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  • 01/564791 DC : DRAFT NOV 2001

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN 14299 - NON ACTIVE SURGICAL IMPLANTS - PARTICULAR REQUIREMENTS FOR CARDIAC AND VASCULAR IMPLANTS - SPECIFIC REQUIREMENTS FOR ARTERIAL STENTS

    Available format(s): 

    Superseded date:  08-06-2004

    Language(s): 

    Published date:  23-11-2012

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Intended performance
    5 Design attributes
    6 Materials
    7 Design evaluation
    8 Manufacturing
    9 Sterilization
    10 Packaging
    11 Information supplied by the manufacturer
    Annex A (informative) Table A.1 - Cross reference of specific
             aims
    Annex B (informative) Definitions of reportable clinical
             events
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other provisions
             of EU Directives

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

    Comment Closes On
    Committee CH/23
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    EN 12006-2:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
    ISO 5840:2005 Cardiovascular implants Cardiac valve prostheses
    ISO 10555-2:1996 Sterile, single-use intravascular catheters Part 2: Angiographic catheters
    ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
    EN 540 : 1993 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS
    EN 12006-3:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    ISO 10555-4:2013 Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
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