• AAMI ISO 14117 : 2012

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    ACTIVE IMPLANTABLE MEDICAL DEVICES - ELECTROMAGNETIC COMPATIBILITY - EMC TEST PROTOCOLS FOR IMPLANTABLE CARDIAC PACEMAKERS, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CARDIAC RESYNCHRONIZATION DEVICES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-10-2019

    Language(s):  English

    Published date:  01-01-2012

    Publisher:  Association for the Advancement of Medical Instrumentation

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    Table of Contents - (Show below) - (Hide below)

    Glossary of equivalent standards
    Committee representation
    Background of ANSI/AAMI adoption of ISO 14117:2012
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions, symbols and abbreviations
    4 Test requirements for the frequency band 0 Hz
      <= f <= 3,000 MHz
    5 Testing above frequency of 3,000 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 - (Show below) - (Hide below)

    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 - (Show below) - (Hide below)

    Committee PC
    Development Note Supersedes AAMI PC69. (01/2013)
    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    SAE J 2954 : 2017 WIRELESS POWER TRANSFER FOR LIGHT-DUTY PLUG-IN/ELECTRIC VEHICLES AND ALIGNMENT METHODOLOGY

    Standards Referencing This Book - (Show below) - (Hide below)

    EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
    EN 50061 : 88 AMD 1 95 SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
    IEEE C95.1-2005 IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz
    ANSI C63.5 : 2006 ELECTROMAGNETIC COMPATIBILITY - RADIATED EMISSION MEASUREMENTS IN ELECTROMAGNETIC INTERFERENCE (EMI) CONTROL - CALIBRATION AND QUALIFICATION OF ANTENNAS (9 KHZ TO 40 GHZ)
    IEEE C95.6-2002 IEEE Standard for Safety Levels With Respect to Human Exposure to Electromagnetic Fields, 0-3 kHz
    DIN VDE 0848-3-1 : DRAFT 2002 SAFETY IN ELECTRICAL, MAGNETIC AND ELECTROMAGNETIC FIELDS - PART 3-1: PROTECTION OF PERSONS WITH ACTIVE IMPLANTS IN THE FREQUENCY RANGE 0 HZ TO 300 GHZ
    EN 45502-2-1:2003 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
    EN 45502-2-2 : 2008 COR 2009 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
    ISO 14708-6:2010 Implants for surgery Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
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