We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
  • ISO 25539-1:2017

    Current The latest, up-to-date edition.
    Add to Watchlist
    This Standard has been added successfully to your Watchlist
    Please visit My Watchlist to see all standards that you are watching.
    Please log in or to add this standard to your Watchlist.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    We could not add this standard to your Watchlist.
    Please retry or contact support for assistance.
    You have already added this standard to your Watchlist.
    Visit My Watchlist to view the full list.

    Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  27-01-2017

    Publisher:  International Organization for Standardization

    Add to Watchlist

    Add To Cart

    Abstract - (Show below) - (Hide below)

    ISO 25539-1:2017 specifies 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. Guidance for the development of in vitro test methods is included in an informative annex to this document. This document can be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

    ISO 25539-1:2017 is applicable to endovascular systems used to treat aneurysms, stenoses or other vascular anomalies or pathologies (e.g. dissections, transections) or to create shunts between vessels [e.g. creation of transjugular intrahepatic portosystemic shunting (TIPS)]. Some of the requirements are specific to endovascular treatment of arterial aneurysms or stenoses. Although uses of endovascular systems other than treatment of arterial aneurysms or stenoses (e.g. dissections, transections, shunts) are within the scope of this document, the specific requirements and testing are not described. Similarly, specific prosthesis configurations (e.g. fenestrated, branched) are within the scope, but specific requirements and testing are not described for these devices.

    ISO 25539-1:2017 is not applicable to vascular occluders, with the exception of contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis. Although contra-lateral iliac artery occluders when used as an integral part of aorto-uni-iliac endovascular prosthesis are within the scope of this document, specific requirements and testing are not described for these devices.

    Balloons used to achieve adequate apposition of the prosthesis with the vessel wall or overlapping components are within the scope of this document, even if they are not integral to the endovascular system. This document provides requirements beyond the requirements of ISO 10555‑4, specific to the use of balloons with endovascular prostheses.

    ISO 25539-1:2017 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.

    The valve component of valved conduits constructed with an endovascular prosthesis component and the combination of the valved component and the endovascular prosthesis component are excluded from the scope of this document. This document can be helpful in identifying the appropriate evaluation of the endovascular prosthesis component of a valved conduit, but specific requirements and testing are not described for these devices.

    NOTE 1 Cardiac valved conduits are within the scope of ISO 5840‑1.

    Pharmacological aspects of drug eluting or drug coated endovascular prostheses are not addressed in this document.

    NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417.

    ISO 25539-1:2017 does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of endovascular prostheses.

    The requirements for, and the evaluation of, degradation and other time-dependant aspects of absorbable materials used in the construction of endovascular prostheses are not addressed in this document.

    NOTE 3 Absorbable materials are within the scope of ISO/TS 17137 and ISO/TR 37137.

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

    Development Note Supersedes ISO/DIS 25539-1. (01/2017)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    DIN EN ISO 12417-1 E : 2016 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    BS EN ISO 5840-2:2015 Cardiovascular implants. Cardiac valve prostheses Surgically implanted heart valve substitutes
    ISO 5910:2018 Cardiovascular implants and extracorporeal systems Cardiac valve repair devices
    ANSI/AAMI/ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
    AAMI ISO 5840-1 : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
    I.S. EN ISO 5840-1:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 5840-1:2015)
    ASTM F 3211 : 2017 Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
    ISO 7198:2016 Cardiovascular implants and extracorporeal systems — Vascular prostheses — Tubular vascular grafts and vascular patches
    I.S. EN ISO 5840-3:2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES (ISO 5840-3:2013)
    14/30281560 DC : 0 BS EN ISO 5840-2 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES
    UNI EN ISO 5840-3 : 2013 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY TRANSCATHETER TECHNIQUES
    ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products
    I.S. EN ISO 12417-1:2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    ASTM F 3036 : 2013 Standard Guide for Testing Absorbable Stents
    DIN EN ISO 5840-2 E : 2016 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
    EN ISO 5840-2:2015 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
    EN ISO 5840-1:2015 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
    UNE-EN ISO 5840-2:2016 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
    14/30270462 DC : 0 BS EN ISO 5840-1 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS
    DD ISO/TS 12417:2011 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products
    BS EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products General requirements
    17/30250386 DC : 0 BS ISO 17327-1 - NON-ACTIVE SURGICAL IMPLANTS - IMPLANT COATING - PART 1: GENERAL REQUIREMENTS
    BS EN ISO 5840-1:2015 Cardiovascular implants. Cardiac valve prostheses General requirements
    BS EN ISO 5840-3:2013 Cardiovascular implants. Cardiac valve prostheses Heart valve substitutes implanted by transcatheter techniques
    UNE-EN ISO 5840-1:2016 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    DIN EN ISO 7198 E : 2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
    DIN EN ISO 5840-2:2016-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015)
    DIN EN ISO 5840-1:2015-12 Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (ISO 5840-1:2015)
    I.S. EN ISO 5840-2:2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 2: SURGICALLY IMPLANTED HEART VALVE SUBSTITUTES (ISO 5840-2:2015)
    UNE-EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    14/30251609 DC : 0 BS EN ISO 12417-1 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    11/30219211 DC : 0 BS EN ISO 5840-3 - CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 3: HEART VALVE SUBSTITUTES IMPLANTED BY MINIMALLY INVASIVE TECHNIQUES
    DIN EN ISO 7198:2017-07 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    UNE-EN ISO 12417-1:2016 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    ISO/TR 12417-2:2017 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
    AAMI ISO 12417-1 : 2015 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS
    ISO 5840-3:2013 Cardiovascular implants Cardiac valve prostheses Part 3: Heart valve substitutes implanted by transcatheter techniques
    ISO 5840-2:2015 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes
    ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems Vascular device-drug combination products Part 1: General requirements
    EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
    EN ISO 12417-1:2015 Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
    AAMI ISO TIR 12417 : 2011 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS
    DIN EN ISO 5840-3:2013-06 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
    DIN EN ISO 5840-1 E : 2015 CARDIOVASCULAR IMPLANTS - CARDIAC VALVE PROSTHESES - PART 1: GENERAL REQUIREMENTS (ISO 58401:2015)
    BS EN ISO 7198:2017 Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches
    DIN EN ISO 12417-1:2016-02 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR DEVICE-DRUG COMBINATION PRODUCTS - PART 1: GENERAL REQUIREMENTS (ISO 12417-1:2015)
    UNE-EN ISO 5840-3:2013 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2013)
    16/30310949 DC : 0 BS ISO 5910 - CARDIOVASCULAR IMPLANTS AND EXTRACOPOREAL SYSTEMS - CARDIAC VALVE REPAIR DEVICES
    ISO 17327-1:2018 Non-active surgical implants — Implant coating — Part 1: General requirements
    I.S. EN ISO 7198:2017 CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016)
    ISO 5840-1:2015 Cardiovascular implants Cardiac valve prostheses Part 1: General requirements

    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 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
    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
    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
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective
Need help?
Call us on 131 242, then click here to start a Screen Sharing session
so we can help right away! Learn more