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  • ISO 27186:2010

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    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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    Active implantable medical devices Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements

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

    Withdrawn date:  03-12-2020

    Language(s):  English

    Published date:  18-03-2010

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 27186:2010 specifies a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions. This International Standard includes requirements for the connector portion of an implantable lead as well as for the mating connector cavity attached to an implantable pulse generator. Essential dimensions and performance requirements are specified together with appropriate test methods.

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

    Development Note Supersedes ISO/DIS 27186. (03/2010)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Withdrawn
    Superseded By

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

    EN 50527-2-2:2018 Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 2-2: Specific assessment for workers with cardioverter defibrillators (ICDs)
    17/30359914 DC : 0 BS EN 50527-2-2 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
    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 TIR 10974 : 2012 ASSESSMENT OF THE SAFETY OF MAGNETIC RESONANCE IMAGING FOR PATIENTS WITH AN ACTIVE IMPLANTABLE MEDICAL DEVICE
    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
    PREN 50527-2-2 : DRAFT 2017 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
    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
    I.S. EN 50527-2-2:2018 PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-2: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIOVERTER DEFIBRILLATORS (ICDS)
    ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device
    PD ISO/TS 10974:2012 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

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

    AAMI PC69 : 2007
    ASTM B 348 : 2013 : REDLINE Standard Specification for Titanium and Titanium Alloy Bars and Billets
    ISO 7436:1983 Slotted set screws with cup point
    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 14708-1:2014 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
    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)
    ASTM F 562 : 2013 : REDLINE Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
    ISO 11318:2002 Cardiac defibrillators — Connector assembly DF-1 for implantable defibrillators — Dimensions and test requirements
    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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