRT-P devices
Figure 1 \u2014 Test signal 2 <\/td>\n<\/tr>\n
19<\/td>\nFigure 2 \u2014 Test setup for measurement of induced current <\/td>\n<\/tr>\n
20<\/td>\nFigure 3 \u2014 Connection to a single-channel unipolar device
Figure 4 \u2014 Connection to a multichannel unipolar device
Figure 5 \u2014 Common mode connection to single-channel bipolar device <\/td>\n<\/tr>\n
21<\/td>\nFigure 6 \u2014 Differential mode connection to single-channel bipolar device
Figure 7 \u2014 Common mode connection to multichannel bipolar device
Figure 8 \u2014 Differential mode connection to multichannel bipolar device <\/td>\n<\/tr>\n
22<\/td>\nTable 2 \u2014 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 <\/td>\n<\/tr>\n
23<\/td>\nFigure 9 \u2014 Common mode connection to multichannel bipolar device
Figure 10 \u2014 Differential mode connection to multichannel bipolar device
4.2.3.3 Measurement of current injected through cardioversion\/defibrillation terminals <\/td>\n<\/tr>\n
24<\/td>\nFigure 11 \u2014 Common mode connection for cardioversion\/defibrillation terminals
Figure 12 \u2014 Differential mode connection for cardioversion\/defibrillation terminals <\/td>\n<\/tr>\n
25<\/td>\nTable 3a \u2014 Spurious injection current limits for sense\/pace terminals
Table 3b \u2014 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 <\/td>\n<\/tr>\n
26<\/td>\nTable 4 \u2014 Peak-to-peak amplitudes Vpp in the range 16,6 Hz to 10 MHz
Figure 13 \u2014 Test setup to check for induced malfunction <\/td>\n<\/tr>\n
27<\/td>\nFigure 14 \u2014 Connection to a single-channel unipolar device
Figure 15 \u2014 Connection to a multichannel unipolar device
Figure 16 \u2014 Common mode connection to a single-channel bipolar device
Figure 17 \u2014 Differential mode connection to a single-channel bipolar device <\/td>\n<\/tr>\n
28<\/td>\nFigure 18 \u2014 Common mode connection to a multichannel bipolar device
Figure 19 \u2014 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 \u2014 Test signal for frequencies between 10 MHz and 385 MHz <\/td>\n<\/tr>\n
29<\/td>\nFigure 21 \u2014 Test setup to check for malfunction at high frequency <\/td>\n<\/tr>\n
30<\/td>\nFigure 22 \u2014 Connection to a unipolar device
Figure 23 \u2014 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 <\/td>\n<\/tr>\n
31<\/td>\nTable 5 \u2014 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 <\/td>\n<\/tr>\n
32<\/td>\nFigure 24 \u2014 Common mode connection for multichannel bipolar devices
Figure 25 \u2014 Differential mode connection for multichannel bipolar devices
4.3.3.1.3 Malfunction because of electromagnetic interference on the cardioversion\/ defibrillation terminals
Figure 26 \u2014 Test setup to check for induced malfunction attributable to voltages induced on cardioversion\/defibrillation terminals <\/td>\n<\/tr>\n
33<\/td>\nFigure 27 \u2014 Common mode connection for cardioversion\/defibrillation terminals
Figure 28 \u2014 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 <\/td>\n<\/tr>\n
34<\/td>\nFigure 29 \u2014 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 <\/td>\n<\/tr>\n
35<\/td>\nFigure 30 \u2014 Test set-up to check for induced malfunction at high frequency
Figure 31 \u2014 Connection of the DUT <\/td>\n<\/tr>\n
36<\/td>\n4.3.3.2.3 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 <\/td>\n<\/tr>\n
37<\/td>\nFigure 32 \u2014 Test setup to characterize DUT performance while subject to interference <\/td>\n<\/tr>\n
38<\/td>\n4.4.2 ICDs and CRT-D devices <\/td>\n<\/tr>\n
39<\/td>\n4.5 Protection from sensing EMI as cardiac signals
4.5.1 General requirements <\/td>\n<\/tr>\n
40<\/td>\n4.5.2 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 \u2014 Peak-to-peak amplitudes Vpp in the range of 16,6 Hz to 150 kHz <\/td>\n<\/tr>\n
41<\/td>\nFigure 33 \u2014 Test signal 2: Used in the range of 1 kHz to 150 kHz
4.5.2.2 ICDs and CRT-D devices <\/td>\n<\/tr>\n
42<\/td>\nTable 7\u2014 Peak-to-peak amplitudes Vpp in the range of 16,6 Hz to 150 kHz
Figure 34 \u2014 Test signal 2: Used in the range of 1 kHz to 150 kHz <\/td>\n<\/tr>\n
44<\/td>\n4.5.3 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 \u2014 Test signal for frequencies 150 kHz to 10 MHz
Table 8 \u2014 Peak-to-peak test signal amplitudes Vpp in the range of 150 kHz to 10 MHz <\/td>\n<\/tr>\n
45<\/td>\n4.5.3.2 ICDs and CRT-D devices
Table 9 \u2014 Peak-to-peak test signal amplitudes Vpp in the range of 150 kHz to 10 MHz
Figure 36 \u2014 Test signal for frequencies 150 kHz to 10 MHz <\/td>\n<\/tr>\n
47<\/td>\n4.5.4 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 <\/td>\n<\/tr>\n
48<\/td>\nFigure 37 \u2014 Test setup to check for malfunction at high frequency <\/td>\n<\/tr>\n
49<\/td>\nFigure 38 \u2014 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 <\/td>\n<\/tr>\n
50<\/td>\nFigure 40 \u2014 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 <\/td>\n<\/tr>\n
51<\/td>\n4.7.2 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 \u2014 Sinusoidally modulated magnetic field strengths <\/td>\n<\/tr>\n
52<\/td>\nFigure 41 \u2014 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 \u2264 \u0192 \u2264 3 000 MHz
4.9.1 General requirements <\/td>\n<\/tr>\n
53<\/td>\n4.9.2 Test setup
4.9.2.1 Test environment
4.9.2.2 Torso simulator in Annex G
Table 11 \u2014 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 <\/td>\n<\/tr>\n
54<\/td>\n4.9.2.5 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 <\/td>\n<\/tr>\n
56<\/td>\n4.9.3.2 Optional characterization testing
4.9.4 Performance criteria
4.9.4.1 Single-chamber pacing modes
4.9.4.2 Multi-chamber pacing modes <\/td>\n<\/tr>\n
57<\/td>\n4.9.4.3 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 <\/td>\n<\/tr>\n
58<\/td>\n6 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 \u2014 Test setup for protection of the device from high-frequency currents caused by high-frequency surgical equipment <\/td>\n<\/tr>\n
59<\/td>\nTable 12 \u2014 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 <\/td>\n<\/tr>\n
60<\/td>\nFigure 43 \u2014 Damped sinus waveform
Figure 44 \u2014 Circuit for generating a damped sinus defibrillation waveform for Test 1 <\/td>\n<\/tr>\n
61<\/td>\nFigure 45 \u2014 Timing sequence used in Tests 1 and 2 <\/td>\n<\/tr>\n
62<\/td>\nFigure 46 \u2014 Test setup for Test 2 (using a truncated exponential defibrillation waveform)
Figure 47 \u2014 Resistor network for Tests 1 and 2
Table 13 \u2014 Resistor network parameters <\/td>\n<\/tr>\n
63<\/td>\nFigure 48 \u2014 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 <\/td>\n<\/tr>\n
64<\/td>\nAnnex A (informative) Rationale
A.1 Rationale for test requirements for the frequency band 0 Hz \u2264 \u0192 < 385 MHz (see 4.1 to 4.8) <\/td>\n<\/tr>\n
69<\/td>\nFigure A.1 \u2014 Maximum allowed current when injected to the heart <\/td>\n<\/tr>\n
72<\/td>\nA.2 Rationale for test requirements for the frequency band 385 MHz \u2264 \u0192 \u2264 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 <\/td>\n<\/tr>\n
73<\/td>\nFigure A.2 \u2014 Dipole net power measurements (dipole spacing = 2,5 cm) conducted for ANSI\/AAMI PC69:2000 <\/td>\n<\/tr>\n
74<\/td>\nA.2.5 Rationale for lead configuration
A.2.6 Rationale for device programmed parameters <\/td>\n<\/tr>\n
75<\/td>\nA.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 <\/td>\n<\/tr>\n
76<\/td>\nA.4.3 Test signal modulation format <\/td>\n<\/tr>\n
77<\/td>\nAnnex B (informative) Rationale for test frequency ranges <\/td>\n<\/tr>\n
78<\/td>\nAnnex C (informative) Code for describing modes of implantable generators
C.1 The code
Table C.1 \u2014 NASPE\/BPEG generic (NBG) pacemaker code <\/td>\n<\/tr>\n
79<\/td>\nTable C.2 \u2014 NASPE\/BPEG defibrillator (NBD) code <\/td>\n<\/tr>\n
80<\/td>\nAnnex D (normative) Interface circuits
Figure D.1 \u2014 Tissue-equivalent interface circuit for current measurements
Table D.1 a) Component values for Figure D.1 <\/td>\n<\/tr>\n
81<\/td>\nTable D.1 b) Component values for Figure D.1
Figure D.2 \u2014 Tissue-equivalent interface circuit to check for malfunction <\/td>\n<\/tr>\n
82<\/td>\nTable D.2 \u2014 Component values for Figure D.2
Figure D.3 \u2014 Tissue-equivalent interface circuit to check for malfunction caused by voltages induced on cardioversion\/defibrillation terminals <\/td>\n<\/tr>\n
83<\/td>\nTable D.3 \u2014 Component values for Figure D.3
Figure D.4 \u2014 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 \u2014 Component values for Figure D.4 <\/td>\n<\/tr>\n
84<\/td>\nFigure D.5 \u2014 Injection network
Table D.5 \u2014 Component values for Figure D.5 <\/td>\n<\/tr>\n
86<\/td>\nAnnex E (informative) Selection of capacitor Cx <\/td>\n<\/tr>\n
87<\/td>\nFigure E.1 \u2014 Example amplitude at point D and C of the tissue-equivalent interface (CX selected for 5 000 Hz corner frequency) <\/td>\n<\/tr>\n
88<\/td>\nFigure E.2 \u2014 Test to check for spurious low-frequency noise and to determine the value of Cx <\/td>\n<\/tr>\n
89<\/td>\nAnnex F (normative) Calibration of the injection network (Figure D.5) <\/td>\n<\/tr>\n
90<\/td>\nTable F.1 \u2014 Calibration signal amplitude <\/td>\n<\/tr>\n
91<\/td>\nAnnex G (normative) Torso simulator
G.1 Torso simulator
G.2 Top grid
G.3 Cutout
G.4 Bottom grid
G.5 Torso simulator electrodes <\/td>\n<\/tr>\n
92<\/td>\nG.6 Illustrations <\/td>\n<\/tr>\n
93<\/td>\nFigure G.1 \u2014 Torso simulator <\/td>\n<\/tr>\n
94<\/td>\nFigure G.2 \u2014 Test setup <\/td>\n<\/tr>\n
95<\/td>\nAnnex H (normative) Dipole antennas
H.1 Resonant dipole
Table H.1 \u2014 Dipole description <\/td>\n<\/tr>\n
96<\/td>\nFigure H.1 \u2014 Example of a dipole antenna <\/td>\n<\/tr>\n
97<\/td>\nAnnex I (normative) Pacemaker\/ICD programming settings
I.1 General
I.2 Pacemaker
I.2.1 Parameters
Table I.1 \u2014 Pacemaker parameters
I.2.2 Diagnostic settings <\/td>\n<\/tr>\n
98<\/td>\nI.3 ICD
I.3.1 Parameters
Table I.2 \u2014 Tachycardia device parameters
I.3.2 Diagnostic settings <\/td>\n<\/tr>\n
99<\/td>\nI.4 Other operating modes or parameters not implied in this document <\/td>\n<\/tr>\n
100<\/td>\nAnnex J (normative) Simulated cardiac signal
J.1 Heart simulated signal
Figure J.1 \u2014 Simulated cardiac signal <\/td>\n<\/tr>\n
101<\/td>\nAnnex 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) <\/td>\n<\/tr>\n
102<\/td>\nK.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 \u2014 Directional coupler forward port coupling factor
K.2.2 DCR \u2014 Directional coupler reflected port coupling factor <\/td>\n<\/tr>\n
103<\/td>\nK.2.3 ACA antenna cable attenuation <\/td>\n<\/tr>\n
106<\/td>\nAnnex L (informative) Loop area calculations
L.1 Purpose
L.2 Procedure <\/td>\n<\/tr>\n
107<\/td>\nFigure L.1 \u2014 Simulated right pectoral dual-chamber pacemaker X-ray <\/td>\n<\/tr>\n
108<\/td>\nFigure L.2 \u2014 Simulated left pectoral dual-chamber ICD X-ray
L.3 Results <\/td>\n<\/tr>\n
109<\/td>\nTable L.1 \u2014 Pacemaker systems <\/td>\n<\/tr>\n
110<\/td>\nTable L.2 \u2014 ICD systems <\/td>\n<\/tr>\n
111<\/td>\nL.4 Summary \u2014 Geometrical lead loop area
L.5 Effective induction area <\/td>\n<\/tr>\n
112<\/td>\nFigure L.3 \u2014 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 <\/td>\n<\/tr>\n
113<\/td>\nAnnex M (informative) Correlation between levels of test voltages used in this document and strengths of radiated fields <\/td>\n<\/tr>\n
117<\/td>\nFigure M.1 \u2014 Comparison of induced voltages resulting from ICNIRP and IEEE H-field general public reference levels and the test limits of this document <\/td>\n<\/tr>\n
118<\/td>\nFigure M.2 \u2014 Comparison of magnetic field general public reference exposure values from ICNIRP and IEEE with equivalent magnetic field immunity from ISO 14117 <\/td>\n<\/tr>\n
119<\/td>\nFigure M.3 \u2014 Induced voltage zones <\/td>\n<\/tr>\n
120<\/td>\nFigure M.4 \u2014 Magnetic field zones <\/td>\n<\/tr>\n
121<\/td>\nAnnex N (informative) Connections to DUTs having ports with more than two electrode connections
N.1 Introduction
N.2 New nomenclature of ports and electrodes <\/td>\n<\/tr>\n
122<\/td>\nFigure N.1 \u2014 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 <\/td>\n<\/tr>\n
123<\/td>\nN.3 Examples of application of the nomenclature to typical DUTs
Figure N.2 \u2014 Example of DR pacemaker device according to the new nomenclature <\/td>\n<\/tr>\n
125<\/td>\nFigure N.3 \u2014 Example of DF-1 CRT-D device according to the new nomenclature <\/td>\n<\/tr>\n
127<\/td>\nFigure N.4 \u2014 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 <\/td>\n<\/tr>\n
128<\/td>\nFigure 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 \u2018e\u2019 of device port \u2018p\u2019 <\/td>\n<\/tr>\n
130<\/td>\nN.4.2 Unipolar Injection Configuration \u2014 Tests 4.3\/4.4\/4.5 (up to 10 MHz)
Figure N.6 \u2014 Extension of Unipolar Injection Configuration for multi-port multi-polar devices- applicable to tests 4.3\/4.4\/4.5 (up to 10 MHz) <\/td>\n<\/tr>\n
131<\/td>\nFigure N.7 \u2014 Extension of Unipolar Injection Configuration for multi-port multi-polar devices. Example of a DR pacemaker
Figure N.8 \u2014 Extension of Unipolar Injection Configuration for multi-port multi-polar devices. Example of a DF-1 CRT-D <\/td>\n<\/tr>\n
132<\/td>\nFigure N.9 \u2014 Extension of Unipolar Injection Configuration for multi-port multi-polar devices. Example of a DF-4 IS-4 CRT-D <\/td>\n<\/tr>\n
133<\/td>\nN.5 Multipolar Common Mode Injection Configuration \u2014 Tests 4.3\/4.4\/4.5 (up to 10 MHz)
Figure N.10 \u2014 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) <\/td>\n<\/tr>\n
134<\/td>\nFigure N.11 \u2014 Extension of Multipolar Common Mode Injection Configuration for multi-port multi-polar devices. Example of a DR pacemaker <\/td>\n<\/tr>\n
135<\/td>\nFigure N.12 \u2014 Extension of Multipolar Common Mode Injection Configuration for multi-port multi-polar devices. Example of a DF-1 CRT-D <\/td>\n<\/tr>\n
136<\/td>\nFigure N.13 \u2014 Extension of Multipolar Common Mode Injection Configuration for multi-port multi-polar devices. Example of a DF-4 IS-4 CRT-D <\/td>\n<\/tr>\n
137<\/td>\nN.6 Multipolar Differential Mode Injection Configuration \u2014 Tests 4.3\/4.4\/4.5 (up to 10 MHz)
Figure N.14 \u2014 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) <\/td>\n<\/tr>\n
138<\/td>\nFigure N.15 \u2014 Extension of Bipolar Differential Mode Injection Configuration for multi-port multi-polar devices. Example of a DR pacemaker <\/td>\n<\/tr>\n
140<\/td>\nFigure N.16 \u2014 Extension of Bipolar Differential Mode Injection Configuration for multi-port multi-polar devices. Example of a DF-1 CRT-D <\/td>\n<\/tr>\n
143<\/td>\nFigure N.17 \u2014 Extension of Bipolar Differential Mode Injection Configuration for multi-port multi-polar devices. Example of a DF-4 IS-4 CRT-D <\/td>\n<\/tr>\n
145<\/td>\nAnnex 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 <\/td>\n<\/tr>\n
146<\/td>\nFigure O.1 \u2014 Test signal 1: CW exposure <\/td>\n<\/tr>\n
147<\/td>\nFigure O.2 \u2014 Test signal 2: Burst-modulated exposure (for illustration purposes modulation parameters B and T are not scaled) <\/td>\n<\/tr>\n
148<\/td>\nO.3 ICDs and CRT-D devices
O.4 Rationale for test signal modulation <\/td>\n<\/tr>\n
149<\/td>\nFigure O.3 \u2014 Biot-Savart law for a circular current loop emitter; Bz is the B-field component along the z-axis perpendicular to the current loop <\/td>\n<\/tr>\n
150<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n152<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198336,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198329","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198329","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198336"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198329"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198329"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198329"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}