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  • BS ISO 27186:2010

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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. Four-pole connector system for implantable cardiac rhythm management devices. Dimensional and test requirements

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-12-2020

    Language(s):  English

    Published date:  31-08-2013

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    Annex A (normative) - Electrical isolation test
    Annex B (informative) - Rationale for Annex A
    Annex C (normative) - Dielectric strength test
    Annex D (informative) - Rationale for Annex C
    Annex E (normative) - Current-carrying test high
            voltage types
    Annex F (informative) - Rationale for Annex E
    Annex G (informative) - Lead connector fatigue strength test
    Annex H (informative) - Lead connector seal zone materials
    Annex I (informative) - Seal zone creep
    Annex J (informative) - Contact resistance stability
    Annex K (informative) - Rationale for Annex J
    Annex L (informative) - Selection of contact materials
    Annex M (normative) - Lead connector contact material
            requirements
    Annex N (informative) - Rationale for Annex M
    Annex O (informative) - Rationale for requirements in this
            International Standard
    Annex P (informative) - Connector products (e.g. adaptors,
            extenders, patient cables, etc.)
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes a four-pole connector system for implantable cardiac rhythm management devices which have pacing, electrogram sensing and/or defibrillation functions.

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

    Committee CH/150/2
    Development Note Supersedes 08/30191626 DC. (08/2013)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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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