• BS 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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    Superseded date:  04-09-2019

    Language(s):  English

    Published date:  31-03-2013

    Publisher:  British Standards Institution

    Add To Cart

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

    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 - (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 CH/150/2
    Development Note Supersedes 10/30208719 DC. (03/2013)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    AAMI PC69 : 2007
    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)
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective