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BS EN ISO 25539-1:2017

Current
Current

The latest, up-to-date edition.

Cardiovascular implants. Endovascular devices Endovascular prostheses
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

04-05-2018

This document 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 ISO14630, which specifies general requirements for the performance of non-active surgical implants.

This document 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.

This document 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 ISO10555-4, specific to the use of balloons with endovascular prostheses.

This document 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.

NOTE1 Cardiac valved conduits are within the scope of ISO5840-1.

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

NOTE2 Vascular device-drug combination products are within the scope of ISO12417.

This document does not address the requirements for, and the evaluation of, viable tissues and nonviable 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.

NOTE3 Absorbable materials are within the scope of ISO/TS17137 and ISO/TR37137.

Committee
CH/150/2
DevelopmentNote
Renumbers and supersedes BS ISO 25539-1. Supersedes 01/563350 DC. 2009 version incorporates corrigendum to BS ISO 25539-1. (12/2009) Supersedes 04/30098755 DC. (01/2010) Together with BS EN ISO 25539-2, it supersedes BS EN 14299. (06/2011) Together with BS EN ISO 25539-2 & BS EN ISO 25539-3, it supersedes BS EN 12006-3. (03/2012)
DocumentType
Standard
Pages
142
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN ISO 25539-1:2017 Identical
ISO 25539-1:2017 Identical

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"
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 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 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)
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)
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
EN ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2016)
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)
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
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 <emph type="bdit">in vitro</emph> 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)
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 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
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 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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