ISO 14117:2019

INTERNATIONAL ISO
STANDARD 14117
Second edition
2019-09
Active implantable medical devices —
Electromagnetic compatibility —
EMC test protocols for implantable
cardiac pacemakers, implantable
cardioverter defibrillators and cardiac
resynchronization devices
Dispositifs médicaux implantables actifs — Compatibilité
électromagnétique — Protocoles d'essai EMC pour pacemakers
cardiaques implantables, défibrillateurs implantables et dispositifs de
resynchronisation cardiaque
Reference number
©
ISO 2019
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions, symbols and abbreviated terms . 1
3.1 Terms and definitions . 1
3.2 Acronyms and abbreviations . 3
4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz . 4
4.1 General requirements for all devices . 4
4.2 Induced lead current . 5
4.2.1 General requirements . 5
4.2.2 Pacemakers and CRT-P devices . 5
4.2.3 ICDs and CRT-D devices . 9
4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields .12
4.3.1 General requirements .12
4.3.2 Pacemaker and CRT-P devices .12
4.3.3 ICDs and CRT-D devices .17
4.4 Protection from malfunction caused by temporary exposure to CW sources .23
4.4.1 Pacemaker and CRT-P device' response to temporary continuous wave
sources in the frequency range 16,6 Hz to 167 kHz .23
4.4.2 ICDs and CRT-D devices .25
4.5 Protection from sensing EMI as cardiac signals .26
4.5.1 General requirements .26
4.5.2 Protection from sensing EMI as cardiac signals in the frequency range of
16,6 Hz to 150 kHz .27
4.5.3 Protection from sensing EMI as cardiac signals in the frequency range of
150 kHz to 10 MHz .30
4.5.4 Protection from sensing EMI as cardiac signals in the frequency range of
10 MHz to 385 MHz .33
4.6 Protection from static magnetic fields of flux density up to 1 mT.35
4.6.1 General requirements .35
4.6.2 Pacemakers and CRT-P devices .35
4.6.3 ICDs and CRT-D devices .36
4.7 Protection from static magnetic fields of flux density up to 50 mT .37
4.7.1 General requirements .37
4.7.2 Pacemakers and CRT-P devices .37
4.7.3 ICDs and CRT-D devices .37
4.8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz .37
4.8.1 General requirements .37
4.8.2 Pacemakers and CRT-P devices .37
4.8.3 ICDs and CRT-D devices .38
4.9 Test requirements for the frequency range of 385 MHz ≤ ƒ ≤ 3 000 MHz .38
4.9.1 General requirements .38
4.9.2 Test setup .39
4.9.3 Test procedure .40
4.9.4 Performance criteria .42
4.10 Transient exposure to stationary low-frequency electromagnetic field sources in
the frequency range 16,6 Hz to 167 kHz .43
5 Testing above frequency of 3 000 MHz .43
6 Protection of devices from EM fields encountered in a therapeutic environment .43
6.1 Protection of the device from damage caused by high-frequency surgical exposure .43
6.1.1 General requirements .43
6.1.2 Pacemakers and CRT-P devices .44
6.1.3 ICDs and CRT-D devices .44
6.2 Protection of the device from damage caused by external defibrillators .45
6.2.1 General requirements .45
6.2.2 Pacemakers and CRT-P devices .45
6.2.3 ICDs and CRT-D devices .48
7 Additional accompanying documentation .49
7.1 Disclosure of permanently programmable sensitivity settings .49
7.2 Descriptions of reversion modes.49
7.3 Known potential hazardous behaviour .49
7.4 Minimum separation distance from hand-held transmitters .49
Annex A (informative) Rationale .50
Annex B (informative) Rationale for test frequency ranges .63
Annex C (informative) Code for describing modes of implantable generators .64
Annex D (normative) Interface circuits .66
Annex E (informative) Selection of capacitor C .71
x
Annex F (normative) Calibration of the injection network (Figure D.5) .74
Annex G (normative) Torso simulator .76
Annex H (normative) Dipole antennas .80
Annex I (normative) Pacemaker/ICD programming settings .82
Annex J (normative) Simulated cardiac signal .84
Annex K (normative) Calculation of net power into dipole antenna .85
Annex L (informative) Loop area calculations.90
Annex M (informative) Correlation between levels of test voltages used in this document
and strengths of radiated fields .96
Annex N (informative) Connections to DUTs having ports with more than two electrode
connections .104
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 .127
Bibliography .132
iv © ISO 2019 – All rights reserved

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO techni
...