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  • AAMI TIR41 : 2011

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  25-01-2020

    Language(s):  English

    Published date:  01-01-2011

    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
    Foreword
    1 Scope
    2 Normative references
    3 Definitions
    4 High-voltage lead connector shock
      electrode labels
    5 Color labeling of DF-1 lead connectors
    6 Color labeling and nomenclature of IS-1
      connectors for biventricular devices
      (for CRT)
    7 Color labeling of DF4 lead connectors
    8 Color label for IS4 lead connectors
    9 Lead length labeling Annexes
    Annexes
    A - Rationale
    B - Marking examples

    Abstract - (Show below) - (Hide below)

    Specifies guidance for the color coding and marking of IS-1, DF-1, IS4, and DF4 connectors to reduce the potential for lead-to-pulse generator connection errors during implant surgery.

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

    Document Type Standard
    Publisher Association for the Advancement of Medical Instrumentation
    Status Superseded
    Superseded By

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

    ISO 14708-2:2012 Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers
    ISO 14708-1:2014 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
    ISO 5841-3:2013 Implants for surgery — Cardiac pacemakers — Part 3: Low-profile connectors (IS-1) for implantable pacemakers
    ISO 27186:2010 Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11318:2002 Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements
    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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