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    I.S. EN ISO 25539-3:2011

    Current The latest, up-to-date edition.

    CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 3: VENA CAVA FILTERS (ISO 25539-3:2011)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2011

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Intended performance
    6 Design attributes
    7 Materials
    8 Design evaluation
    9 Post-market surveillance
    10 Manufacturing
    11 Sterilization
    12 Packaging
    Annex A (informative) - Attributes of endovascular devices
            - Vena cava filters - Technical and clinical
            considerations
    Annex B (informative) - Descriptions of potential device
            effects of failure and failure modes and descriptions
            of detrimental clinical effects
    Annex C (informative) - Bench and analytical tests
    Annex D (informative) - Test methods
    Annex E (informative) - Examples of terms for clinical use
            of vena cava filters
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Describes requirements for vena cava filters, based upon current medical knowledge.

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

    Development Note Supersedes I.S. EN 12006-3. (01/2012)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 10555-2:1996 Sterile, single-use intravascular catheters Part 2: Angiographic catheters
    ASTM F 2503 : 2013 : REDLINE Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
    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
    ISO/TR 14969:2004 Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 14630:2012 Non-active surgical implants General requirements
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    ISO/TS 15539:2000 Cardiovascular implants Endovascular prostheses
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    EN 12006-3:1998+A1:2009 Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
    ISO 10555-3:2013 Intravascular catheters — Sterile and single-use catheters — Part 3: Central venous catheters
    CFR 21(PTS1-99) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99
    ISO 10555-1:2013 Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    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
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    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
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