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  • DIN EN ISO 25539-1:2017-09

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)

    Available format(s):  Hardcopy, PDF

    Superseded date:  07-03-2021

    Language(s):  English

    Published date:  01-01-2017

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

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

    National foreword
    National Annex NA (informative) - Bibliography
    European foreword
    Annex ZA (informative) - Relationship between
             this European Standard and the Essential
             Requirements of EU Directive 93/42/EEC
             [OJ L 169] aimed to be covered
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements for endovascular system
    5 Intended performance
    6 Design attributes
    7 Materials
    8 Design evaluation
    9 Post-market surveillance
    10 Manufacturing
    11 Sterilization
    12 Packaging
    Annex A (informative) - Relationship between testing
            requirements and device attributes and potential
            failure modes
    Annex B (informative) - Description of clinical and
            device effects of failure
    Annex C (informative) - Bench and analytical tests
    Annex D (informative) - Test methods
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for the evaluation of endovascular systems (prostheses and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer based upon current medical knowledge.

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

    Development Note Together with DIN EN ISO 25539-2 E, it supersedes DIN EN 14299 E. (03/2009) DIN EN ISO 25539-1 E issue 08-2009 remains valid alongside this standard until 15-03-2020. (09/2017)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Supersedes

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    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
    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 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    ISO/TR 37137:2014 Cardiovascular biological evaluation of medical devices — Guidance for absorbable implants
    ISO 17475:2005 Corrosion of metals and alloys Electrochemical test methods Guidelines for conducting potentiostatic and potentiodynamic polarization measurements
    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
    ASTM F 3044 : 2014 Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants
    ISO 5840-1:2015 Cardiovascular implants Cardiac valve prostheses Part 1: General requirements
    ASTM F 3067 : 2014 Guide for Radial Loading of Balloon Expandable and Self Expanding Vascular Stents
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO/TS 17137:2014 Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    ASTM F 2942 : 2013 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
    ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ASTM F 2914 : 2012 Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
    DIN EN ISO 7198 E : 2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    ISO 17665-1:2006 Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
    ASTM F 640 : 2012 : REDLINE Standard Test Methods for Determining Radiopacity for Medical Use
    ISO 10555-4:2013 Intravascular catheters — Sterile and single-use catheters — Part 4: Balloon dilatation catheters
    ISO 16429:2004 Implants for surgery Measurements of open-circuit potential to assess corrosion behaviour of metallic implantable materials and medical devices over extended time periods
    DIN EN ISO 5840-1 E : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
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