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ISO 14117 : 2012

M00027571

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ISO 14117 : 2012

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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Table of Contents

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

Abstract

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.

General Product Information

Document Type Standard
Status Current
Publisher International Organization for Standardization
Committee TC 150