M00027571
New product
ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY - EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEVICES
International Organization for Standardization
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Availability date: 11/05/2021
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions, symbols and abbreviations
4 Test requirements for the frequency band 0 Hz <= f
<= 3000 MHz
5 Testing above frequency of 3000 MHz
6 Protection of devices from EM fields encountered in
a therapeutic environment
7 Additional accompanying documentation
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 C[x]
Annex F (normative) - Calibration of the injection network
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
Describes 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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | International Organization for Standardization |
Pages | |
ISBN | |
Committee | TC 150 |