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  • BS EN 14299:2004

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Non-active surgical implants. Particular requirements for cardiac and vascular implants. Specific requirements for arterial stents

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2009

    Language(s):  English

    Published date:  08-06-2004

    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 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) 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
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes specific requirements for arterial stents and endovascular prostheses and their deployment intended to correct or compensate for a defect of an artery.

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

    Committee CH/150/2
    Development Note Supersedes 01/564791 DC. (06/2004)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    ISO 14155-2:2003 Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
    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 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    ISO 14630:2012 Non-active surgical implants General requirements
    EN ISO 10555-4:2013 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters (ISO 10555-4:2013)
    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 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans (ISO 14155-2:2003)
    EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003)
    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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