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BS ISO 14117:2019

BS ISO 14117:2019

$215.11

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
BSI 2019 146
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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 ?  ƒ < 385 MHz;

  • 385 MHz ?  ƒ ? 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.

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
11 1 Scope
2 Normative references
3 Terms, definitions, symbols and abbreviated terms
3.1 Terms and definitions
13 3.2 Acronyms and abbreviations
14 4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz
4.1 General requirements for all devices
15 4.2 Induced lead current
4.2.1 General requirements
4.2.2 Pacemakers and CRT-P devices
19 4.2.3 ICDs and CRT-D devices
22 4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields
4.3.1 General requirements
4.3.2 Pacemaker and CRT-P devices
27 4.3.3 ICDs and CRT-D devices
33 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
35 4.4.2 ICDs and CRT-D devices
36 4.5 Protection from sensing EMI as cardiac signals
4.5.1 General requirements
37 4.5.2 Protection from sensing EMI as cardiac signals in the frequency range of 16,6 Hz to 150 kHz
40 4.5.3 Protection from sensing EMI as cardiac signals in the frequency range of 150 kHz to 10 MHz
43 4.5.4 Protection from sensing EMI as cardiac signals in the frequency range of 10 MHz to 385 MHz
45 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
46 4.6.3 ICDs and CRT-D devices
47 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
48 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
49 4.9.2 Test setup
50 4.9.3 Test procedure
52 4.9.4 Performance criteria
53 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
54 6.1.2 Pacemakers and CRT-P devices
6.1.3 ICDs and CRT-D devices
55 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
58 6.2.3 ICDs and CRT-D devices
59 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
60 Annex A (informative) Rationale
73 Annex B (informative) Rationale for test frequency ranges
74 Annex C (informative) Code for describing modes of implantable generators
76 Annex D (normative) Interface circuits
81 Annex E (informative) Selection of capacitor Cx
84 Annex F (normative) Calibration of the injection network (Figure D.5)
86 Annex G (normative) Torso simulator
90 Annex H (normative) Dipole antennas
92 Annex I (normative) Pacemaker/ICD programming settings
94 Annex J (normative) Simulated cardiac signal
95 Annex K (normative) Calculation of net power into dipole antenna
100 Annex L (informative) Loop area calculations
106 Annex M (informative) Correlation between levels of test voltages used in this document and strengths of radiated fields
114 Annex N (informative) Connections to DUTs having ports with more than two electrode connections
137 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
142 Bibliography

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BS ISO 14117:2019
$215.11