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  • ISO 11318:2002

    Current The latest, up-to-date edition.

    Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements

    Available format(s):  PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French

    Published date:  15-08-2002

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    This International Standard specifies a unipolar connector assembly, DF-1, intended for use in connecting implantable defibrillator leads to implantable defibrillator generators that do not produce more than 1 kV/50 A peak output. Essential dimensions and performance requirements related to connector fit are specified, along with test methods.

    This International Standard does not specify other connector features such as fastening means and material. This International Standard is applicable to the form and fit of the connector assembly, and does not address all aspects of functional compatibility, system performance, or reliability of different implantable defibrillator leads and implantable defibrillator generator assemblies.

    General Product Information - (Show below) - (Hide below)

    Committee ISO/TC 150/SC 6
    Development Note Supersedes ISO/DIS 11318 (08/2002)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    NF EN 45502-2-1 : 2004 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT BRADYARRHYTHMIA (CARDIAC PACEMAKERS)
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    AAMI ISO 27186 : 2010 ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
    08/30191626 DC : DRAFT OCT 2008 BS ISO 27186 - ACTIVE IMPLANTABLE MEDICAL DEVICES - FOUR-POLE CONNECTOR SYSTEM FOR IMPLANTABLE CARDIAC RHYTHM MANAGEMENT DEVICES - DIMENSIONAL AND TEST REQUIREMENTS
    BS ISO 27186:2010 Active implantable medical devices. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements
    BS EN 45502-2-1:2003 Active implantable medical devices 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)
    08/30191609 DC : DRAFT DEC 2008 BS ISO 14708-6 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 6: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDING IMPLANTABLE DEFIBRILLATORS)
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS EN 45502-2-2:2008 Active implantable medical devices 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)
    ISO 27186:2010 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
    ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
    AAMI TIR41 : 2011 ACTIVE IMPLANTABLE MEDICAL DEVICES - GUIDANCE FOR DESIGNATION OF LEFT VENTRICLE AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD CONNECTORS AND PULSE GENERATOR CONNECTOR CAVITIES FOR IMPLANTABLE PACEMAKERS AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
    NF EN 45502-2-2 : 2008 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
    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)
    I.S. EN 45502-2-2:2008 ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: PARTICULAR REQUIREMENTS FOR ACTIVE IMPLANTABLE MEDICAL DEVICES INTENDED TO TREAT TACHYARRHYTHMIA (INCLUDES IMPLANTABLE DEFIBRILLATORS)
    I.S. EN 45502-2-1:2004 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)
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