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  • DIN EN 12006-2:2009-08

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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):  Hardcopy, PDF

    Superseded date:  01-07-2017

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Vorwort
    Einleitung
    1 Anwendungsbereich
    2 Normative Verweisungen
    3 Begriffe
    4 Beabsichtigte Funktion
    5 Konstruktionsmerkmale
    6 Werkstoffe
       6.1 Biologische Verträglichkeit und
           biologische Stabilität
       6.2 Chemische Eigenschaften - Nomenklatur
    7 Beurteilung der Konstruktion
       7.1 Funktionsmerkmale
           7.1.1 Verbundprothesen
           7.1.2 Kombinierte Prothesen
           7.1.3 Kombinierte kardiovaskuläre
                 Prothesen (Klappen-Konduit)
       7.2 Anforderungen an Prothesen im
           Endzustand
       7.3 Probenahme
       7.4 Prüfverfahren
       7.5 Vorklinische Bewertung in vivo
       7.6 Klinische Bewertung
       7.7 Prüfberichte
    8 Herstellung
    9 Sterilisation
    10 Verpackung
    11 Bereitstellung von Informationen durch
       den Hersteller
    Anhang A (normativ) Klassifizierung von Prothesen
    Anhang B (informativ) Literaturverzeichnis
    Anhang C (informativ) Gegenüberstellung von
              EN 12006-2 und ISO/DIS 7198
    Anhang ZA (informativ) Zusammenhang zwischen
              dieser Europäischen Norm und den grundlegenden
              Anforderungen der EG-Richtlinie 93/42/EWG

    Abstract - (Show below) - (Hide below)

    Das Dokument legt besondere Anforderungen für Gefässprothesen und kardiovaskuläre Patches synthetischer oder biologischer Herkunft fest, die im menschlichen Herz-Gefäss-system zum Ersatz, zur Rekonstruktion, zum Bypassaufbau oder zur Shuntbildung zwischen diesen Teilen bestimmt sind.

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    Development Note A transition period, as set out in DIN EN ISO 7198 issue 08-2009, exists until 31-03-2020. (07/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

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

    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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