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  • DIN EN ISO 5840:2009-08

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-12-2015

    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 Abkürzungen
    5 Grundlegende Anforderungen
    6 Beschreibung des Geräts
    7 Prüfung und Analyse zur Verifizierung/Validierung
      der Konstruktion
    Anhang A (informativ) Begründung für die
              Festlegungen dieser Internationalen Norm
    Anhang B (informativ) Gefährdungen bei
              Herzklappenprothesen, damit zusammenhängende
              Versagensmodi und Bewertungsverfahren
    Anhang C (informativ) Leitlinien zur Risikobewertung
    Anhang D (informativ) Physikalische und
              Werkstoffeigenschaften von Herzklappenprothesen
              Und ihrer Bauteile
    Anhang E (informativ) Statistische Verfahren bei der
              Anwendung von Leistungskriterien
    Anhang F (informativ) In-vitro-Verfahren zur Prüfung
              von stentlosen oder ähnlichen Klappen in
              elastischen Kammern
    Anhang G (informativ) Präklinische Prüfungen in vivo
    Anhang H (informativ) Arbeitsvorschrift für die
              Echokardiographie
    Anhang I (informativ) Beschreibung der
              Herzklappenprothese
    Anhang J (informativ) Abbildungen von Beispielen von
              Komponenten einiger Herzklappenprothesen
    Anhang K (informativ) Beispiele anwendbarer Normen zur
              Prüfung von Werkstoffen und
              Bauteilen einiger Herzklappenprothesen
    Anhang L (informativ) Anleitung zur Überprüfung des
              hydrodynamischen Verhaltens
    Anhang M (informativ) Prüfung der Dauerhaltbarkeit
    Anhang N (informativ) Beispiele konstruktionsspezifischer
              Prüfungen
    Anhang O (informativ) Beurteilung der Ermüdungseigenschaften
    Anhang P (normativ) Verpackung
    Anhang Q (normativ) Kennzeichnung und Gebrauchsanleitung
    Anhang R (normativ) Verfahren der Auswertung klinischer Daten
    Anhang S (normativ) Sterilisation
    Literaturhinweise
    Anhang ZA (informativ) Zusammenhang zwischen dieser
              Europäischen Norm und den grundlegenden
              Anforderungen der EG-Richtlinie 93/42/EWG

    Abstract - (Show below) - (Hide below)

    Diese Internationale Norm legt Entwurfs- und minimale Leistungsspezifikationen für Herzklappenprothesen fest.

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

    Development Note Supersedes DIN EN 12006-1. (03/2006)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    VDI 5700 Blatt 1:2015-04 Reprocessing hazards - Risk management in reprocessing of medical devices - Measures for risk control

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

    DIN EN ISO 11135:2014-10 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
    DIN EN ISO 11607-1:2014-11 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014)
    EN 12442-3 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE AGENTS
    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    DIN EN ISO 13485:2016-08 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
    DIN EN ISO 10993-2:2006-10 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 14155-1:2003 Clinical investigation of medical devices for human subjects Part 1: General requirements
    DIN EN ISO 11137-1:2015-11 STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013)
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    DIN EN ISO 11137-3:2015-08 (Draft) STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017)
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    DIN EN ISO 14155-1:2009-11 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    ISO 532:1975 Acoustics Method for calculating loudness level
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    EN 12442-1 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    DIN EN ISO 14160:2011-10 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    MIL-STD-1629 Revision A:1980 PROCEDURES FOR PERFORMING A FAILURE MODE, EFFECTS AND CRITICALITY ANALYSIS
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters
    EN 12442-2 : 2000 ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
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