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    I.S. EN ISO 25539-1:2017

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    CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  National Standards Authority of Ireland

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    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.

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

    National Foreword
    European foreword
    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
    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

    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 Supersedes I.S. EN 14299. (12/2008) Supersedes I.S. EN 12006-3. (03/2011)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current
    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
    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
    EN 556:1994 + A1:1998 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE"
    ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
    ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
    EN 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 14937:2009)
    EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
    EN ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
    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
    EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)
    ISO 10993-13:2010 Biological evaluation of medical devices Part 13: Identification and quantification of degradation products from polymeric 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
    EN ISO 14155:2011/AC:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011)
    ISO/TS 17665-2:2009 Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1
    ISO 17475:2005 Corrosion of metals and alloys Electrochemical test methods Guidelines for conducting potentiostatic and potentiodynamic polarization measurements
    EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:2010)
    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
    EN ISO 10993-9:2009 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)
    ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
    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
    EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
    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)
    EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    CEN ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
    EN 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 11135:2014)
    EN ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
    ISO 10993-14:2001 Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics
    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
    ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials
    EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
    ISO/TS 10993-19:2006 Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
    ASTM F 2052 : 2015 : REDLINE Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    EN ISO 11137-2:2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
    ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 11137-3:2017 Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control
    ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
    ASTM F 2213 : 2017 : REDLINE Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    EN ISO 10993-18:2009 Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
    ISO 10555-1:2013 Intravascular catheters Sterile and single-use catheters Part 1: General requirements
    EN ISO 11137-1:2015 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)
    ASTM F 2942 : 2013 Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
    EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
    ISO 10993-9:2009 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
    EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
    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
    EN 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 (ISO 17665-1:2006)
    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 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    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 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
    EN ISO 10993-15:2009 Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2000)
    EN ISO 10993-14:2009 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics (ISO 10993-14:2001)
    EN ISO 10993-1:2009/AC:2010 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
    EN ISO 11137-3:2017 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
    EN 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 14160:2011)
    ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
    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
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    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
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