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  • UNI EN 12006-2 : 2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 2: VASCULAR PROSTHESES INCLUDING CARDIAC VALVE CONDUITS

    Available format(s): 

    Superseded date:  19-10-2017

    Language(s): 

    Published date:  01-01-2009

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 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 (normative) - Classification of prostheses
    Annex B (informative) - Bibliography
    Annex C (informative) - Reference table EN 12006-2 and
            ISO/DIS 7198
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Deals with specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.

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

    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    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
    ISO 2960:1974 Textiles Determination of bursting strength and bursting distension Diaphragm method
    ISO 5084:1996 Textiles Determination of thickness of textiles and textile products
    ISO 2076:2013 Textiles Man-made fibres Generic names
    ISO 2859-2:1985 Sampling procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
    EN ISO 10993-7 : 2008 COR 2009 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS (ISO 10993-7:2008/COR 1:2009)
    ISO 5081:1977 Textiles Woven fabrics Determination of breaking strength and elongation (Strip method)
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 472:2013 Plastics Vocabulary
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
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